Omega-3 Fatty Acids Efficacy in First-episode of Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

There is accumulating experimental evidence to suggest the role of essential fatty acids (EFA) in neuronal migration, pruning and synaptic plasticity. These processes are implied to be dysfunctional on early stages of schizophrenia, according to neurodevelopmental hypothesis. Numerous epidemiological and clinical trial data support the benefit of EFA rich diets in reducing symptoms in schizophrenia. An EFA rich diet might be of particular importance at the beginning of the illness. As a relatively safe option, EFA supplementation would be a preferable add on therapy in treating individuals with a first episode of schizophrenia (FES) and a short duration of psychotic symptoms. No long term follow-up studies of EFA supplementation in FES patients were carried out. The demonstration of the efficacy of the prophylactic properties of EFAs in relapse prevention in FES patients would be a strong basis for further studies and prescribing EFAs for a large population of patients who are in the early stages of that debilitating illness.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Omega-3 Fatty Acid Deficiency Replacement in Early Schizophrenia

NCT00585390

Schizophrenia Fatty Acid Deficiency

COMPLETED PHASE2/PHASE3

Omega-3 Dietary Supplements in Schizophrenia

NCT01786239

Schizophrenia Schizophreniform Disorder Schizoaffective Disorder +2 more

COMPLETED NA

Indicated Prevention With Omega-3 Fatty Acids in Adolescents With 'At-Risk-Mental-State' for Psychosis

NCT00396643

Schizophrenia Prodrome

COMPLETED PHASE4

Treatment of Schizophrenia With an Omega-3 Fatty Acid (EPA) and Antioxidants

NCT00419146

Schizophrenia Schizophreniform Disorders Schizoaffective Disorder +1 more

COMPLETED PHASE2/PHASE3

The Influence of Omega-3 Fatty Acid on the Violence of Schizophrenia Patient and the Possible Mechanism

NCT02552758

Schizophrenia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

essential fatty acids

The experimental treatment is a food supplement containing fish oil. The daily dose of 4 capsules provides 1320 mg of eicosapentaenoic acid and 880 mg of docosahexaenoic acid, 26 weeks intervention

Group Type EXPERIMENTAL

essential fatty acids

Intervention Type DIETARY_SUPPLEMENT

Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)

olive oil

Placebo capsules contain olive oil and trace amount of fish oil to assure comparable taste, 26 weeks intervention

Group Type PLACEBO_COMPARATOR

olive oil

Intervention Type DIETARY_SUPPLEMENT

Yellow capsules containing olive oil (placebo)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

essential fatty acids

Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)

Intervention Type DIETARY_SUPPLEMENT

olive oil

Yellow capsules containing olive oil (placebo)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients diagnosed with schizophrenia using Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria
* Patients aged between 16-35 years
* Signed informed consent (parallel parents consent for individuals under 18 years of age)

Exclusion Criteria

* Patients taking fish oil supplements (a washout period of 6 months is required)
* Patients diagnosed with epilepsy or suffering from epileptic seizures
* Patients receiving anticoagulant medication e.g., Warfarin
* Patients receiving psychotherapy
* Chronic somatic diseases
* Psychoactive substance dependence
* Pregnancy and lactation
* Mental retardation or diagnosed organic brain injury

Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No