Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic features
Conditions
Interventions
Intervention1: Pharmacogenetic testing guided prescription of SSRI: SSRI drug for 8 weeks chosen on the basis of results of pharmacogenetic testing in patients prior to initiation of therapy
Control I
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: â�¢Newly diagnosed treatment na�¯ve patients of MDD according to The Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria. â�¢Moderate to severe cases according to HRDS-17 score â�¥ 17. â�¢Patient accompanied by reliable informant. â�¢Willing to give informed consent. â�¢Willing to come for scheduled follow-up.
Exclusion criteria
Exclusion criteria: 1. Patient having active suicidal ideations or behavior, or requiring hoospitalization. 2. Severe depression with psychotic features or seasonal affective disorder. 3. Depressive episode associated with protracted drug withdrawal, personality disorder, post-partum period or endocrinal disorder. 4. On psychotropic drugs for other illnesses especially any serotonergic drugs. 5. Patients having any other psychiatric illness including substance dependence (eg: nicotine). 6. Mental retardation that would interfere with evaluation of symptoms and assessment. 7. Severe organic or neurological pathology. 8. Having other significant comorbidities like uncontrolled diabetes, uncontrolled hypertension, BPH, erectile dysfunction etc. 9. Taking concomitant drugs which are major inhibitors / inducers of CYP2D6 and CYP2C9, or MAO inhibitors 10. Pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Mean change in total score of the 17-item Hamilton Depression Rating Scale (HDRS 17) from baseline to end of treatment in the two treatment groups. 2. Mean difference in total score of the Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) in the two treatment groups.Timepoint: 4 weeks and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of responders in the two treatment groups. (Response rate; response is defined as a reduction in HDRS total score of at least 50% at the end of treatment from baseline.) 2. Remission rates in the two treatment groups. (Remission is defined as an absolute HDRS total score of ââ?°Â¤7 at the end of treatment.)Timepoint: 4 weeks and 8 weeks | — |
Countries
India
Contacts
Public ContactDr Shubham Atal
All India Institute of Medical Sciences Bhopal
Outcome results
None listed