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Pregnenolone in the treatment of women with chronic schizophrenia

Pregnenolone in the treatment of women with chronic schizophrenia: a double blind randomized trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT201504211556N76
Enrollment
50
Registered
2015-04-22
Start date
2015-05-22
Completion date
Unknown
Last updated
2018-02-22

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: Tablet Risperidone (6 mg/day) combined with 50 mg/day Pregnenolone as intervention group for 8 weeks. Intervention 2: Tablet Risperidone (6 mg/day) combined with placebo as control gro
Treatment - Drugs
Placebo
Tablet Risperidone (6 mg/day) combined with 50 mg/day Pregnenolone as intervention group for 8 weeks

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:1-women with Diagnosis of Schizophrenia based on DSM- 5 criteria; 2- Minimum Score of 60 on Positive and Negative Scale; 3- Age between 18-45; 4-Chronic Schizophrenia- duration of the disorder more than 2 years; 5-Minimum score of 20 in negative sub score. Exclusion criteria: 1-Any serious medical or neurological problem; 2- IQ less than 70; 3- Substance dependence during the last 6 months(except for nicotine and caffeine); 4-receiving oral antipsychotic medications during the last week or receiving any depot antipsychotic medication during the last month; 5-receiving ECT during the last 14 days ; 6-Hepatic and renal diseases; 7- History of thromboembolism ; 8- History of abnormal uterine bleeding, uterine or breast canser; 9-CVA; 10-Hormone replacement therapy; 11- Endocrine abnormality.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of schizophrenia. Timepoint: Baseline and weeks 2-4-8 after beginig of treatment. Method of measurement: Positive and Negative Syndrome Scale (PANSS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Shahin 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 4, 2026