A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Registration Number
- CTRI/2012/06/002750
- 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
- Completed
- Sex
- All
- Target Recruitment
- 352
- 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.
- 4.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.
- 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 (Week 8) to end of treatment (Week 16) Change in the Montgomery Asberg Depression Rating Scale (MADRS) total score from randomization (Week 8) to end of treatment (Week 16)
- Secondary Outcome Measures
Name Time Method Changes in clinician rated symptoms as assessed by Montgomery Asberg Depression Rating Scale (MADRS) Range of weeks 8 (baseline) to 16
Trial Locations
- Locations (22)
Adhit Kiran Neuropsychiatric Centre
🇮🇳Bangalore, KARNATAKA, India
Ashray Clinic
🇮🇳Ahmadabad, GUJARAT, India
Deenanath Mangeshkar Hospital & Research centre
🇮🇳Pune, MAHARASHTRA, India
Department of Psychiatry, Kasturba Medical College Hospital (KMC Hospital)
🇮🇳Bangalore, KARNATAKA, India
Deva Institute of Health care & Research
🇮🇳Varanasi, UTTAR PRADESH, India
Government Hospital For Mental Care
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Gujarat Institute of Psychological Sciences and Research Center (GIPS)
🇮🇳Ahmadabad, GUJARAT, India
Hatkesh Health Foundation
🇮🇳Junagadh, GUJARAT, India
JSS Medical College and Hospital
🇮🇳Mysore, KARNATAKA, India
Mahendru Psychiatric Centre
🇮🇳Nagar, UTTAR PRADESH, India
Scroll for more (12 remaining)Adhit Kiran Neuropsychiatric Centre🇮🇳Bangalore, KARNATAKA, IndiaDr PK Kiran KumarPrincipal investigator919845308734drkirana@hotmail.com