clozapine-resistant schizophrenia. Schizophrenia
Conditions
Interventions
Intervention 1: Intervention group: In the intervention group, in addition to treatment with clozapine, patients are treated with ursodeoxycholic acid (C24H40O4) capsules, 300 mg twice daily (Ursodiol
Sponsors
Zahedan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Patients aged 18 to 60 admitted to psychiatric care centers in Zahedan with acute symptoms of schizophrenia, whose diagnosis of clozapine-resistant schizophrenia has been confirmed by an experienced psychiatrist based on the Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV)." These patients must have been treated with clozapine for at least 6 months, with serum clozapine levels consistently maintained above 350 ng/ml during at least 12 weeks of weekly monitoring. This dosage level, based on the Schulte study, is considered the minimum necessary for clozapine treatment before diagnosing clozapine-resistant schizophrenia (CRS), except in cases where patients were unable to tolerate reaching this 'threshold level.' "Despite effective treatment with an adequate dosage and for a sufficient duration in these patients, the 'remission criteria' proposed by Andreasen et al., defined as achieving a score of =3 on 8 specific PANSS items — including P1: 'Delusions'; P2: 'Conceptual Disorganization'; P3: 'Hallucinatory Behavior'; N1: 'Blunted Affect'; N4: 'Passive/Apathetic Social Withdrawal'; N6: 'Lack of Spontaneity and Flow of Conversation'; G5: 'Mannerisms and Posturing'; and G9: 'Unusual Thought Content' — have not been met for the patient." "Additionally, 18- to 60-year-old patients admitted to psychiatric care centers in Zahedan with chronic clozapine-resistant schizophrenia, without acute symptoms of schizophrenia, and who are capable of verbal communication are eligible to participate in the study."
Exclusion criteria
Exclusion criteria: Pregnancy Breast feeding Women without adequate contraception Concurrent use of glutamate modulators Uncontrolled epilepsy Myocardial infarction History of hypersensitivity to Ursodeoxycholic Acid History of recent head trauma or previous neurosurgeries Serious medical or neurological disorders Electroconvulsive therapy during the last two weeks prior to the start of the study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the effectiveness of adjunctive ursodeoxycholic acid in patients with clozapine-resistant schizophrenia in terms of the cognitive performance. Timepoint: 1, 2, 3, and 6 months after the initiation of treatment in the intervention and control groups. Method of measurement: The demographic information and “baseline characteristics” form and the Mini-Mental State Examination (MMSE). | — |
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the effectiveness of adjunctive ursodeoxycholic acid in patients with clozapine-resistant schizophrenia in terms of the severity of psychotic symptoms. Timepoint: 1, 2, 3, and 6 months after the initiation of treatment in the intervention and control groups. Method of measurement: The demographic information and “baseline characteristics” form and the Positive and Negative Syndrome Scale for Schizophrenia (PANSS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Khazaei Moghaddam
Zahedan University of Medical Sciences
Outcome results
None listed