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A clinical trial to study the effects of Aripiprazole in Risperidone induced increased prolactin level and its consequences.

Aripiprazole supplementation in Risperidone induced hyperprolactinemia: A randomized, double blind placebo controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/11/003114
Enrollment
30
Registered
2012-11-16
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: null- Schizophrenia

Interventions

Intervention1: Aripiprazole: 10 mg Aripiprazole given orally at night for 8 weeks Control Intervention1: Placebo: Similar looking tablets with no effect or side effects

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Schizophrenia who were maintaing well on Tab Risperidone atleast 4 mg for the minimum duration of 12 weeks

Exclusion criteria

Exclusion criteria: Patient who is having serious medical illness Patient who is having seizure disorder Patient who requires dose modification Patients who were not able to give consent

Design outcomes

Primary

MeasureTime frame
Patients in Aripiprazole group will have atleast fifty percent reduction in hyperprolactinemia compared to placebo groupTimepoint: After 8 weeks serum prolactin level is measured—

Secondary

MeasureTime frame
Patients have symptomatic improvement in terms of prolactin related adverse effects like sexual dysfunction, amenorrhoea, galactorrhoea in Aripiprazole groupTimepoint: 8 weeks—

Countries

India

Contacts

Public ContactR Venkateswaran

PSGIMSR

raghuthaman_gopal@yahoo.co.in919789459987

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 15, 2026