Risperidone vs Cariprazine in Acute Mania

NCT07665073 | Not Yet Recruiting Phase 4

• 1 other identifier: PIMS-PSY-RCT-2026-01
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized, double-blind, parallel-group study comparing efficacy and safety of Risperidone versus Cariprazine in adults with acute manic episodes. Participants will receive oral study drug for 6 weeks. Primary outcome is change in YMRS total score from baseline to week 6.

Conditions

Bipolar 1 Disorder

Outcome Measures

Primary Outcomes (1)

• Change in YMRS total score from baseline to week 6

  The Young Mania Rating Scale YMRS is an 11-item clinician-rated scale measuring mania severity. Total score ranges 0-60, with higher scores indicating greater mania severity. Primary endpoint is change from baseline to week 6.

  Baseline,week 6

Study Arms (2)

Risperidone

EXPERIMENTAL

Oral Risperidone 2-6 mg/day. Dose titrated based on clinical response and tolerability over 6 weeks. Administered once daily.'

Drug: Risperidone

Cariprazine

ACTIVE COMPARATOR

Oral Cariprazine 1.5-6 mg/day,dose will be titrated based on clinical response

Drug: Cariprazine

Interventions

Risperidone DRUG

Oral Risperidone tablets, 2-6 mg/day administered once daily for 6 weeks. Dose titrated based on clinical response and tolerability. Approved antipsychotic for acute mania.'

Risperidone

Cariprazine DRUG

Oral Cariprazine capsules, 1.5-6 mg/day administered once daily for 6 weeks. Dose titrated based on clinical response and tolerability. Approved antipsychotic for acute mania

Cariprazine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with bipolar mania Age 18-60 YMRS\>20 -

You may not qualify if:

• Patients with substance use Patients already taking antipsychotics Secondary mood disorder

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

MeSH Terms

Interventions

Risperidone; cariprazine

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Maera Hussain

CONTACT

+92-3160886631; maerahussain802@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident psychiatrist Pims

Model Details: Randomized parallel assignment, double-blind, active-controlled trial comparing Risperidone vs Cariprazine in adults with acute manic episodes over 6 weeks.'

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share