Bipolar 1 DisorderPhase 4RCAMNCT07665073
Risperidone vs Cariprazine in Acute Mania
A Phase 4 study testing Risperidone and Cariprazine in people with Bipolar 1 Disorder, run by Pakistan Institute of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar 1 Disorder
- What is being tested?
- Risperidone and Cariprazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2027to Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with bipolar mania Age 18-60 YMRS>20 -
Who cannot join
- Patients with substance use Patients already taking antipsychotics Secondary mood disorder
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.'
- Conditions
- Bipolar 1 Disorder
- Being tested
- Risperidone, Cariprazine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
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.'
CariprazineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Risperidone | Experimental | Oral Risperidone 2-6 mg/day. Dose titrated based on clinical response and tolerability over 6 weeks. Administered once daily.' Receives: Drug: Risperidone |
| Cariprazine | Active comparator | Oral Cariprazine 1.5-6 mg/day,dose will be titrated based on clinical response Receives: Drug: Cariprazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline,week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startJun 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar 1 DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel assignment, double-blind, active-controlled trial comparing Risperidone vs Cariprazine in adults with acute manic episodes over 6 weeks.'
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maera Hussain, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665073
- Sponsor's protocol ID
- PIMS-PSY-RCT-2026-01
- Acronym
- RCAM
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risperidone vs Cariprazine in Acute Mania a Head to Head Comparison of Efficacy vs Tolerability
- ClinicalTrials.gov ID
- NCT07665073
- Acronym / sponsor ID
- RCAM / PIMS-PSY-RCT-2026-01
- Conditions
- Bipolar 1 Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- Jun 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.'
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized parallel assignment, double-blind, active-controlled trial comparing Risperidone vs Cariprazine in adults with acute manic episodes over 6 weeks.'
| Arm | Type | Receives |
|---|---|---|
| Risperidone | Experimental | Drug: RisperidoneOral Risperidone 2-6 mg/day. Dose titrated based on clinical response and tolerability over 6 weeks. Administered once daily.' |
| Cariprazine | Active comparator | Drug: CariprazineOral Cariprazine 1.5-6 mg/day,dose will be titrated based on clinical response |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with bipolar mania Age 18-60 YMRS>20 -
Key exclusion criteria (2 listed)
- Patients with substance use Patients already taking antipsychotics Secondary mood disorder
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisperidoneOral 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 | Risperidone |
| CariprazineOral 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 | Drug | Cariprazine |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risperidone and Cariprazine in people with Bipolar 1 Disorder, run by Pakistan Institute of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maera Hussain (+92-3160886631, maerahussain802@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in YMRS total score from baseline to week 6 (time frame: Baseline,week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.