Risperidone vs Cariprazine in Acute Mania

ConditionBipolar 1 Disorder

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-60

SponsorPakistan Institute of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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.'
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

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: RisperidoneExperimental treatment 1 intervention

Group B: CariprazineActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline,week 6

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pakistan Institute of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

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