CTRI/2010/091/001249
Completed
Phase 2
A randomized double-blind comparison of fluoxetine augmentation by high and low dosage folic acid in patients with depressive episodes
This study was part of an MD thesis in Psychiatry0 sites42 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- This study was part of an MD thesis in Psychiatry
- Enrollment
- 42
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Out\-patients suffering from first/recurrent moderate/severe depressive episodes without psychotic symptoms diagnosed as per ICD\-10
- •2\. 16\-45 years of age
- •3\. Residing with in 15 Km radius from the National Institute of Mental Health and Neurosciences (NIMHANS)
- •4\. Written informed consent for participation
- •5\.Scores of at least 18 on Hamilton depressin rating scale(HDRS)
- •6\. Haemoglobin level of more than 10mg%, Mean corpuscular volume (MCV) not exceeding 100 fl, normal peripheral smear
- •7\. Drug free period of 8 weeks: For the purpose of this study, a patient who had received antidepressants, benzodiazepines or neuroleptics (non\-depot) for 4 days or less during the past 8 weeks were considered drug free
Exclusion Criteria
- •1\. Symptoms requiring alternate treatment viz: suicidal (score of atleast 3 on HDRS
- •2\. Contraindication to fluoxetine (acute gastritis, duodenal ulcer, severe reflux oesophagitis, intolerance or allergy to fluoxetine in previous episodes, history of non\-response to fluoxetine in previous depressive episodes)
- •3\. Psychiatric or physical co\-morbidity (as revealed by a detailed physical examination and baseline investigations)
Outcomes
Primary Outcomes
Not specified
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