Protocol summary

Summary
Improving neurocognitive physiopathological aspect of schizophrenia is a current challenge to identify the pathway to develop goal directed clinical interventions in practice. Aims and objectives: In the present study we will examin the effect of Raloxifine as a selective estrogen modulator and Isradipine as a voltage gated L type calcium channel blocker on improvement of schizophrenic patients cognitive deficits. We designed and performed double blind randomized clinical trials in Zanjan province. 60 patients with schizophrenia or schizoaffective diagnosis, without intellectual disability and systolic blood pressure higher than 100 mmHg and Diastolic pressure above 60 mmHg will recruit in 3 specific groups, will receive 2 times a day, Isradipine capsule 5 mg or Raloxifine tablet 60 mg or placebo in each group. The drugs were given to the patients in capsules with the same color and shape for 6 consequent weeks alongside treatment with conventional antipsychotics. Patients with comorbid chronic diseases in DSM-V axis I, history of life time abuse of substance and any other neurological disorders will be excluded. Initial and final lab data such as (INR, PT, FSH, LH, ALT, AST, ALK, TSH, T3, T4), ECG, positive and negative syndrome scale as well as cognitive tests in specific domains such as attention, processing speed, executive function, verbal memory will be investigated then comparison between groups will be checked.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010225812N1
Registration date: 2017-08-14, 1396/05/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-14, 1396/05/23
Registrant information
Name
Bita Vahdani
Name of organization / entity
Zanjan University of Medical Sciences, Shahid Beheshti Hospital
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4000
Email address
bt_vahdani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2016-05-01, 1395/02/12
Expected recruitment end date
2017-09-28, 1396/07/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of Raloxifine and Isradipine in cognitive impairment of schizophrenic patients
Public title
Comparison of Raloxifene and Isradipine Administration in Improvement of Schizophrenic Patients’ Cognitive Deficits.
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanjan
Postal code
4515613191
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
zums.rec.1394.332

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20,
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders

2

Description of health condition studied
Schizoaffective,
ICD-10 code
F25,
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders

Primary outcomes

1

Description
Attention
Timepoint
baseline and week 6
Method of measurement
The Stroop Color and Word test

2

Description
Executive Function
Timepoint
baseline and week 6
Method of measurement
The Wisconsin Card Sorting Test (WCST)

3

Description
Processing Speed
Timepoint
baseline and week 6
Method of measurement
Wechsler Digit Coding Task, Symbol III

4

Description
Memory
Timepoint
baseline and week 6
Method of measurement
Wechsler, Verbal Memory test

5

Description
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 outcomes

1

Description
PT, PTT, INR
Timepoint
baseline and week 6
Method of measurement
Blood sample

2

Description
LH, FSH, Vit D3
Timepoint
baseline and week 6
Method of measurement
blood sample

3

Description
Side effect self report form
Timepoint
Up to 6 weeks
Method of measurement
Patient report

4

Description
Change in ECG
Timepoint
Baseline and week 6
Method of measurement
ECG to confirm inclusion into study and compared at week 6 to baseline

5

Description
Change in chemistry panel ( TSH, T3, T4)
Timepoint
Baseline and week 6
Method of measurement
Blood sample

6

Description
AST, ALT, ALKP
Timepoint
baseline and week 6
Method of measurement
Blood sample

Intervention groups

1

Description
Tablet Raloxifine 60 mg, Two times a day, 6 weeks,
Category
Treatment - Drugs

2

Description
Capsule Isradipine 5 mg, 2 Times a day, 6 weeks
Category
Treatment - Drugs

3

Description
Capsule Placebo, 2 times a day, 6 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Psychiatry Hospital,
Full name of responsible person
Dr. Bita Vahdani
Street address
Are Square, Beheshti Hospital, Department of Pychiatry
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Zanjan University of Medical Sciences
Full name of responsible person
Dr. Shoghli, finance and administrative research affair
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanajn
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Bita Vahdani
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Zanjan University of Medical Sciences, Beheshti Hospital, Psychiatry Department
City
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
bt_vahdani@zums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanajn University of Medical Sciences
Full name of responsible person
Dr Alireza Armani kian
Position
Psychiatrist- Psychosomatic Fellowship
Other areas of specialty/work
Street address
Zanjan University of Medical Sciences, Beheshti Hospital
City
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2402
Email
dr.armani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Bita Vahdani
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Zanjan, Beheshti hospital, Department of Psychiatry
City
zanjan
Postal code
45136-15788
Phone
+98 24 3354 4001
Fax
+98 24335424032403
Email
bt_vahdani@zums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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