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Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Primary Purpose

Depression

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Armodafinil

Placebo

About this trial

This is an interventional treatment trial for Depression focused on measuring Bipolar I Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode.
Documentation that the patient has had at least 1 previous manic or mixed episode.
The patient has had no more than 6 mood episodes in the last year.
The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.
The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:
1. The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major depressive episode and still be taken at the time of the screening visit at dose or blood level considered appropriate for maintenance therapy by the patient's physician.
2. The patient must continue to take the same mood stabilizer(s) during the screening period; no mood stabilizer may be added during the screening period.
3. The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit.
4. The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit.
5. The mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.
6. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.

Exclusion Criteria:

The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.
The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.
The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Armodafinil 150 mg/day

Arm Description

Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.

Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.

Secondary Outcome Measures

Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.

Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression.

Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)

The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.

Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression

The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression.

Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale

The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning.

Participants With Treatment-Emergent Adverse Events (TEAE)

AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results. Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis.

Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score

The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania.

Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score

HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety.

Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score

The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia.

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit.

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit.

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit.

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit.

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit.

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit.

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit.

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit.

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit.

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit.

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit.

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit.

Full Information

NCT ID

NCT01305408

First Posted

February 25, 2011

Last Updated

April 26, 2016

Sponsor

Cephalon

1. Study Identification

Unique Protocol Identification Number

NCT01305408

Brief Title

Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Official Title

A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cephalon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Bipolar I Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

399 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.

Arm Title

Armodafinil 150 mg/day

Arm Type

Experimental

Arm Description

Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.

Intervention Type

Drug

Intervention Name(s)

Armodafinil

Other Intervention Name(s)

Nuvigil, CEP-10953

Intervention Description

Armodafinil tablets, taken orally, once daily in the morning

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo tablets, taken orally, once daily in the morning

Primary Outcome Measure Information:

Title

Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

Description

Time Frame

Day 0 (baseline), Week 8

Secondary Outcome Measure Information:

Title

Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

Description

Time Frame

Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

Description

Time Frame

Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

Description

Time Frame

Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)

Description

Time Frame

Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression

Description

Time Frame

Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale

Description

Time Frame

Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)

Title

Participants With Treatment-Emergent Adverse Events (TEAE)

Description

Time Frame

Day 1 to Week 9

Title

Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score

Description

Time Frame

Day 0 (baseline), last postbaseline observation (up to 8 weeks)

Title

Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score

Description

Time Frame

Day 0 (baseline), last postbaseline observation (up to 8 weeks)

Title

Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score

Description

Time Frame

Day 0 (baseline), last postbaseline observation (up to 8 weeks)

Title

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question

Description

Time Frame

Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question

Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit.

Time Frame

Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question

Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit.

Time Frame

Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question

Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit.

Time Frame

Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question

Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit.

Time Frame

Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question

Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit.

Time Frame

Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question

Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit.

Time Frame

Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question

Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit.

Time Frame

Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question

Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit.

Time Frame

Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit.

Time Frame

Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question

Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit.

Time Frame

Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Title

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question

Description

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit.

Time Frame

Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode. Documentation that the patient has had at least 1 previous manic or mixed episode. The patient has had no more than 6 mood episodes in the last year. The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began. The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met: The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major depressive episode and still be taken at the time of the screening visit at dose or blood level considered appropriate for maintenance therapy by the patient's physician. The patient must continue to take the same mood stabilizer(s) during the screening period; no mood stabilizer may be added during the screening period. The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit. The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit. The mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine. Exclusion Criteria: The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period. The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period. The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present. The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sponsor's Medical Expert

Organizational Affiliation

Cephalon

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 225

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

Teva Investigational Site 295

City

Sherman Oaks

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 122

City

Temecula

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 606

City

Jacksonville Beach

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 127

City

Lauderhill

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 608

City

Tampa

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 116

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 205

City

Atlanta

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 195

City

Park Ridge

State/Province

Illinois

Country

United States

Facility Name

Teva Investigational Site 611

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

Teva Investigational Site 600

City

Lafayette

State/Province

Indiana

Country

United States

Facility Name

Teva Investigational Site 603

City

Watertown

State/Province

Massachusetts

Country

United States

Facility Name

Teva Investigational Site 207

City

Brooklyn

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 202

City

New York

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 110

City

Staten Island

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 411

City

Staten Island

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 614

City

Wilmington

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 610

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 615

City

Toledo

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 401

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 609

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 616

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 406

City

Allentown

State/Province

Pennsylvania

Country

United States

Facility Name

Teva Investigational Site 403

City

Desoto

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 612

City

Friendswood

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 408

City

Salt Lake City

State/Province

Utah

Country

United States

Facility Name

Teva Investigational Site 613

City

Kirkland

State/Province

Washington

Country

United States

Facility Name

Teva Investigational Site 605

City

Spokane

State/Province

Washington

Country

United States

Facility Name

Teva Investigational Site 134

City

Buenos Aires

Country

Argentina

Facility Name

Teva Investigational Site 136

City

Buenos Aires

Country

Argentina

Facility Name

Teva Investigational Site 881

City

Buenos Aires

Country

Argentina

Facility Name

Teva Investigational Site 884

City

Buenos Aires

Country

Argentina

Facility Name

Teva Investigational Site 888

City

Buenos Aires

Country

Argentina

Facility Name

Teva Investigational Site 135

City

Córdoba Capital

Country

Argentina

Facility Name

Teva Investigational Site 236

City

Córdoba

Country

Argentina

Facility Name

Teva Investigational Site 138

City

La Plata, Buenos Aires

Country

Argentina

Facility Name

Teva Investigational Site 371

City

La Plata

Country

Argentina

Facility Name

Teva Investigational Site 886

City

La Plata

Country

Argentina

Facility Name

Teva Investigational Site 882

City

Mendoza

Country

Argentina

Facility Name

Teva Investigational Site 883

City

Mendoza

Country

Argentina

Facility Name

Teva Investigational Site 885

City

Mendoza

Country

Argentina

Facility Name

Teva Investigational Site 887

City

Mendoza

Country

Argentina

Facility Name

Teva Investigational Site 238

City

Rosario

Country

Argentina

Facility Name

Teva Investigational Site 623

City

Belo Horizonte

Country

Brazil

Facility Name

Teva Investigational Site 626

City

Curitiba-Parana

Country

Brazil

Facility Name

Teva Investigational Site 621

City

Distrito de Rubiao Junior

Country

Brazil

Facility Name

Teva Investigational Site 627

City

Itapira -Sao Paulo

Country

Brazil

Facility Name

Teva Investigational Site 624

City

Rio de Janeiro

Country

Brazil

Facility Name

Teva Investigational Site 622

City

Salvador

Country

Brazil

Facility Name

Teva Investigational Site 628

City

Sao Paolo

Country

Brazil

Facility Name

Teva Investigational Site 248

City

Bourgas

Country

Bulgaria

Facility Name

Teva Investigational Site 146

City

Kardzhali

Country

Bulgaria

Facility Name

Teva Investigational Site 148

City

Kazanlak

Country

Bulgaria

Facility Name

Teva Investigational Site 853

City

Pazardjik

Country

Bulgaria

Facility Name

Teva Investigational Site 852

City

Pleven

Country

Bulgaria

Facility Name

Teva Investigational Site 145

City

Plovdiv

Country

Bulgaria

Facility Name

Teva Investigational Site 370

City

Ruse

Country

Bulgaria

Facility Name

Teva Investigational Site 147

City

Sofia

Country

Bulgaria

Facility Name

Teva Investigational Site 149

City

Sofia

Country

Bulgaria

Facility Name

Teva Investigational Site 244

City

Sofia

Country

Bulgaria

Facility Name

Teva Investigational Site 247

City

Sofia

Country

Bulgaria

Facility Name

Teva Investigational Site 854

City

Sofia

Country

Bulgaria

Facility Name

Teva Investigational Site 855

City

Sofia

Country

Bulgaria

Facility Name

Teva Investigational Site 245

City

Varna

Country

Bulgaria

Facility Name

Teva Investigational Site 851

City

Varna

Country

Bulgaria

Facility Name

Teva Investigational Site 856

City

Varna

Country

Bulgaria

Facility Name

Teva Investigational Site 635

City

Rijeka

Country

Croatia

Facility Name

Teva Investigational Site 631

City

Split

Country

Croatia

Facility Name

Teva Investigational Site 632

City

Zagreb

Country

Croatia

Facility Name

Teva Investigational Site 633

City

Zagreb

Country

Croatia

Facility Name

Teva Investigational Site 634

City

Zagreb

Country

Croatia

Facility Name

Teva Investigational Site 716

City

Helsinki

Country

Finland

Facility Name

Teva Investigational Site 717

City

Helsinki

Country

Finland

Facility Name

Teva Investigational Site 719

City

Kangasala

Country

Finland

Facility Name

Teva Investigational Site 718

City

Turku

Country

Finland

Facility Name

Teva Investigational Site 655

City

Achim

Country

Germany

Facility Name

Teva Investigational Site 656

City

Berlin

Country

Germany

Facility Name

Teva Investigational Site 653

City

Cologne

Country

Germany

Facility Name

Teva Investigational Site 651

City

Dresden

Country

Germany

Facility Name

Teva Investigational Site 654

City

Freiburg

Country

Germany

Facility Name

Teva Investigational Site 652

City

Mittweida

Country

Germany

Facility Name

Teva Investigational Site 661

City

Budapest

Country

Hungary

Facility Name

Teva Investigational Site 662

City

Budapest

Country

Hungary

Facility Name

Teva Investigational Site 664

City

Budapest

Country

Hungary

Facility Name

Teva Investigational Site 665

City

Gyor

Country

Hungary

Facility Name

Teva Investigational Site 666

City

Nagykallo

Country

Hungary

Facility Name

Teva Investigational Site 688

City

Catania

Country

Italy

Facility Name

Teva Investigational Site 689

City

Firenze

Country

Italy

Facility Name

Teva Investigational Site 686

City

Genova

Country

Italy

Facility Name

Teva Investigational Site 691

City

Lido di Camaiore(LU)

Country

Italy

Facility Name

Teva Investigational Site 690

City

Naples

Country

Italy

Facility Name

Teva Investigational Site 687

City

Pisa

Country

Italy

Facility Name

Teva Investigational Site 693

City

Pisa

Country

Italy

Facility Name

Teva Investigational Site 692

City

Roma

Country

Italy

Facility Name

Teva Investigational Site 259

City

Bialystok

Country

Poland

Facility Name

Teva Investigational Site 257

City

Gdansk

Country

Poland

Facility Name

Teva Investigational Site 258

City

Gdynia

Country

Poland

Facility Name

Teva Investigational Site 155

City

Krakow

Country

Poland

Facility Name

Teva Investigational Site 255

City

Skorzewo

Country

Poland

Facility Name

Teva Investigational Site 861

City

Szczecin

Country

Poland

Facility Name

Teva Investigational Site 157

City

Tuszyn

Country

Poland

Facility Name

Teva Investigational Site 177

City

Belgrade

Country

Serbia

Facility Name

Teva Investigational Site 831

City

Belgrade

Country

Serbia

Facility Name

Teva Investigational Site 832

City

Belgrade

Country

Serbia

Facility Name

Teva Investigational Site 835

City

Belgrade

Country

Serbia

Facility Name

Teva Investigational Site 176

City

Kragujevac

Country

Serbia

Facility Name

Teva Investigational Site 837

City

Nis

Country

Serbia

Facility Name

Teva Investigational Site 834

City

Novi Knezevac

Country

Serbia

Facility Name

Teva Investigational Site 700

City

Bojnice

Country

Slovakia

Facility Name

Teva Investigational Site 699

City

Bratislava

Country

Slovakia

Facility Name

Teva Investigational Site 697

City

Rimavska Sobota

Country

Slovakia

Facility Name

Teva Investigational Site 696

City

Roznava

Country

Slovakia

Facility Name

Teva Investigational Site 698

City

Trencin

Country

Slovakia

Facility Name

Teva Investigational Site 707

City

Cape Town

Country

South Africa

Facility Name

Teva Investigational Site 709

City

Cape Town

Country

South Africa

Facility Name

Teva Investigational Site 712

City

Cape Town

Country

South Africa

Facility Name

Teva Investigational Site 708

City

Centurion

Country

South Africa

Facility Name

Teva Investigational Site 710

City

Johannesburg

Country

South Africa

Facility Name

Teva Investigational Site 711

City

Paarl

Country

South Africa

Facility Name

Teva Investigational Site 706

City

Pretoria

Country

South Africa

Facility Name

Teva Investigational Site 181

City

Dnipropetrovsk

Country

Ukraine

Facility Name

Teva Investigational Site 872

City

Donetsk

Country

Ukraine

Facility Name

Teva Investigational Site 282

City

Kharkiv

Country

Ukraine

Facility Name

Teva Investigational Site 281

City

Kiev

Country

Ukraine

Facility Name

Teva Investigational Site 180

City

Lugansk

Country

Ukraine

Facility Name

Teva Investigational Site 873

City

Lviv

Country

Ukraine

Facility Name

Teva Investigational Site 875

City

Odessa

Country

Ukraine

Facility Name

Teva Investigational Site 183

City

Poltava

Country

Ukraine

Facility Name

Teva Investigational Site 871

City

s. Oleksandrivka

Country

Ukraine

Facility Name

Teva Investigational Site 182

City

Vinnytsya

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

26330288

Citation

Frye MA, Amchin J, Bauer M, Adler C, Yang R, Ketter TA. Randomized, placebo-controlled, adjunctive study of armodafinil for bipolar I depression: implications of novel drug design and heterogeneity of concurrent bipolar maintenance treatments. Int J Bipolar Disord. 2015 Dec;3(1):34. doi: 10.1186/s40345-015-0034-0. Epub 2015 Sep 2.

Results Reference

derived

Learn more about this trial

Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

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Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Depression

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial