Depression Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III, Long-Term Safety and Tolerability Study of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit 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 for 52 weeks with another antidepressant medicine.
Status | Completed |
Enrollment | 813 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
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. - 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. - Patients with significant liver, kidney, lung, heart, neurological, or any other medical conditions that might confound the study or put the patient at greater risk during study participation. |
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 |
---|---|---|---|
Puerto Rico | Research Site | San Juan | |
United States | Research Site | Albuquerque | New Mexico |
United States | Research Site | Arcadia | California |
United States | Research Site | Austin | Texas |
United States | Research Site | Baltimore | Maryland |
United States | Research Site | Beechwood | Ohio |
United States | Research Site | Beverly Hills | California |
United States | Research Site | Birmingham | Alabama |
United States | Research Site | Bradenton | Florida |
United States | Research Site | Canton | Ohio |
United States | Research Site | Carson | California |
United States | Research Site | Cerritos | California |
United States | Research Site | Charleston | South Carolina |
United States | Research Site | Charlotte | North Carolina |
United States | Research Site | Chicago | Illinois |
United States | Research Site | Chino | California |
United States | Research Site | Coral Springs | Florida |
United States | Research Site | Costa Mesa | California |
United States | Research Site | Creve Coeur | Missouri |
United States | Research Site | Dallas | Texas |
United States | Research Site | Dayton | Ohio |
United States | Research Site | Denver | Colorado |
United States | Research Site | Dublin | Ohio |
United States | Research Site | Encino | California |
United States | Research Site | Escondido | California |
United States | Research Site | Florence | Kentucky |
United States | Research Site | Flowood | Mississippi |
United States | Research Site | Fresh Meadows | New York |
United States | Research Site | Friendswood | Texas |
United States | Research Site | Ft Myers | Florida |
United States | Research Site | Gainsville | Florida |
United States | Research Site | Gaithersburg | Maryland |
United States | Research Site | Garden Grove | California |
United States | Research Site | Glen Burnie | Maryland |
United States | Research Site | Hoffman Estates | Illinois |
United States | Research Site | Irvine | California |
United States | Research Site | Irving | Texas |
United States | Research Site | Jacksonville | Florida |
United States | Research Site | Jenkintown | Pennsylvania |
United States | Research Site | Joliet | Illinois |
United States | Research Site | Lafayette | Indiana |
United States | Research Site | Lake Jackson | Texas |
United States | Research Site | Lincoln | Nebraska |
United States | Research Site | Little Rock | Arkansas |
United States | Research Site | Los Alamitos | California |
United States | Research Site | Los Angeles | California |
United States | Research Site | Maitland | Florida |
United States | Research Site | Mason | Ohio |
United States | Research Site | Middleburg Heights | Ohio |
United States | Research Site | Middleton | Wisconsin |
United States | Research Site | Mount Kisco | New York |
United States | Research Site | New York | New York |
United States | Research Site | Newport Beach | California |
United States | Research Site | Norristown | Pennsylvania |
United States | Research Site | North Miami | Florida |
United States | Research Site | Norwalk | Connecticut |
United States | Research Site | Norwich | Connecticut |
United States | Research Site | Orange City | Florida |
United States | Research Site | Orlando | Florida |
United States | Research Site | Pico Rivera | California |
United States | Research Site | Pinecrest | Florida |
United States | Research Site | Pittsburgh | Pennsylvania |
United States | Research Site | Plantation | Florida |
United States | Research Site | Portland | Oregon |
United States | Research Site | Prairie Village | Kansas |
United States | Research Site | Riverside | California |
United States | Research Site | Rochester | New York |
United States | Research Site | Rockville | Maryland |
United States | Research Site | Roswell | Georgia |
United States | Research Site | Salem | Oregon |
United States | Research Site | San Antonio | Texas |
United States | Research Site | Schaumburg | Illinois |
United States | Research Site | Seattle | Washington |
United States | Research Site | Sherman Oaks | California |
United States | Research Site | Shreveport | Louisiana |
United States | Research Site | Skokie | Illinois |
United States | Research Site | South Kirkland | Washington |
United States | Research Site | St Petersburg | Florida |
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 | Toledo | Ohio |
United States | Research Site | Toms River | New Jersey |
United States | Research Site | Torrance | California |
United States | Research Site | Tucson | Arizona |
United States | Research Site | Tuscaloosa | Alabama |
United States | Research Site | Upland | California |
United States | Research Site | Valparaiso | Indiana |
United States | Research Site | West Palm Beach | Florida |
United States | Research Site | Weymouth | Massachusetts |
United States | Research Site | Wichita | Kansas |
United States | Research Site | Willingboro | New Jersey |
United States | Research Site | Wilmington | North Carolina |
United States | Research Site | Woodstock | Vermont |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca | Targacept Inc. |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of Patients Experiencing at Least One Adverse Event (AE) | The frequency of patients experiencing at least one AE during the randomized treatment or follow-up periods was calculated. | Randomization (Week 0) to end of the follow-up period (Week 54) | No |
Primary | Frequency of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP) | The frequency of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated. | Randomization (Week 0) to end of the follow-up period (Week 54) | No |
Primary | Frequency of Patients Experiencing Serious Adverse Events (SAEs) | The frequency of patients experiencing serious adverse events (SAEs) during the randomized treatment or follow-up periods was calculated. | Randomization (Week 0) to end of the follow-up period (Week 54) | No |
Secondary | Sustained Efficacy at 3 Months, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of =12 at Week 12 and All Visits up to and Including Week 24 | The percentage of patients with a a MADRS total score of =12 at Week 12 and all visits up to and including Week 24 was calculated. One intermediate occurrence of a MADRS total score >12 but =16 or missing was allowed from Week 16 to Week 20. 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. |
Week 12 to Week 24 | No |
Secondary | Sustained Efficacy at 9 Months, Defined as a MADRS Total Score of =12 at Week 12 and at All Visits up to and Including Week 52 | The percentage of patients with a MADRS total score of =12 at Week 12 and at all visits up to and including Week 52 was calculated. Two intermediate occurrences (not consecutive) of a MADRS >12 but =16 or missing were allowed from Week 16 to Week 48. 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. |
Week 12 to Week 52 | 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 0) to End of Treatment (Week 52) | 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 0) to end of treatment (Week 52) | No |
Secondary | Change in Functional Impairment From Randomization (Week 0) to End of Treatment (Week 52) 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 0) to end of treatment (Week 52) | No |
Secondary | Change in Overall Quality of Life and Satisfaction From Randomization (Week 0) to End of Treatment (Week 52) by Assessing the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) % Maximum Total Score | The Q-LES-Q-SF 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 0) to end of treatment (Week 52) | No |
Secondary | Change in EuroQol - 5 Dimensions (EQ-5D) From Randomization (Week 0) to End of Treatment (Week 52) | 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. | Randomization (Week 0) to end of treatment (Week 52) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A |