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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

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

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.
Outpatient 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 investigational product.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

0.1 mg BID TC-5214

1 mg BID TC-5214

4 mg BID TC-5214

Placebo

Arm Description

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID

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

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 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. MADRS is 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. MADRS is 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. MADRS is 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. MADRS is 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. MADRS is 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 Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)

A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale. Higher HAM-A scores indicate higher levels of anxiety.

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. Higher scores are indicative of greater enjoyment or satisfaction in each domain.

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. Higher scores are indicative of greater enjoyment or satisfaction in each domain.

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 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

NCT01197508

First Posted

September 8, 2010

Last Updated

March 14, 2014

Sponsor

AstraZeneca

Collaborators

Targacept Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01197508

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 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants 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

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Targacept Inc.

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a 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 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants 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

Keywords

Major Depressive Disorder, MDD, Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

696 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.1 mg BID TC-5214

Arm Type

Experimental

Arm Description

Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID

Arm Title

1 mg BID TC-5214

Arm Type

Experimental

Arm Description

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

Arm Title

4 mg BID TC-5214

Arm Type

Experimental

Arm Description

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

Twice daily for 8 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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 Hamilton Anxiety Scale (HAM-A) Total Score From Randomization (Week 8) to End of Treatment (Week 16)

Description

A 14-item clinician-administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 to 4 scale. Higher HAM-A scores indicate higher levels of anxiety.

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. Outpatient 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 investigational product.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans A Eriksson, MD,PhD, MBA

Organizational Affiliation

AstraZeneca R&D

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Hans-Jürgen Möller, Prof. Dr.

Organizational Affiliation

University Hospital München

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Buenos Aires

State/Province

Caba

Country

Argentina

Facility Name

Research Site

City

Ciudad Autonoma Bs As, Cba

Country

Argentina

Facility Name

Research Site

City

Dublin

Country

Argentina

Facility Name

Research Site

City

Mendoza

Country

Argentina

Facility Name

Research Site

City

Rio de Janeiro

Country

Brazil

Facility Name

Research Site

City

Novi Iskar

Country

Bulgaria

Facility Name

Research Site

City

Ruse

Country

Bulgaria

Facility Name

Research Site

City

Antofagasta

Country

Chile

Facility Name

Research Site

City

Providencia Santiago

Country

Chile

Facility Name

Research Site

City

Santiago

Country

Chile

Facility Name

Research Site

City

Bello

State/Province

Antioquia

Country

Colombia

Facility Name

Research Site

City

Bogota

State/Province

Cundinamarca

Country

Colombia

Facility Name

Research Site

City

Pereira

State/Province

Risaralda

Country

Colombia

Facility Name

Research Site

City

Cali

State/Province

Valle

Country

Colombia

Facility Name

Research Site

City

Rijeka

Country

Croatia

Facility Name

Research Site

City

Bully Les Mines

Country

France

Facility Name

Research Site

City

Caen

Country

France

Facility Name

Research Site

City

Cherbourg

Country

France

Facility Name

Research Site

City

Colmar Cedex

Country

France

Facility Name

Research Site

City

Dole Cedex

Country

France

Facility Name

Research Site

City

Douai

Country

France

Facility Name

Research Site

City

Elancourt

Country

France

Facility Name

Research Site

City

Montpellier

Country

France

Facility Name

Research Site

City

Sartrouville

Country

France

Facility Name

Research Site

City

Strasbourg

Country

France

Facility Name

Research Site

City

Toulon

Country

France

Facility Name

Research Site

City

Toulouse

Country

France

Facility Name

Research Site

City

Tours Cedex 9

Country

France

Facility Name

Research Site

City

Huttenberg

State/Province

Country

Germany

Facility Name

Research Site

City

Bad Homburg

Country

Germany

Facility Name

Research Site

City

Bielefeld

Country

Germany

Facility Name

Research Site

City

Gelsenkirchen

Country

Germany

Facility Name

Research Site

City

Schwerin

Country

Germany

Facility Name

Research Site

City

Siegen

Country

Germany

Facility Name

Research Site

City

Balassagyarmat

Country

Hungary

Facility Name

Research Site

City

Budapest

Country

Hungary

Facility Name

Research Site

City

Gyor

Country

Hungary

Facility Name

Research Site

City

Bialystok

Country

Poland

Facility Name

Research Site

City

Bydgoszcz

Country

Poland

Facility Name

Research Site

City

Leszno

Country

Poland

Facility Name

Research Site

City

Lublin

Country

Poland

Facility Name

Research Site

City

Torun

Country

Poland

Facility Name

Research Site

City

Arad

Country

Romania

Facility Name

Research Site

City

Brasov

Country

Romania

Facility Name

Research Site

City

Bucharest

Country

Romania

Facility Name

Research Site

City

Cluj-napoca

Country

Romania

Facility Name

Research Site

City

Focsani

Country

Romania

Facility Name

Research Site

City

Oradea

Country

Romania

Facility Name

Research Site

City

Timisoara

Country

Romania

Facility Name

Research Site

City

Arkhangelsk

Country

Russian Federation

Facility Name

Research Site

City

Chita

Country

Russian Federation

Facility Name

Research Site

City

Ekaterinburg

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

Country

Russian Federation

Facility Name

Research Site

City

Petrozavodsk

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

Country

Russian Federation

Facility Name

Research Site

City

Tomsk

Country

Russian Federation

Facility Name

Research Site

City

Voronezh

Country

Russian Federation

Facility Name

Research Site

City

Kragujevac

State/Province

Serbia and Montenegro

Country

Serbia

Facility Name

Research Site

City

NIS

Country

Serbia

Facility Name

Research Site

City

Banska Stiavnica

Country

Slovakia

Facility Name

Research Site

City

Bratislava

Country

Slovakia

Facility Name

Research Site

City

Levice

Country

Slovakia

Facility Name

Research Site

City

Presov

Country

Slovakia

Facility Name

Research Site

City

Rimavska Sobota

Country

Slovakia

Facility Name

Research Site

City

Svidnik

Country

Slovakia

Facility Name

Research Site

City

Trencin

Country

Slovakia

Facility Name

Research Site

City

Bloemfontein

State/Province

Free State

Country

South Africa

Facility Name

Research Site

City

Vereeniging

State/Province

Free State

Country

South Africa

Facility Name

Research Site

City

Cape Town

State/Province

Western Cape

Country

South Africa

Facility Name

Research Site

City

Centurion

Country

South Africa

Facility Name

Research Site

City

Durban

Country

South Africa

Facility Name

Research Site

City

George

Country

South Africa

Facility Name

Research Site

City

Paarl

Country

South Africa

Facility Name

Research Site

City

Port Elizabeth

Country

South Africa

Facility Name

Research Site

City

Sama de Langreo

State/Province

Asturias

Country

Spain

Facility Name

Research Site

City

Alcala de Henares

State/Province

Madrid

Country

Spain

Facility Name

Research Site

City

Coslada

State/Province

Madrid

Country

Spain

Facility Name

Research Site

City

Dnipropetrovsk

Country

Ukraine

Facility Name

Research Site

City

Donetsk

Country

Ukraine

Facility Name

Research Site

City

Kharkov

Country

Ukraine

Facility Name

Research Site

City

Kherson

Country

Ukraine

Facility Name

Research Site

City

Kiev

Country

Ukraine

Facility Name

Research Site

City

Lviv

Country

Ukraine

Facility Name

Research Site

City

Poltava

Country

Ukraine

Facility Name

Research Site

City

Simferpool

Country

Ukraine

Facility Name

Research Site

City

Ternopil

Country

Ukraine

Facility Name

Research Site

City

Vinnytsya

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

25602163

Citation

Moller HJ, Demyttenaere K, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Two Phase III randomised double-blind studies of fixed-dose TC-5214 (dexmecamylamine) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to prior antidepressant therapy. World J Biol Psychiatry. 2015 Oct;16(7):483-501. doi: 10.3109/15622975.2014.989261. Epub 2015 Jan 20.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=336&filename=CSR-D4130C00005.pdf

Description

CSR-D4130C00005.pdf

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=336&filename=D4130C00005_Revised_CSP_1_redacted.pdf

Description

D4130C00005/Clinical Study Protocol

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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.

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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

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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

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