Risperidone vs Cariprazine in Acute Mania
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Risperidone, Cariprazine.
- Who it may be relevant to
- Registry conditions: Bipolar 1 Disorder. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Risperidone vs Cariprazine in Acute Mania a Head to Head Comparison of Efficacy vs Tolerability
Overview
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.
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.'
Interventions
- 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.' - 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
Primary outcome measures
- Change in YMRS total score from baseline to week 6 [Time frame: Baseline,week 6]
Eligibility criteria
Inclusion criteria
patients with bipolar mania Age 18-60 YMRS>20 -
Exclusion criteria
Patients with substance use Patients already taking antipsychotics Secondary mood disorder
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07665073 · PIMS-PSY-RCT-2026-01