A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder (MDD)
Phase 3
Completed
- Conditions
- Major Depressive Disorder
- Registration Number
- CTRI/2010/091/001491
- Lead Sponsor
- AstraZeneca AB
- 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. The anticipated number of patients proposed to be recruited from India is 46 and anticipated date of enrollment is 12NOV2010.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 940
Inclusion Criteria
- 1.Provision of signed and dated informed consent before initiation of any study-related procedures.
- 2.The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
- 3.Out-patient status at enrollment and randomization.
Exclusion Criteria
- 1.Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
- 2.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.
- 3.History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population.
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 to end of treatment Will be scored at weeks 8,9,10,12,14 and 16
- Secondary Outcome Measures
Name Time Method Changes in clinician-rated symptoms as assessed by MADRS, HAM-D, CGI-S, CGI-I and HAM-A 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 SIS Will be analysed at Weeks 8, 12 and 16. QIDS-SR-16 will also be measured at Week 10 Safety and tolerability Time consent signed (enrollment, 1-2 wk screening/washout period), during 8-wk prospective open-label period, during 8-wk randomized double-blind period, and during 2-wk follow up period. Unsolicited SAEs collected 30 days post last treatment.
Trial Locations
- Locations (6)
ADI Clinics
🇮🇳Hills,, India
Government Hospital for Mental Care
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
JSS Medical College and Hospital
🇮🇳Mysore, KARNATAKA, India
Mahendru Psychiatric Centre
🇮🇳Kanpur, India
Poly Clinic And Mental Health Care Centre
🇮🇳Pet,Guntur, India
Radianz Clinical Research Unit
🇮🇳K.K.Nagar,Madurai, India
ADI Clinics🇮🇳Hills,, India12.Dr. Shekhar Aluka ReddyPrincipal investigator9848059452drshekarreddy@gmail.com