A study to asses the efficacy and safety of TC-5214 as an adjunct therapy in patients with major depressive disorder.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Major Depressive Disorder, MDD, Depression
- Registration Number
- CTRI/2010/091/001410
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2236
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 signficant history of risk of suicide or homicide.
- History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from randomization (Week 8) to end of treatment (Week 16)Timepoint: Will be scored at Weeks 8 (baseline), 9, 10, 12, 14, and 16
- Secondary Outcome Measures
Name Time Method AEs, SAEs, change in physical exam results and vital signs, laboratory tests and ECG, C-SSRS, BARS and AIMS, CSFQ, and DESS will be assessed as a measure of safety and tolerabilityTimepoint: Will be collected during the whole study period. Unsolicited SAEs will be collected for 30 days post last study treatment;Changes in clinician-rated symptoms as assessed by MADRS, HAM-D, CGI-S, CGI-I and HAM-ATimepoint: MADRS and CGI will be scored at Weeks 8 (baseline), 9, 10, 12, 14, and 16; HAM-D and HAM-A will be scored at Weeks 8 (baseline) and 16;Changes in patient-reported outcomes as assessed by SDS, Q-LES-Q-SF, QIDS-SR-16 and SISTimepoint: Will be analysed at Weeks 8, 12 and 16. QIDS-SR-16 will also be measured at Week 10