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A study to see the outcome of adding Lumateperone if it helps win improving interaction and thinking skills in people with Schizophrenia.

Lumateperone as an adjunctive therapy in negative and cognitive symptoms of Schizophrenia: An open label study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/107153
Enrollment
60
Registered
2026-03-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: F200- Paranoid schizophrenia

Interventions

Intervention1: To assess the effect of Lumateperone as an adjunctive treatment for 6 weeks for negative symptoms and cognitive deficit in schizophrenia.: 30 patients receiving Cap. Lumateperone (42mg

Sponsors

Central Institute Of Psychiatry, Ranchi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. participants satisfying the ICD-11 criteria for schizophrenia 2.illness duration of equal to or more than 2 years 3. patient giving written informed consent 4. score less than or equal to 25 in Hindi Montreal cognitive assessment test 5. PANSS negative symptoms score of equal to or more than 4 or more than 15 combined. 6. SANS score more than 20

Exclusion criteria

Exclusion criteria: 1. Any other major comorbid psychiatric diagnosis or significant concurrent medical illness. 2. Patients with organic brain disorder and/or mental retardation. 3. Patients on treatment with medications that can influence cognitive functioning: Anticholinergics (except trihexyphenidyl). 4. Patients who have received ECT in the past 6 months. 5. Contraindications to use of Lumateperone.

Design outcomes

Primary

MeasureTime frame
Change in the severity of negative symptoms from baseline to 4 week SANS (Scale for Assessment of Negative Symptoms) total score and PANSS (Positive and Negative Syndrome Scale) negative subscale score. Timepoint: Baseline and 4 weeks.

Secondary

MeasureTime frame
Change in cognitive performance scores from baseline to 4 weeks. BACS (Brief Assessment of Cognition in Schizophrenia) composite score and MoCA (Montreal Cognitive Assessment) total score. Timepoint: Baseline and 4 weeks.

Countries

India

Contacts

Public ContactDr Anjanik K Rajan

Central Institute of Psychiatry

dralokpratap@gmail.com7781803812

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026