Protocol summary

Summary
The aim of the study: To determine the effect of adding omega3 on metabolic and inflammatory mediators in patients with schizophrenia treated with clozapine and valproate in Hejazi and Ibn e Sina hospital in Mashhad. Study design: Randomized, double-blind, placebo-controlled, single-center, phase II trial. Inclusion criteria: patients with schizophrenia admitted in Hejazi and Ibn Sina hospital in Mashhad that treated with clozapine and valproate at least 3 months (clozapine dose of 200 to 400 mg); Age 18 years or older; triglyceride levels in the morning between 200 to 499 Milligrams per deciliter; metabolic indices of patients before starting treatment with clozapine and valproate are normal. Exclusion criteria: Pregnancy or Lactation; history of sensitivity to fish oil; use of omega3 in the past few months; Having obvious bleeding disorders or a history of using heparin and coumarin; The reluctance of patients participating in the study; use of other drugs such as statins; history of consumption or abuse of alcohol or drugs within 6 months from baseline. Intervention: In the intervention group all patients who received clozapine daily 300 to 400 mg a day for 3 months receive omega3 (4 Grams per day) for 8 weeks. In the control group patients who received clozapine 300 to 400 mg a day for 3 months received placebo for 8 weeks. The primary outcome or consequences of the study: inflammatory mediators and metabolic changes. The primary outcome: Height, weight, waist circumference, body mass index, triglyceride levels, total cholesterol, LDL, HDL and CRP and inflammatory markers HSP, PAB, SOD, ZN, CU at the beginning and end of week 8.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201603095280N23
Registration date: 2016-05-06, 1395/02/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-06, 1395/02/17
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2014-09-21, 1393/06/30
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment efficacy of omega-3 on metabolic and inflammatory Indices in patients with schizophrenia taking clozapine and sodium valproate in Mashhad, Iran
Public title
Effect of omega-3 on metabolic and inflammatory indices in patients with chronic schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with schizophrenia admitted in Hejazi and Ibn Sina hospital in Mashhad that treated with clozapine and valproate at least 3 months (clozapine dose of 200 to 400 mg); Age 18 years or older; triglyceride levels in the morning between 200 to 499 Milligrams per deciliter; metabolic indices of patients before starting treatment with clozapine and valproate are normal. Exclusion criteria: Pregnancy or Lactation; history of sensitivity to fish oil; use of omega-3 in the past few months; Having obvious bleeding disorders or a history of using heparin and coumarin; The reluctance of patients participating in the study; use of other drugs such as statins; history of consumption or abuse of alcohol or drugs within 6 months from baseline.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 56
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
Ethics Committee of Mashhad University of Medical sciences
Street address
Qoreishi Building, Daneshgah St.
City
Mashhad
Postal code
Approval date
2014-01-15, 1392/10/25
Ethics committee reference number
921429

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
height
Timepoint
baseline and week 8
Method of measurement
meter

2

Description
Weight
Timepoint
baseline and week 8
Method of measurement
scale

3

Description
abdominal circumference
Timepoint
baseline and week 8
Method of measurement
meter

4

Description
BMI
Timepoint
baseline and week 8
Method of measurement
kg/m2

5

Description
Triglyceride levels
Timepoint
baseline and week 8
Method of measurement
blood test

6

Description
Cholesterol
Timepoint
baseline and week 8
Method of measurement
blood test

7

Description
LDL
Timepoint
baseline and week 8
Method of measurement
blood test

8

Description
HDL
Timepoint
baseline and week 8
Method of measurement
blood test

9

Description
CRP
Timepoint
baseline and week 8
Method of measurement
blood test

10

Description
Inflammatory Mediators
Timepoint
baseline and week 8
Method of measurement
blood test

11

Description
CBC
Timepoint
baseline and week 8
Method of measurement
blood test

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group all patients who received clozapine daily 300 to 400 mg a day for 3 months receive omega-3 (4 gr/day) for 8 weeks
Category
Treatment - Drugs

2

Description
In the control group patients who received clozapine 300 to 400 mg a day for 3 months received placebo for 8 weeks .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn E Sina Hospital
Full name of responsible person
Dr Narjes Roudbaraki
Street address
Ibn-e-Sina Hospita, Bu-Ali Sq., Amel Blvd., Mashhad, Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mahyar Mirheydari
Street address
Qoreishi Building, Daneshgah St.
City
Mashhad
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, Mashhad 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
Ibn e Sina Hospital
Full name of responsible person
Dr Narjes Roudbaraki
Position
Resident
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital, Bu-Ali Sq., Amel Blvd., Mashhad,Iran.
City
Mashhad
Postal code
Phone
+98 51 3711 2701
Fax
Email
roudbarakin911@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Fatemeh Behdani
Position
associate professor
Other areas of specialty/work
Street address
Qoreishi Building, Daneshgah St.
City
Mashhad
Postal code
91388-13944
Phone
+98 51 3841 2081
Fax
Email
ramresearch@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Narjes Roudbaraki
Position
Resident
Other areas of specialty/work
Street address
Qoreishi Building, Daneshgah St.
City
Mashhad
Postal code
Phone
00
Fax
Email
roudbarakin911@mums.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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