Back to results

Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study

Primary Purpose

Bipolar Disorder, Depressive Episode

Status

Terminated

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Low dose Adjunctive Aripiprazole

placebo

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

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

Inclusion Criteria:

Age : 18-65
Male or female
Bipolar Disorder type I
Current depressive episode (with MADRS ≥ 20 and item 2 (reported sadness) ≥ 3) for a minimum of 2 weeks but ≤ 52 weeks at screening visit and baseline visit)
If female and of childbearing potential, is using an adequate method of contraception.
Is treated with a mood stabilizer (lithium and/or valproate)
Patient is able to give his consent

Exclusion Criteria:

Is at high risk of suicide as defined by a score of ≥ 3 to item 10 of MADRS and/or in the clinical opinion of the investigator
Hypo(mania) episode with YMRS ≥ 8
Psychotic symptoms as defined by a score of ≥ 4 to item 8 (content) of YMRS and/or in the opinion of the investigator
Is treated with fluoxetine OR lamotrigine OR carbamazepine OR any antidepressants
Is treated with risperidone OR olanzapine OR quetiapine OR ziprazidone OR any antipsychotics
Is pregnant or lactating or absence of contraceptive treatment
Drug abuse or dependence as per DSM-IV (MINI)
Unstable medical condition
Other psychiatric condition, organic brain disorder, unstable and/or untreated medical condition such as hypothyroidism, hyperthyroidism, diabetes, cardiac condition, hypertension
Deficit in vitamin B12 or folate
Alcohol or drug abuse
Rapid cycling (more than 4 mood episodes per year)
Active or history of difficulty to swallow
Seizures not currently controlled with medications
Orthostatic hypotension
A history of clinically significant cardiovascular disorders and cardiac arrhythmias
A low white blood cell count
Known eye disease
Involuntary, irregular muscle movements, especially in the face
Known hypersensitivity to aripiprazole and any components of its formulation
Known lactose intolerance or have hereditary galactose intolerance or glucose-galactose malabsorption, because ABILIFY tablets contain lactose

Sites / Locations

Douglas Mental Health University Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mood stabilizer + Aripiprazole

Mood stabilizer + placebo

Arm Description

Outcomes

Primary Outcome Measures

Response rate

The primary outcome measure will be the response rate as defined by a differential reduction of 5 points on the Montgomery Asberg rating Scale (MADRS) between the active treatment group and the placebo group at 8 weeks of treatment.

Secondary Outcome Measures

Full Information

NCT ID

NCT01520350

First Posted

January 25, 2012

Last Updated

July 28, 2014

Sponsor

Serge Beaulieu

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01520350

Brief Title

Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study

Official Title

Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Terminated

Why Stopped

recruitment issues

Study Start Date

February 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Serge Beaulieu

Collaborators

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Aripiprazole is a new antipsychotic agent which possesses unique capabilities compared to other antipsychotic agents, especially because of its partial dopaminergic agonistic activity. Moreover, like the other atypical agents, aripiprazole is an antagonist of the 5-HT2a receptor, and an agonist of the 5-HT1a receptor. These pharmacological properties should enable this molecule to provide antidepressant potentiating capabilities based on what has been observed with other compounds sharing similar pharmacological profiles. Aripiprazole is now well recognized for its capacity to potentiate antidepressants in the treatment of unipolar depression. However, two randomized controlled trials of aripiprazole in the treatment of bipolar depression were negative. This surprising result may stem from the fact that the doses of aripiprazole used in these studies were rather high (17.6 ± 8.3 mg/d in study 1 and 15.5 ± 7.5 mg/d in study 2) and could have contributed to inhibit dopaminergic activity in key brain areas involved in the modulation of rewards, motivation and concentration. Bipolar depression is indeed heavily loaded with general symptoms of psychomotor retardation including poor concentration, low energy level, hypersomnolence, and hyperphagia. All these functions are modulated by dopamine and strategies aimed at improving dopaminergic function are used frequently to resolve residual symptoms of bipolar depression. It is expected that aripiprazole used at a more adequate lower dose than in previous studies, should be efficacious in the treatment of bipolar type I depression.

6. Conditions and Keywords

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

Bipolar Disorder, Depressive Episode

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mood stabilizer + Aripiprazole

Arm Type

Experimental

Arm Title

Mood stabilizer + placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Low dose Adjunctive Aripiprazole

Other Intervention Name(s)

Abilify

Intervention Description

low-dose 2-5mg/d for 8 weeks

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Response rate

Description

Time Frame

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: Age : 18-65 Male or female Bipolar Disorder type I Current depressive episode (with MADRS ≥ 20 and item 2 (reported sadness) ≥ 3) for a minimum of 2 weeks but ≤ 52 weeks at screening visit and baseline visit) If female and of childbearing potential, is using an adequate method of contraception. Is treated with a mood stabilizer (lithium and/or valproate) Patient is able to give his consent Exclusion Criteria: Is at high risk of suicide as defined by a score of ≥ 3 to item 10 of MADRS and/or in the clinical opinion of the investigator Hypo(mania) episode with YMRS ≥ 8 Psychotic symptoms as defined by a score of ≥ 4 to item 8 (content) of YMRS and/or in the opinion of the investigator Is treated with fluoxetine OR lamotrigine OR carbamazepine OR any antidepressants Is treated with risperidone OR olanzapine OR quetiapine OR ziprazidone OR any antipsychotics Is pregnant or lactating or absence of contraceptive treatment Drug abuse or dependence as per DSM-IV (MINI) Unstable medical condition Other psychiatric condition, organic brain disorder, unstable and/or untreated medical condition such as hypothyroidism, hyperthyroidism, diabetes, cardiac condition, hypertension Deficit in vitamin B12 or folate Alcohol or drug abuse Rapid cycling (more than 4 mood episodes per year) Active or history of difficulty to swallow Seizures not currently controlled with medications Orthostatic hypotension A history of clinically significant cardiovascular disorders and cardiac arrhythmias A low white blood cell count Known eye disease Involuntary, irregular muscle movements, especially in the face Known hypersensitivity to aripiprazole and any components of its formulation Known lactose intolerance or have hereditary galactose intolerance or glucose-galactose malabsorption, because ABILIFY tablets contain lactose

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Serge Beaulieu, MD, PhD

Organizational Affiliation

Douglas Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Douglas Mental Health University Institute

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H4H 1R3

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Low-Dose Adjunctive Aripiprazole in the Treatment of Bipolar Depression: Double-Blind Placebo-Controlled Pilot Study

We'll reach out to this number within 24 hrs