omega 3 and metabolic syndrome

Phase 2

• Conditions: schizophrenia, bipolar mood disorder, schizoaffective.; Schizophrenia ,Schizoaffective disorders ,Bipolar affective disorder; F20, F25,

• Registration Number: IRCT138712231764N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

psychiatric patients taking olanzapine plus sodium valproate or olanzapine plus lithium with clinical diagnosis of schizophrenia, bipolar mood disorder, schizoaffective disorder, ages between 18-60 yrs.

Exclusion criteria:
1- Previous treatment with study drugs (olanzapine, sodium valproate, lithium) during the three months prior to trial initiation/participation,
2- Having a significant active medical problem or abnormal lab tests before initiation of trial including:
Liver function tests= 3 normal ,
Thyroid stimulating hormone > 4.2 m.I.U/L,
GFR< 60 ml/min,
FBS> 125 mg/dl,
TG = 500 mg/dl ,
TG between 200-500 and Non-HDL cholesterol greater than or equal to 30+ target LDL: in cases of TG between 200-500, first Non-HDL cholesterol is calculated. Then the goal LDL of the patient is assessed according to NCEP ATP III LDL goals. Participants with TG between 200-500 are excluded if their Non-HDL cholesterol is greater than or equal to 30 + target LDL.
3- Pregnancy and lactation
4-Recent (within 4 weeks) consumption of omega 3 fatty acids
5-BMI = 30
6-Contraindications for the study drugs
7-Patients or their family refusal to participation
8-Taking Drugs much affecting study parameters.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified