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Testing if Ursodeoxycholic acid Helps People with Schizophrenia When Added to Usual Medicines

Ursodeoxycholic acid as an adjunctive therapy in patients with Schizophrenia : an MRS-based open-label study - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/095659
Enrollment
40
Registered
2025-10-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: F20-F29- Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders

Interventions

Intervention1: Tab. Ursodeoxycholic acid 300mg: Tab. Ursodeoxycholic acid 300mg twice daily for 6 weeks + treatment as usual. Control Intervention1: Treatment as Usual: Treatment as Usual

Sponsors

Central Institute of Psychiatry, Ranchi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female inpatients satisfying ICD 11 criteria of Schizophrenia. 2. Illness duration of minimum 2 years 3. Patients who are drug free for 4 weeks of oral and 8 weeks of depot antipsychotic medications / drug naive 4. Those who give informed consent for participating in the study.

Exclusion criteria

Exclusion criteria: 1. Any other major comorbid psychiatric diagnosis and substance dependence excluding nicotine and caffeine. 2. Current or past history of severe/significant medical or neurological illness. 3. Known hypersensitivity to Tab Ursodeoxycholic acid (Urticaria, Pruritus, Erythematous rash, Angioedema, Bronchospasm, Hypotension, Anaphylaxis) 4. Contraindications to use of Ursodeoxycholic acid (Complete Billiary Obstruction, Acute Cholecystitis or Chloangitis, Calcified Gallstones, Pregnancy, Lactation, Severe Liver Disease or Decompensated Cirrhosis) 5. A patient who had received ECT in the last 6 months.

Design outcomes

Primary

MeasureTime frame
Changes in Glutamate levels in DLPFC detected by MRSTimepoint: 0 and 6 weeks

Secondary

MeasureTime frame
Changes in score of PANSS, BPRS, CDSS, MOCA and CGI scalesTimepoint: 0, 4 weeks and 6 weeks.

Countries

India

Contacts

Public ContactDr Santosh Kumar Sinha

Central Institute of Psychiatry, Ranchi

dranjanikkumarcip@gmail.com7766817961

Outcome results

None listed

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