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

A randomized double-blind comparison of fluoxetine augmentation by high and low dosage folic acid in patients with depressive episodes

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001249

Enrollment

Registered

2010-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 Con

Eligibility

Inclusion 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

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactC Naveen Kumar

Deemed University under the Ministry of Health and Family Welfare, Govt of India

cnkumar1974@gmail.com08026995254

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026