Risperidone vs Cariprazine in Acute Mania (RCAM)

June 18, 2026 updated by: Maera Hussain, Pakistan Institute of Medical Sciences

Risperidone vs Cariprazine in Acute Mania a Head to Head Comparison of Efficacy vs Tolerability

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, active-controlled, parallel assignment clinical trial conducted at Pakistan Institute of Medical Sciences, Islamabad. Adults aged 18-65 with ICD 11 diagnosis of Bipolar I Disorder, current episode manic, will be randomized 1:1 to receive Risperidone or Cariprazine for 6 weeks. The study aims to compare reduction in mania symptom severity and tolerability between the two antipsychotics. Assessments include YMRS, UKU and safety parameters at baseline, week 3, and week 6.'

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

Patients with substance use Patients already taking antipsychotics Secondary mood disorder

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Risperidone
Oral Risperidone 2-6 mg/day. Dose titrated based on clinical response and tolerability over 6 weeks. Administered once daily.'
Drug: Risperidone
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.'
Active Comparator: Cariprazine
Oral Cariprazine 1.5-6 mg/day,dose will be titrated based on clinical response
Drug: Cariprazine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in YMRS total score from baseline to week 6
Time Frame: Baseline,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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2027

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIMS-PSY-RCT-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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