Status:
COMPLETED
TC-5214 as add-on the Treatment of Major Depressive Disorder
Lead Sponsor:
Targacept Inc.
Conditions:
Major Depressive Disorder
Depression
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
574 Patients enrolled
Trial Details
Trial ID
NCT00692445
Start Date
June 1 2008
End Date
July 1 2009
Last Update
June 21 2013
Active Locations (27)
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1
Aurora Clinical Trials
Miami, Florida, United States, 33143
2
Community Research
Cincinnati, Ohio, United States, 45227
3
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
4
Sravani Poly Clinic and Mental Health
Guntur, Andhra Pradesh, India, Guntur-522001