A clinical trial to study the efficacy of two different doses of folic acid as an augmenting agent with antidepresant drug fluoxetine in patients with depressive episodes

Phase 2

Completed

• Conditions: Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic featuresHealth Condition 2: F331- Major depressive disorder, recurrent, moderateHealth Condition 3: F321- Major depressive disorder, singleepisode, moderateHealth Condition 4: F322- Major depressive disorder, singleepisode, severe without psychotic features

• Registration Number: CTRI/2010/091/001249
• Lead Sponsor: This study was part of an MD thesis in Psychiatry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 42

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scores on HDRS and Beck depression inventory (BDI)Timepoint: Days 0,7,14, 21, 28, 35 and 42

Secondary Outcome Measures

Name	Time	Method
ILTimepoint: NI