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An Interventional Study to look at efficacy of Fluoxetine in patients with Post-stroke anxiety

TO STUDY EFFICACY OF FLUOXETINE IN POST-STROKE ANXIETY-A RANDOMIZED CONTROLLED TRIAL

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/12/016568
Enrollment
60
Registered
2018-12-10
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: F419- Anxiety disorder, unspecified Health Condition 2: G46- Vascular syndromes of brain in cerebrovascular diseases

Interventions

Intervention1: Fluoxetine: 20 mg OD x 12 weeks Control Intervention1: Standard Care: 0

Sponsors

Dr Satish Barki
Lead Sponsor
Indian Council of Medical Research
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. All stroke(ischemic and hemorrhagic) and transient ischemic attack patients of age more than or equal to 18 year within six months of ictus 2. Willing to participate in the study 3. Can understand Hindi or English

Exclusion criteria

Exclusion criteria: 1. Unwillingnes to participate in the study 2. Patients with aphasia or severe cognitive deficits 3. Known psychiatric diseases 4. Patients with moderate to severe depression (MAM-D > 13)

Design outcomes

Primary

MeasureTime frame
Improvement in HAM-A score after 12 weeks of treatmentTimepoint: Improvement in HAM-A score after 12 weeks of treatment

Secondary

MeasureTime frame
1. Frequency of anxiety and depression after stroke 2. Activities of daily living as measured on scale such as Barthel index 3. Improvement in QoL as measured by 36 item short form questionnaire(SF-36) after 12 weeks of treatmentTimepoint: 12 weeks

Countries

India

Contacts

Public ContactDr Deepti Vibha

All India Institute Of Medical Sciences, New Delhi

deeptivibha@gmail.com9968859848

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026