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Comparison of Risperidone or Aripiprazole addition to Selective Serotonin Reuptake Inhibitors for treating Obsessive Compulsive Disorder

Comparative effectiveness of Risperidone versus Aripiprazole augmentation to Selective Serotonin Reuptake Inhibitors in Obsessive Compulsive Disorder - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069483
Enrollment
72
Registered
2024-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: F422- Mixed obsessional thoughts and acts

Interventions

Intervention1: Risperidone: Antipsychotic drug, Dose: 1-3 mg, Route: oral, Frequency: Daily, Period: 8 weeks. Control Intervention1: Aripiprazole: Antipsychotic drug, Dose: 2.5 mg-10 mg, Route: oral,

Sponsors

Government Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients fulfilling the criteria for OCD as per ICD-11 and on treatment with a dose within therapeutic range for one or more than one SSRIs for 12 weeks and current YBOCS =16

Exclusion criteria

Exclusion criteria: 1. Patients with evidence of dementia, organic brain disorders like epilepsy, tumours, neurological lesions, stroke 2. Patients on Tricyclic Antidepressants 3. Patients with Intellectual Disability 4. Patients with substance dependence except nicotine and caffeine 5. Patients with co-morbid major mental illness 6. Past history of augmentation with risperidone or aripiprazole 7. History of hypersensitivity/allergic reaction to risperidone and aripiprazole

Design outcomes

Primary

MeasureTime frame
Compare clinical response to both the drugs which would be measured by reduction in the Y-BOCS and CGI scoresTimepoint: 0, 2, 4, 6, 8 weeks

Secondary

MeasureTime frame
Compare effect on QoL (measured by WHOQOL-BREF Hindi), sexual functioning (measured by ASEX), cognitive functioning (measured by HMoCA, DSST, TMT, DST), depressive and anxiety symptoms (measured by HDRS-17, HAM-A), and, also to assess the safety profile of both the drugs (measured by GASS)Timepoint: 0, 2, 4, 6, 8 weeks

Countries

India

Contacts

Public ContactDr Shivangi Mehta

Government Medical College and Hospital

shivangi02@gmail.com9855784512

Outcome results

None listed

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