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Assessment of Adverse Drug Reactions of Antidepressants in Psychiatric patients

Assessment of Adverse Drug Reactions of Antidepressants in Psychiatry Outpatient department of a Tertiary care Hospital- A Prospective Observational Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/084260
Enrollment
390
Registered
2025-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: F331- Major depressive disorder, recurrent, moderate

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Dr N Bhavana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient willing to provide informed consent 2. Outpatients who are Newly diagnosed as depressive disorder and are on Antidepressants attending Psychiatry OPD 3. Age greater than 18years and both sexes

Exclusion criteria

Exclusion criteria: 1. Patients who are critically ill and suffering from Malignancies 2. Those who were judged clinically to be at a suicidal risk 3. Known cases of allergy to medications 4. Those who had a history of substance abuse 5. Patients who are previously diagnosed as chronic alcoholic

Design outcomes

Primary

MeasureTime frame
TO assess the incidence, type and nature of adverse drug reaction associated with the use of Antidepressants in patients attending the Psychiatry OPDTimepoint: 3 months

Secondary

MeasureTime frame
To assess sexual dysfunction in patients using antidepressants using the Arizona Sexual Experience Scale (ASEX). To assess the causality of reported ADRs using the WHO-UMC Causality Assessment Scale. To evaluate the pattern of antidepressant use (monotherapy vs combination therapy) and their association with ADRs. To observe laboratory changes (CBC, LFT, RFT, Lipid Profile, ECG) over time in relation to ADRs. To identify risk factors contributing to ADRs (e.g., demographic factors, comorbidities, polypharmacy).Timepoint: 3 months

Countries

India

Contacts

Public ContactDr Nagesh H N

Shri Atal Bihari Vajpayee Medical College and Research Institute

nagu728@gmail.com09972279046

Outcome results

None listed

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