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Effect of Spirinolactone in treatment of Schizophrenia

Effect of Spirinolactone as an Adjuvant Therapy on Improvement of Negative Signe and Cognitive Symptoms in Schizophrenic Patients ; A randomized, double-blind clinical trial with placebo control

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090117001556N120
Enrollment
50
Registered
2019-10-12
Start date
2019-10-22
Completion date
Unknown
Last updated
2020-10-06

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: Tablet Risperidone (6 mg/day) combined with 100 mg/day Spironolactone as intervention group for 8 weeks. Intervention 2: Control group: Tablet Risperidone (6 mg/day

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Diagnosis of Schizophrenia based on DSM-5 criteria Age between 18-50 Chronic Schizophrenia- duration of the disorder more than 2 years Minimum score of 19 in negative sub score

Exclusion criteria

Exclusion criteria: Any serious medical or neurological problem IQ less than 70 Substance dependence during the last 6 months(except for nicotine and caffeine) Receiving ECT during the last 2 weeks Serum potassium more than 5 meq/L History of cardiosurgery Receiving oral antipsychotics during the last week or long-standing antipsychotic during the last month Meeting the criteria of major depressive disorder Suicidality Concurrent consumption of alcohol Pregnant or lactating women Receiving Pentoxifylline

Design outcomes

Primary

MeasureTime frame
Severity of schizophrenia. Timepoint: Baseline and weeks 2- 4- 8 after beginning of treatment. Method of measurement: by Positive and Negative Symptoms Scale.

Secondary

MeasureTime frame
Cognitive symptoms. Timepoint: Baseline and weeks 2- 4- 8 after beginning of treatment. Method of measurement: by MMSE.

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 4, 2026