Depression Clinical Trial
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 With an Inadequate Response to Antidepressant Therapy
Verified date | March 2014 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 319 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Research Site | Ahmedabad | Gujarat |
India | Research Site | Aurangabad | Maharashtra |
India | Research Site | Guntur | Andhra Pradesh |
India | Research Site | Jaipur | Rajasthan |
India | Research Site | Kanpur | |
India | Research Site | Khatipura | Rajasthan |
India | Research Site | Madurai | Tamilnadu |
India | Research Site | Mangalore | Karnataka |
India | Research Site | Mysore | |
India | Research Site | Nashik | Mahara |
India | Research Site | Pune | Maharashtra |
India | Research Site | Rajkot | Gujrat |
India | Research Site | Varanasi | Uttar Prad |
India | Research Site | Visakhapatnam | Andh Prad |
United States | Research Site | Charleston | South Carolina |
United States | Research Site | Chicago | Illinois |
United States | Research Site | Chino | California |
United States | Research Site | Cincinnati | Ohio |
United States | Research Site | Coral Springs | Florida |
United States | Research Site | Costa Mesa | California |
United States | Research Site | Dallas | Texas |
United States | Research Site | Dayton | Ohio |
United States | Research Site | Encino | California |
United States | Research Site | Escondido | California |
United States | Research Site | Florence | Kentucky |
United States | Research Site | Hamden | Connecticut |
United States | Research Site | Houston | Texas |
United States | Research Site | Jacksonville | Florida |
United States | Research Site | Little Rock | Arkansas |
United States | Research Site | Los Alamitos | California |
United States | Research Site | Middleburg Heights | Ohio |
United States | Research Site | New York | New York |
United States | Research Site | Norristown | Pennsylvania |
United States | Research Site | Oceanside | California |
United States | Research Site | Orange City | Florida |
United States | Research Site | Orlando | Florida |
United States | Research Site | Pico Rivera | California |
United States | Research Site | Portland | Oregon |
United States | Research Site | Prairie Village | Kansas |
United States | Research Site | Rochester | New York |
United States | Research Site | Salem | Oregon |
United States | Research Site | San Diego | California |
United States | Research Site | Seattle | Washington |
United States | Research Site | Shreveport | Louisiana |
United States | Research Site | St. Louis | Missouri |
United States | Research Site | Staten Island | New York |
United States | Research Site | Tampa | Florida |
United States | Research Site | Torrance | California |
United States | Research Site | Tucson | Arizona |
United States | Research Site | Tuscaloosa | Alabama |
United States | Research Site | Woodstock | Vermont |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Targacept Inc. |
United States, India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Randomization (Week 8) to end of treatment (Week 16) | No |
Secondary | 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. |
Randomization (Week 8) to end of treatment (Week 16) | No |
Secondary | 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. |
Week 16 | No |
Secondary | 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. |
Randomization (Week 8) to end of treatment (Week 16); Week 10, Week 12, Week 14, and Week 16 | No |
Secondary | 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. |
Randomization (Week 8) to end of treatment (Week 16); Week 12, Week 14, and Week 16 | No |
Secondary | 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. |
Week 12, Week 14, Week 16 | No |
Secondary | 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. | Randomization (Week 8) to end of treatment (Week 16) | No |
Secondary | 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. | Randomization (Week 8) to end of treatment (Week 16) | No |
Secondary | 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. | Randomization (Week 8) to end of treatment (Week 16) | No |
Secondary | Change in MADRS Total Score From Randomization (Week 8) to Week 9 | 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. 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. |
Randomization (Week 8) to Week 9 | No |
Secondary | Change in MADRS Total Score From Randomization (Week 8) to Week 10 | 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. | Randomization (Week 8) to Week 10 | No |
Secondary | Change in MADRS Total Score From Randomization (Week 8) to Week 12 | 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. | Randomization (Week 8) to Week 12 | No |
Secondary | Change in MADRS Total Score From Randomization (Week 8) to Week 14 | 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. | Randomization (Week 8) to Week 14 | No |
Secondary | 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). | Randomization (Week 8) to end of treatment (Week 16) | No |
Secondary | 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'. | Randomization (Week 8) to end of treatment (Week 16) | No |
Secondary | 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'. | Randomization (Week 8) to end of treatment (Week 16) | No |
Secondary | 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'. | Randomization (Week 8) to end of treatment (Week 16) | No |
Secondary | 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%. | Randomization (Week 8) to end of treatment (Week 16) | No |
Secondary | 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. |
Randomization (Week 8) to end of treatment (Week 16) | No |
Secondary | 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. |
Randomization (Week 8) to end of treatment (Week 16) | No |
Secondary | Change in Irritability Symptoms as Measured by the Sheehan Irritability Scale (SIS) Total Score From Randomization (Week 8) to End of Treatment (Week 16) | A self-administered scale to be used by clinical subjects to rate suffering over the past week with regard to irritability symptoms. The total SIS score is the sum of 7 items, and ranges from 0 to 70. Each item is assessed on an 11-point scale where 0=not at all, 1-3=mildly, 4-6=moderately, 7-9=markedly, and 10=extremely. The SIS also records the number of days impaired by irritability. | Randomization (Week 8) to end of treatment (Week 16) | No |
Secondary | 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. | Randomization (Week 8) to end of treatment (Week 16) | No |
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