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A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder, Depression

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

TC-5214

Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, MDD, Depression, Safety, add-on therapy

Eligibility Criteria

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

Inclusion Criteria:

Provision of signed and dated informed consent before initiation of any study-related procedures.
The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
Out-patient status at enrollment and randomization.

Exclusion Criteria:

Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TC-5214

Placebo

Arm Description

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID

Outcomes

Primary Outcome Measures

Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.

A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.

Secondary Outcome Measures

Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)

The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score at end of treatment (Week 16) was calculated. A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.

Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)

The percentage of patients with a MADRS total score of ≤8 at end of treatment (Week 16) was calculated. A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.

Early and Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 10, Week 12, Week 14, and End of Treatment (Week 16)

The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 10, Week 12, Week 14, and end of treatment (Week 16) was calculated. A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.

Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)

The percentage of patients with a ≥50% reduction from randomization (Week 8) in MADRS total score and a MADRS total score of ≤12 at Week 12, Week 14, and end of treatment (Week 16) was calculated. A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.

Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)

The percentage of patients with a MADRS total score of ≤8 at Week 12, Week 14, and end of treatment (Week 16)was calculated. A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.

Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score

A 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.

Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)

A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. Higher CGI-S scores indicate greater illness severity.

Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of "Very Much Improved" or "Much Improved" From Randomization (Week 8) to End of Treatment (Week 16)

A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.

Change in MADRS Total Score From Randomization (Week 8) to Week 9

Change in MADRS Total Score From Randomization (Week 8) to Week 10

Change in MADRS Total Score From Randomization (Week 8) to Week 12

Change in MADRS Total Score From Randomization (Week 8) to Week 14

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score

Sheehan Disability Scale (SDS) is 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 inter-correlated domains (school/work, social life, and family life/home responsibilities) and ranges from 0 (unimpaired) to 30 (highly impaired).

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the work/school domain score is 0- 10, where 10 is considered to be 'highly impaired'.

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.

Change in Overall Quality of Life and Satisfaction From Randomization (Week 8) to End of Treatment (Week 16) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score

The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%.

Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15

The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 15th item queries respondents' satisfaction with the medication they are taking, rated on a 1 to 4 scale, score 0 indicates that no medication was taken. Higher scores are indicative of greater satisfaction.

Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16

The Q-LES-Q-SF (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form) measures the patient's satisfaction with medication and overall quality of life. The 16th item is a global rating of overall life satisfaction and contentment, rated on a 1 to 5 scale. Higher scores are indicative of greater satisfaction.

Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)

A self-assessment questionnaire that provides 2 measures of health status. The EQ-5D index score is a weighted linear combination over 5 dimensions of health status. The score for each of the 5 dimensions can range from 1 to 3, and an equation is used to calculate the EQ-5D index score. The EQ-5D index score can range from possible negative values (minimum -0.415) to a maximum of 1.0. The EQ-VAS is a visual analog scale with a range of 0 to 100. For both variables, a higher score indicates a better health state.

Full Information

NCT ID

NCT01180400

First Posted

August 5, 2010

Last Updated

March 14, 2014

Sponsor

AstraZeneca

Collaborators

Targacept Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01180400

Brief Title

A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

Official Title

A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Targacept Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

Detailed Description

A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

6. Conditions and Keywords

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

Major Depressive Disorder, Depression

Keywords

Major Depressive Disorder, MDD, Depression, Safety, add-on therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

295 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TC-5214

Arm Type

Experimental

Arm Description

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID

Intervention Type

Drug

Intervention Name(s)

TC-5214

Intervention Description

Tablet, oral, twice daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Tablet, oral, twice daily for 8 weeks

Primary Outcome Measure Information:

Title

Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment.

Description

Time Frame

Randomization (Week 8) to end of treatment (Week 16)

Secondary Outcome Measure Information:

Title

Response in Depressive Symptoms of Major Depressive Disorder (MDD), Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score at End of Treatment (Week 16)

Description

Time Frame

Randomization (Week 8) to end of treatment (Week 16)

Title

Remission in Depressive Symptoms of MDD, Defined as MADRS Total Score of ≤8 at End of Treatment (Week 16)

Description

Time Frame

Week 16

Title

Description

Time Frame

Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16

Title

Sustained Response, Defined as a ≥50% Reduction From Randomization (Week 8) in MADRS Total Score and a MADRS Total Score of ≤12 at Week 12, Week 14, and End of Treatment (Week 16)

Description

Time Frame

Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16

Title

Sustained Remission, Defined as a MADRS Total Score of ≤8 at Week 12, Week 14, and End of Treatment (Week 16)

Description

Time Frame

Week 12, Week 14, Week 16

Title

Change in Depressive Symptoms From Randomization (Week 8) to End of Treatment (Week 16) as Measured by Hamilton Rating Scale for Depression-17 Items (HAMD-17) Total Score

Description

Time Frame

Randomization (Week 8) to end of treatment (Week 16)

Title

Change in the Clinician-rated Global Outcome of Severity as Measured by the Clinical Global Impression-Severity (CGI-S) Score From Randomization (Week 8) to End of Treatment (Week 16)

Description

Time Frame

Randomization (Week 8) to end of treatment (Week 16)

Title

Response in the Clinical Global Impression-Improvement (CGI-I) Defined as CGI-I Rating of "Very Much Improved" or "Much Improved" From Randomization (Week 8) to End of Treatment (Week 16)

Description

Time Frame

Randomization (Week 8) to end of treatment (Week 16)

Title

Change in MADRS Total Score From Randomization (Week 8) to Week 9

Description

Time Frame

Randomization (Week 8) to Week 9

Title

Change in MADRS Total Score From Randomization (Week 8) to Week 10

Description

Time Frame

Randomization (Week 8) to Week 10

Title

Change in MADRS Total Score From Randomization (Week 8) to Week 12

Description

Time Frame

Randomization (Week 8) to Week 12

Title

Change in MADRS Total Score From Randomization (Week 8) to Week 14

Description

Time Frame

Randomization (Week 8) to Week 14

Title

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by the Sheehan Disability Scale (SDS) Total Score

Description

Time Frame

Randomization (Week 8) to end of treatment (Week 16)

Title

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Work/School Domain Score

Description

Time Frame

Randomization (Week 8) to end of treatment (Week 16)

Title

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Social Life Domain Score

Description

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS social life domain score is 0- 10, where 10 is considered to be 'highly impaired'.

Time Frame

Randomization (Week 8) to end of treatment (Week 16)

Title

Change in Functional Impairment From Randomization (Week 8) to End of Treatment (Week 16) as Measured by SDS Family Life/Home Responsibilities Domain Score

Description

A 5-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The 3 inter-correlated domains are school/work, social life, and family life/home responsibilities. The numerical rating for the SDS family life/home responsibilities domain score is 0- 10, where 10 is considered to be 'highly impaired'.

Time Frame

Randomization (Week 8) to end of treatment (Week 16)

Title

Description

Time Frame

Randomization (Week 8) to end of treatment (Week 16)

Title

Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 15

Description

Time Frame

Randomization (Week 8) to end of treatment (Week 16)

Title

Change From Randomization (Week 8) to End of Treatment (Week 16) in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q LES-Q-SF) Item 16

Description

Time Frame

Randomization (Week 8) to end of treatment (Week 16)

Title

Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 8) to End of Treatment (Week 16)

Description

Time Frame

Randomization (Week 8) to end of treatment (Week 16)

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: Provision of signed and dated informed consent before initiation of any study-related procedures. The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant. Out-patient status at enrollment and randomization. Exclusion Criteria: Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder. Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide. History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans A. Eriksson, MD, Ph.D, MBA

Organizational Affiliation

AstraZeneca R&D

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

D. Naber, Professor Dr.

Organizational Affiliation

University Hospital Hamburg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Brno

Country

Czech Republic

Facility Name

Research Site

City

Kutna Hora

Country

Czech Republic

Facility Name

Research Site

City

Litomerice

Country

Czech Republic

Facility Name

Research Site

City

Plzen

Country

Czech Republic

Facility Name

Research Site

City

Praha 10 - Strasnice

Country

Czech Republic

Facility Name

Research Site

City

Praha 10

Country

Czech Republic

Facility Name

Research Site

City

Praha 2

Country

Czech Republic

Facility Name

Research Site

City

Praha 5

Country

Czech Republic

Facility Name

Research Site

City

Praha 6

Country

Czech Republic

Facility Name

Research Site

City

Praha 8

Country

Czech Republic

Facility Name

Research Site

City

Praha 9

Country

Czech Republic

Facility Name

Research Site

City

Dublin

Country

Estonia

Facility Name

Research Site

City

Tallinn

Country

Estonia

Facility Name

Research Site

City

Tallin

Country

Estonia

Facility Name

Research Site

City

Tartu

Country

Estonia

Facility Name

Research Site

City

Voru

Country

Estonia

Facility Name

Research Site

City

Dublin

Country

Finland

Facility Name

Research Site

City

Espoo

Country

Finland

Facility Name

Research Site

City

Helsinki

Country

Finland

Facility Name

Research Site

City

Kuopio

Country

Finland

Facility Name

Research Site

City

Mikkeli

Country

Finland

Facility Name

Research Site

City

Oulu

Country

Finland

Facility Name

Research Site

City

Tampere

Country

Finland

Facility Name

Research Site

City

Toulon

State/Province

La Seyne Sur Mer

Country

France

Facility Name

Research Site

City

Douai

Country

France

Facility Name

Research Site

City

Dublin

Country

France

Facility Name

Research Site

City

Elancourt

Country

France

Facility Name

Research Site

City

Jarnac

Country

France

Facility Name

Research Site

City

La Seyne Sur Mer

Country

France

Facility Name

Research Site

City

Nimes Cedex 9

Country

France

Facility Name

Research Site

City

Rennes

Country

France

Facility Name

Research Site

City

Toulon

Country

France

Facility Name

Research Site

City

Villejuif

Country

France

Facility Name

Research Site

City

Mainz

State/Province

Country

Germany

Facility Name

Research Site

City

Berlin

Country

Germany

Facility Name

Research Site

City

Bochum

Country

Germany

Facility Name

Research Site

City

Dublin

Country

Germany

Facility Name

Research Site

City

Siegen

Country

Germany

Facility Name

Research Site

City

Dublin

Country

Hungary

Facility Name

Research Site

City

Dublin

Country

Latvia

Facility Name

Research Site

City

Jelgava

Country

Latvia

Facility Name

Research Site

City

Liepaja

Country

Latvia

Facility Name

Research Site

City

Riga

Country

Latvia

Facility Name

Research Site

City

Sigulda

Country

Latvia

Facility Name

Research Site

City

Strenci

Country

Latvia

Facility Name

Research Site

City

Ziegzdrai

State/Province

Kaunas

Country

Lithuania

Facility Name

Research Site

City

Dublin

Country

Lithuania

Facility Name

Research Site

City

Kaunas

Country

Lithuania

Facility Name

Research Site

City

Palanga

Country

Lithuania

Facility Name

Research Site

City

Silute

Country

Lithuania

Facility Name

Research Site

City

Vilnius

Country

Lithuania

Facility Name

Research Site

City

Belchatow

Country

Poland

Facility Name

Research Site

City

Bialystok

Country

Poland

Facility Name

Research Site

City

Bydgoszczy

Country

Poland

Facility Name

Research Site

City

Dublin

Country

Poland

Facility Name

Research Site

City

Gdansk

Country

Poland

Facility Name

Research Site

City

Gdynia

Country

Poland

Facility Name

Research Site

City

Leszno

Country

Poland

Facility Name

Research Site

City

Lublin

Country

Poland

Facility Name

Research Site

City

Sosnowiec

Country

Poland

Facility Name

Research Site

City

Torun

Country

Poland

Facility Name

Research Site

City

Toru

Country

Poland

Facility Name

Research Site

City

Zuromin

Country

Poland

Facility Name

Research Site

City

Dublin

Country

Sweden

Facility Name

Research Site

City

Goteborg

Country

Sweden

Facility Name

Research Site

City

Halmstad

Country

Sweden

Facility Name

Research Site

City

Lund

Country

Sweden

Facility Name

Research Site

City

Malmo

Country

Sweden

Facility Name

Research Site

City

Solna

Country

Sweden

Facility Name

Research Site

City

Stockholm

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

24507016

Citation

Vieta E, Thase ME, Naber D, D'Souza B, Rancans E, Lepola U, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Efficacy and tolerability of flexibly-dosed adjunct TC-5214 (dexmecamylamine) in patients with major depressive disorder and inadequate response to prior antidepressant. Eur Neuropsychopharmacol. 2014 Apr;24(4):564-74. doi: 10.1016/j.euroneuro.2013.12.008. Epub 2013 Dec 21.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1412&filename=CSR-D4130C00003.pdf

Description

CSR-D4130C00003.pdf

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1412&filename=D4130C00003_Revised_CSP_1_REDACTED.PDF

Description

D4130C00003/Clinical Study Protocol

Learn more about this trial

A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

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A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder

Major Depressive 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