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: Major Depressive Disorder, MDD, Depression

• Registration Number: CTRI/2010/091/001410
• Lead Sponsor: AstraZeneca

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 planned date of enrollment for India is 14MAY11 and they are expected to enroll 530 subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-15
• Last Update Posted: 2015-12-05

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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)	Will be scored at Weeks 8 (baseline), 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
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 tolerability	Will be collected during the whole study period. Unsolicited SAEs will be collected for 30 days post last study treatment

Trial Locations

Locations (24)

Abhaya Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Ashray Clinic; 🇮🇳 Cross, India

Brain Mind Behaviour Neurosciences Research Institute; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Brij Psychiatry Hospital & Muskaan Research Centre; 🇮🇳 Vadodara, GUJARAT, India

CSM University UP; 🇮🇳 Lucknow, UTTAR PRADESH, India

Deva Mental Health Care; 🇮🇳 B,27/70,MN,Badhal,, Kothi, India

Government Hospital For Mental Care; 🇮🇳 India

KMC Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Madras Medical College & Government General Hospital; 🇮🇳 ,-600, India

Mahendru Psychiatric Centre; 🇮🇳 117/40,Sarvodaya, Nagar,, India

Scroll for more (14 remaining)

Abhaya Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr. A. Jagadish

Principal investigator

080-26564586

a_jagadish@yahoo.com