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Comparison of Raloxifene and Isradipine Administration in Improvement of Schizophrenic Patients’ Cognitive Deficits.

Phase 2
Conditions
Condition 1: Schizophrenia. Condition 2: Schizoaffective,.
Schizophrenia, schizotypal and delusional disorders
Registration Number
IRCT2016010225812N1
Lead Sponsor
Vice Chancellor for Research of Zanjan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Inclusion Criteria: All enrolled patients will have normal IQ ; systolic blood pressure more than 100 mmHg ; diastolic blood pressure more than 60 mmHg ; at least 2 years diagnosis of schizophrenia or schizoaffective disorder according to DSM-V diagnostic criteria.

Exclusion Criteria

patients with any other comorbidity of psychiatric or neurologic disorders ; history of lifetime substance abuse ; any sensitivity to drugs ; history of head trauma or loss of consciousness ; resistant high blood pressure ; resistance in treatment of schizophrenia or beginning Clozapine ; renal, liver or cardiac failure ; women' s pregnancy or breast feeding ; any abnormality in ECG ; suicide idea ; history of dementia ; breast cancer ; tromboemboli events ; dementia ; endocrine disease ; history of receiving ECT during last 12 months.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Attention. Timepoint: baseline and week 6. Method of measurement: The Stroop Color and Word test.;Executive Function. Timepoint: baseline and week 6. Method of measurement: The Wisconsin Card Sorting Test (WCST).;Processing Speed. Timepoint: baseline and week 6. Method of measurement: Wechsler Digit Coding Task, Symbol III.;Memory. Timepoint: baseline and week 6. Method of measurement: Wechsler, Verbal Memory test.;Structured Clinical Interview for the DSM-V (SCID). Timepoint: baseline and week 6. Method of measurement: Psychiatry resident will interview to confirm diagnosis for inclusion into study.
Secondary Outcome Measures
NameTimeMethod
PT, PTT, INR. Timepoint: baseline and week 6. Method of measurement: Blood sample.;LH, FSH, Vit D3. Timepoint: baseline and week 6. Method of measurement: blood sample.;Side effect self report form. Timepoint: Up to 6 weeks. Method of measurement: Patient report.;Change in ECG. Timepoint: Baseline and week 6. Method of measurement: ECG to confirm inclusion into study and compared at week 6 to baseline.;Change in chemistry panel ( TSH, T3, T4). Timepoint: Baseline and week 6. Method of measurement: Blood sample.;AST, ALT, ALKP. Timepoint: baseline and week 6. Method of measurement: Blood sample.
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