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Effect of omega-3 on metabolic and inflammatory indices in patients with chronic schizophrenia

Assessment efficacy of omega-3 on metabolic and inflammatory Indices in patients with schizophrenia taking clozapine and sodium valproate in Mashhad, Iran

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201603095280N23
Enrollment
56
Registered
2016-05-06
Start date
2014-09-21
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

Schizophrenia. Schizophrenia

Interventions

Intervention 1: 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. Intervention 2: In the control group patien
Treatment - Drugs
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
In the control group patients who received clozapine 300 to 400 mg a day for 3 months received placebo for 8 weeks .

Sponsors

Vice chancellor for research, Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Height. Timepoint: baseline and week 8. Method of measurement: meter.;Weight. Timepoint: baseline and week 8. Method of measurement: scale.;Abdominal circumference. Timepoint: baseline and week 8. Method of measurement: meter.;BMI. Timepoint: baseline and week 8. Method of measurement: kg/m2.;Triglyceride levels. Timepoint: baseline and week 8. Method of measurement: blood test.;Cholesterol. Timepoint: baseline and week 8. Method of measurement: blood test.;LDL. Timepoint: baseline and week 8. Method of measurement: blood test.;HDL. Timepoint: baseline and week 8. Method of measurement: blood test.;CRP. Timepoint: baseline and week 8. Method of measurement: blood test.;Inflammatory Mediators. Timepoint: baseline and week 8. Method of measurement: blood test.;CBC. Timepoint: baseline and week 8. Method of measurement: blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Narjes Roudbaraki

Ibn e Sina Hospital

roudbarakin911@mums.ac.ir+98 51 3711 2701

Outcome results

None listed

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