Comparison of efficacy and tolerability of three different drugs in patients of schizophrenia

Comparative evaluation of efficacy, tolerability and effect on quality of life of Cariprazine, Risperidone and Olanzapine in patients of Schizophrenia: A prospective randomized open label trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071231

Enrollment

Registered

2024-07-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F209- Schizophrenia, unspecified

Interventions

Intervention1: CARIPRAZINE: Cariprazine is a potential antipsychotic which got Drug Controller General of India (DCGI) approval in 2021. It is a dopamine D2 – and D3 -receptor partial agonist, with hi

(Visits at 0,3,6,12 weeks) All doses are titrated at three weeks by the treating psychiatrist. So, during the first visit patients will be prescribed medicines for a period of three weeks Frequency- O

(Visits at 0,3,6,12 weeks) All doses are titrated at three weeks by the treating psychiatrist. So, during the first visit patients will be prescribed medicines for a period of three weeks. Frequency-

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: - Newly diagnosed patients of schizophrenia as diagnosed by psychiatrist according to DSM 5 criteria. - PANSS score between 80-120 at baseline - Patients/Legally Acceptable Representative (LAR) willing to give written informed consent - Either gender aged between 18-70 years

Exclusion criteria

Exclusion criteria: 1) Patients on medications known to interact significantly with any of the study drugs 2) Dementia related Psychosis 3) Seizure Disorder 4) Patients with history suggestive of: a) Severe Liver/Kidney Damage b) Substance dependence 5) Pregnant and lactating women 6) Patients on multidrug therapy for schizophrenia (more than one drug from the above mentioned)

Design outcomes

Primary

Measure	Time frame
To evaluate and compare the efficacy of Cariprazine, Risperidone & Olanzapine in patients of schizophrenia by comparing mean change in PANSS & BPRS score.Timepoint: 0,3,6,12 weeks	—

Secondary

Measure	Time frame
ADHERENCE To assess and compare adherence to therapy with Cariprazine, Risperidone & Olanzapine in patients of Schizophrenia using MARS adherence scaleTimepoint: 03,06,12 WEEKS;QUALITY OF LIFE To compare effect of Cariprazine, Risperidone & Olanzapine on quality of life in patients of Schizophrenia using abbreviated version of Heinrich carpenter quality of life scale.Timepoint: 0,3,6,12 WEEKS;TOLERABILITY To compare effect of Cariprazine, Risperidone & Olanzapine on quality of life in patients of Schizophrenia using abbreviated version of Heinrich carpenter quality of life scaleTimepoint: 03.06,12 weeks	—

Measure

Time frame

ADHERENCE To assess and compare adherence to therapy with Cariprazine, Risperidone & Olanzapine in patients of Schizophrenia using MARS adherence scaleTimepoint: 03,06,12 WEEKS;QUALITY OF LIFE To compare effect of Cariprazine, Risperidone & Olanzapine on quality of life in patients of Schizophrenia using abbreviated version of Heinrich carpenter quality of life scale.Timepoint: 0,3,6,12 WEEKS;TOLERABILITY To compare effect of Cariprazine, Risperidone & Olanzapine on quality of life in patients of Schizophrenia using abbreviated version of Heinrich carpenter quality of life scaleTimepoint: 03.06,12 weeks

—

Countries

India

Contacts

Public ContactDr Smita Sontakke

Shri Vasantrao Naik Govt. Medical College, Yavatmal

smitaavanti@yahoo.co.in9923597661

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026