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Fingolimod in the treatment of schizophrenia

Fingolimod as an adjuvant therapy added to Risperidone in the treatment of schizophrenia : A randomized double blind and placebo controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090117001556N137
Enrollment
50
Registered
2021-08-01
Start date
2021-09-23
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

Schizophrenia. Schizophrenia

Interventions

Intervention 1: Intervention group: Risperidone 2 mg, three times/day + Fingolimod 0.5 mg everyday for 8 weeks. Intervention 2: Control group: Risperidone 2 mg, three times/day + Placebo tablet everyd

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Diagnosis of schizophrenia based on DSM-5 Minimum score of 60 based on PANSS Age range: 18-60 years old At least, 2 years have passed since the onset of the disorder

Exclusion criteria

Exclusion criteria: Diagnosis of another disorder in axis II Existence of a significant neurological or organic disease IQ less than 70 based on interviewer clinical suspicion Substance/drug dependence during the last 6 months (except nicotine and caffeine) Use of antipsychotics during past 1 week or long-term antipsychotics during past 1 month Receiving ECT during the last 2 weeks Abnormal endocrine activity Abnormal kidney and liver function History of thrombosis and emboli History of abnormal bleeding

Design outcomes

Primary

MeasureTime frame
Severity of schizophrenia. Timepoint: Baseline and weeks 4 and 8. Method of measurement: By Positive and Negative Syndrome Scale (PANSS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahin Akhondzadeh

Tehran University of Medical Sciences

s.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 12, 2026