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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.
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.'
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risperidone | Experimental | Oral Risperidone 2-6 mg/day. Dose titrated based on clinical response and tolerability over 6 weeks. Administered once daily.' |
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| Cariprazine | Active Comparator | Oral Cariprazine 1.5-6 mg/day,dose will be titrated based on clinical response |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.' |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maera Hussain | Contact | +92-3160886631 | maerahussain802@gmail.com |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| C533287 | cariprazine |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Randomized parallel assignment, double-blind, active-controlled trial comparing Risperidone vs Cariprazine in adults with acute manic episodes over 6 weeks.'
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| 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 |
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