Cariprazine as an adjunct therapy for treatment of negative symptoms in patients with Schizophrenia

Cariprazine as an adjunct therapy for treatment of negative symptoms in patients with Schizophrenia – A randomized double blind placebo controlled trial

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070875

Enrollment

Registered

2024-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: F20- Schizophrenia

Interventions

Intervention1: Adjunctive Cariprazine Therapy: Capsule Cariprazine as adjunct to ongoing treatment in patients with Schizophrenia for period of 8 weeks orally at doses up to 6 mg (1.5mg x 3 days,3mg

Eligibility

Inclusion criteria

Inclusion criteria: 1) Schizophrenia diagnosed patients according to International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, ICD-10 Diagnostic criteria. 2) 20–55 years of age. 3) Disease course >2years. 4) PANSS negative symptoms score =4 in at least four items or =15 combined. 5) PANSS positive symptoms score =4 in at least three items or =10 combined. 6) CDSS score 7) Patients receiving treatment for schizophrenia with preferably second generation anti¬-psychotic 8)Those who give informed consent for participating in the study.

Exclusion criteria

Exclusion criteria: 1.Any other major co-morbid psychiatric diagnosis and substance dependence excluding nicotine & caffeine. 2.Significant medical or neurological illness including severe cardiovascular, hepatic, renal, [serum creatinine > 1.5 mg/dl], anaemia [Haemoglobin 3.History of substantial brain damage or any neurological disorders. 4.Pregnancy 5.Patients receiving treatment with any first-generation anti-psychotic / depot or long-acting anti-psychotic / anti-depressant.

Design outcomes

Primary

Measure	Time frame
Effectiveness of Cap.Cariprazine as adjunct therapy in negative symptoms in patients with schizophrenia as recorded on The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Negative symptom subscale (NSS) & Factor score for Negative Symptoms (FSNS) and The Scale for the Assessment of Negative Symptoms (SANS) along with the change in serum NCAM levels as measured by ELISA. Timepoint: Baseline and 8 weeks	—

Measure

Time frame

Effectiveness of Cap.Cariprazine as adjunct therapy in negative symptoms in patients with schizophrenia as recorded on The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Negative symptom subscale (NSS) & Factor score for Negative Symptoms (FSNS) and The Scale for the Assessment of Negative Symptoms (SANS) along with the change in serum NCAM levels as measured by ELISA. Timepoint: Baseline and 8 weeks

—

Secondary

Measure	Time frame
Improvement in Cognition after Cap.Cariprazine adjunct therapy as recorded by Montreal Cognitive assessment (MoCA) test and The Digit Symbol Substitution Test (DSST).Timepoint: Baseline and 8 weeks	—

Countries

India

Contacts

Public ContactSurendra Paliwal

Central Institute of Psychiatry

itsme.paliwal@gmail.com8005940887

Outcome results

None listed

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