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

Evaluation the efficacy of Raloxifine and Isradipine in cognitive impairment of schizophrenic patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016010225812N1

Enrollment

Registered

2017-08-14

Start date

2016-05-01

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

Condition 1: Schizophrenia. Condition 2: Schizoaffective,. Schizophrenia, schizotypal and delusional disorders Schizophrenia, schizotypal and delusional disorders

Interventions

Intervention 1: Tablet Raloxifine 60 mg, Two times a day, 6 weeks,. Intervention 2: Capsule Isradipine 5 mg, 2 Times a day, 6 weeks. Intervention 3: Capsule Placebo, 2 times a day, 6 weeks.

Treatment - Drugs

Tablet Raloxifine 60 mg, Two times a day, 6 weeks,

Capsule Isradipine 5 mg, 2 Times a day, 6 weeks

Capsule Placebo, 2 times a day, 6 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Bita Vahdani

Zanjan University of Medical Sciences

bt_vahdani@zums.ac.ir+98 24 3354 4001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026