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

INTERVENTION: Intervention1: Two different augmentation dosages of folic acid were compared in female patients with depressive episodes taking fluoxetine: fluoxetine: 20mg/day, Folic acid: 1.5mg/day and 5mg/day Control Intervention1: Folic acid: High (5mg/day) and low (1.5mg/day) doses, oral route, six weeks CONDITION: Depressive episodes (moderate depressive episodes without somatic symptoms, moderate depressive episodes with somatic symptoms and severe depressive episodes without psychotic symptoms) PRIMARY OUTCOME: Scores on HDRS and Beck depression inventory (BDI)‐‐‐‐‐‐Timepoint: Days 0,7,14, 21, 28, 35 and 42 SECONDARY OUTCOME: NIL‐‐‐‐‐‐Timepoint: NIL 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