A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.
- Conditions
- Major Depressive Disorder
- Registration Number
- CTRI/2011/10/002065
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 1152
- 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.
- Women of child-bearing potential must have a negative urine pregnancy test and confirmed use of a highly effective form of birth control before enrollment and until 3 months after their last dose of study drug.
- Outpatient status at enrollment and randomization.
- 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 any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
- History of stroke or transient ischemic attack, seizures or seizure disorder, head trauma including closed head injury.
- Pregnancy or lactation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in clinician rated symptoms as assessed by Clinical Global Impression-Improvement (CGI-I) Range of weeks 8 (baseline) to 16.
- Secondary Outcome Measures
Name Time Method Changes in clinician rated symptoms as assessed by MADRS Range of weeks 8 (baseline) to 16 Adverse Events (AEs)(any incidence) and Serious Adverse Events (SAEs), will be assessed as a measure of safety and tolerability. Range of weeks 8 (baseline) to 16. Change in physical exam results, vital signs, lab tests (incl. ECG (electrocardiogram) will be assessed. Range of weeks 1-18 Changes in clinician rated symptoms as assessed by Clinical Global Impression-Severity (CGI-S) Range of weeks 8 (baseline) to 16. Changes in patient-reported outcomes as assessed by Sheehan Disability Scale (SDS) Range of weeks 8 (baseline) to 16. Changes in clinician rated symptoms as assessed by Hamilton Rating Scale for Depression (HAMD). Range of weeks 8 (baseline) to 16
Trial Locations
- Locations (13)
Mental Illness Treatment Rehabilitation Foundation (MITR)
🇮🇳Ahmadabad, GUJARAT, India
Abhaya Hospital
🇮🇳Bangalore, KARNATAKA, India
Deenanath Mangeshkar Hospital & Research centre
🇮🇳Pune, MAHARASHTRA, India
Deva Institute of Health care & Research Pvt. Ltd
🇮🇳Varanasi, UTTAR PRADESH, India
Dr. Hitendra Gandhi
🇮🇳Ahmadabad, GUJARAT, India
Government Hospital For Mental Care
🇮🇳Kameng, ARUNACHAL PRADESH, India
Madras Medical College and Government General Hospital
🇮🇳Chennai, TAMIL NADU, India
Mahendru Psychiatric Centre
🇮🇳Nagar, UTTAR PRADESH, India
Manaswini, Thunga Institute of Psychiatry and Counselling
🇮🇳Bangalore, KARNATAKA, India
Mental Health care & Research
🇮🇳Jaipur, RAJASTHAN, India
Scroll for more (3 remaining)Mental Illness Treatment Rehabilitation Foundation (MITR)🇮🇳Ahmadabad, GUJARAT, IndiaMahesh ChudgarPrincipal investigator9825412109mahesh_mitr@yahoo.co.in