TC-5214 as add-on the Treatment of Major Depressive Disorder
Completed · Phase 2 · Has a placebo group
Conditions studied: Major Depressive Disorder, Depression
In brief
This is a multi-center, double blind, randomized, placebo-controlled, parallel group, flexible dose titration study conducted in centers in the USA and India. Following a washout period, subject will be treated with citalopram 20 mg once daily for 4 weeks, then with 40 mg once daily for 4 weeks. Subjects who tolerate 40 mg citalopram, but whose MADRS score is \< 50% from baseline, but no lower than 17, will be considered partial or non-responders and will be randomized to receive either placebo or TC-5214 as add-on therapy. TC-5214 or placebo will be started at 2 mg daily (BID dosing), and be titrated based on tolerability and therapeutic response up to 8 mg daily. Approximately 560 subjects will enter the Open Label Phase and approximately 220 will enter the double blind phase of the study.
Key facts
- Study ID
- NCT00692445
- Run by
- Targacept Inc.
- People needed
- 574
- Starts
- 2008-06-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2013-06-21
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of major depressive disorder (MDD) according to DSM-IV and confirmed via MINI diagnostic scale
- No more than 1 prior antidepressant course of treatment before trial entry.
- Able to give written informed consent.
- MADRS score greater than 27.
- CGI-S score greater than or equal to 4.
- No clinically significant abnormality on physical examination, vital signs, ECG or laboratory tests at screening.
- Women of child bearing potential must: a) have a negative urine pregnancy test, b) not be nursing, and c) be willing to use acceptable methods of contraception throughout the study period.
You may not qualify if…
- Any co morbid psychiatric illness confirmed by MINI diagnostic scale, especially bipolar disorder, schizophrenia, dementia, or PTSD
- Subjects with significant suicidal risk upon clinical assessment utilizing the M.I.N.I.
- History of alcohol or drug abuse over the last 6 months
- History of seizures or seizure disorders
- Any other severe progressive and uncontrolled medical condition
- For other controlled medical conditions, medication to be unchanged over the 2 months preceding screening, or else the subject will be excluded
- Subjects with Glaucoma, Kidney Disease or Heart Disease
- Known hypersensitivity to mecamylamine
- Other investigational drug in previous 30 days
- Screening QTcB or QTcF > 450 msec
- Current or prior citalopram treatment
Where it is running
- M.S. Chellamuthu Trust & Research Foundation — Madurai, Tamil Nadu, India
- Mahendru Psychiatric Centre — Kanpur, Uttar Pradesh, India
- C.S.M. Medical University, Department of Psychiatry — Lucknow, Uttar Pradesh, India
- Aurora Clinical Trials — Miami, Florida, United States
- Community Research — Cincinnati, Ohio, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
- Sravani Poly Clinic and Mental Health — Guntur, Andhra Pradesh, India
- Asha Hospital — Hyderabaad, Andhra Pradesh, India
- Brain Mind Behaviour Neuroscience Research Institute — Maharanipet, Andhra Pradesh, India
- VIMHANS — Vijaywada, Andhra Pradesh, India
- Government Hospital for Mental Care, Dept. of Psychiatry — Visakhapatnam, Andhra Pradesh, India
- SV Medical College — Tirupati, Chittoor District, Andhra Pradesh, India
- Sri Kishna Prasad Psychiatric Nursing Home — Ahmedabad, Gujarat, India
- Victoria Hospital, Dept. of Psychiatry — Bangalore, Karnataka, India
- St. John's Hospital — Bangalore, Karnataka, India
- Adhit Kiran Neuro Psychiatric Centre — Mangalore, Karnataka, India
- JSS Medical College Hospital, Dept. of Psychiatry — Mysore, Karnataka, India
- Bhopal Memorial Hospital & Research Centre, Dept. of Psychiatry — Bhopal, Madhya Pradesh, India
- Holy Family Hospital — Mumbai, Maharashtra, India
- Deenanath Maneshkas Hospital — Pune, Maharashtra, India
- Sanjeevan Hospital — Pune, Maharashtra, India
- Poona Hospital & Research Centre — Pune, Maharashtra, India
- GB pant Hospital — Indraprastha, National Capital Territory of Delhi, India
- AIIMS — New Dehli, National Capital Territory of Delhi, India
- Bhora Nuro Psychiatric Centre — New Delhi, National Capital Territory of Delhi, India
Full record on ClinicalTrials.gov
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