A clinical trial to study the effects of TC-5214 2 - 8 mg drug in combination with Citalopram in Major Depressive Disorder patients.
- Conditions
- Health Condition 1: null- Major Depressive Episode
- Registration Number
- CTRI/2008/091/000197
- Lead Sponsor
- Targacept
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 270
1. Male or female subjects aged 18 to70 years
2. Diagnosis of major depressive disorder (MDD) according to DSM IV and confirmed via MINI diagnostic scale
3. No more than 1 prior antidepressant course of treatment before trial entry for the current episode of depression.
4. Able to give written informed consent.
5. MADRS score greater than 27.
6. CGI S score greater than or equal to 4.
7. No clinically significant abnormality on physical examination, vital signs, ECG or laboratory tests (biochemical, hematological, urinary) at screening. Screening may be extended to repeat any clinically significant laboratory value. Any clinically significant which can be medically justified, is stable and will not place the subject at undue risk maybe allowed after discussion and approval by the Targacept Medical Monitor.
8. 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.
1.Any co morbid psychiatric illness confirmed by MINI diagnostic scale, especially bipolar disorder, schizophrenia, dementia, or PTSD
2. Subjects with significant suicidal risk upon clinical assessment utilizing the M.I.N.I.
3. History of alcohol or drug abuse over the last 6 months
4. History of seizures or seizure disorders
5. Any other severe progressive and uncontrolled medical condition
6. For other controlled medical conditions, medication to be unchanged over the 2 months preceding screening, or else the subject will be excluded
7. Subjects with Glaucoma, Kidney Disease or Heart Disease
8. Known hypersensitivity to mecamylamine
9. Other investigational drug in previous 30 days
10. Screening QTcB or QTcF > 450 msec
11. Prior use of citalopram or escitalopram for the current episode of MDD
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HAMD-17 scoreTimepoint: 8 Weeks
- Secondary Outcome Measures
Name Time Method Anxiety Somatization factor score in HAM-D<br>Timepoint: 8 weeks;Clinical Global Impression Scale<br>Timepoint: 8 weeks;MADRS<br>Timepoint: 8 weeks;QIDS-SR<br>Timepoint: 8 weeks;Scores of Sheehan Disability Scale and Sheehan Irritability ScaleTimepoint: 8 weeks;Subject Global Improvement ScaleTimepoint: 8 weeks;The proportion of subjects assessed to be full responders or in remission and who have a MADRS score of less than 10 <br/ ><br>Timepoint: 8 weeks