Omega-3 Fatty Acids Efficacy in First-episode of Schizophrenia (OFFER)

February 16, 2015 updated by: Tomasz Pawelczyk, Medical University of Lodz

Omega-3 Fatty Acids in First-episode Schizophrenia - a Randomized Controlled Study of Efficacy and Relapse Prevention (OFFER). Rationale, Design, and Methods.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland, 92216
        • Department of Affective and Psychotic Disorders Medical University of Lodz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Dietary supplement: essential fatty acids
Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)
Placebo Comparator: olive oil
Placebo capsules contain olive oil and trace amount of fish oil to assure comparable taste, 26 weeks intervention
Dietary supplement: olive oil
Yellow capsules containing olive oil (placebo)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary outcome measure will be the efficacy of n-3 PUFA in reducing psychopathology in first-episode schizophrenia.
Time Frame: 8 and 26 weeks of supplementation
The Positive and Negative Syndrome Scale [64] will be used to assess the efficacy of EPA+DHA supplementation in reducing symptom severity in first-episode schizophrenia after 8 and 26 weeks of supplementation. The main outcome measure will be the change in symptom severity from baseline to week 26. Baseline PANSS total score will be subtracted from PANSS score obtained after 26 weeks, resulting in the degree of change observed in the study.
8 and 26 weeks of supplementation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Relapse rate - Positive and Negative Syndrome Scale (PANSS) defined schizophrenia relapse
Time Frame: 26 weeks intervention plus 26 weeks observation
26 weeks intervention plus 26 weeks observation
PANSS total, positive, negative and general psychopathology subscales
Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Clinical Global Impression (CGI)
Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Global Assessment of Functioning (GAF)
Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
A white matter directional organization metric: fractional anisotropy (FA) measured in two areas: corpus callosum and uncinate fasciculus
Time Frame: Baseline, 26 weeks
Baseline, 26 weeks
Cognitive performance using composite battery of neuropsychologic tests
Time Frame: Baseline, 8 and 26 weeks
Baseline, 8 and 26 weeks
Niacin Flush Skin Test
Time Frame: Baseline, 8 and 26 weeks
Baseline, 8 and 26 weeks
Side effects profile according to self-prepared questionnaire
Time Frame: Baseline, 4, 8, 26
Baseline, 4, 8, 26
Lymphocyte telomerase activity
Time Frame: Baseline, 8 and 26 weeks
Baseline, 8 and 26 weeks
Equivalent doses of antipsychotics used
Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26 and 52 weeks
Baseline, 1, 2, 4, 6, 8, 16, 26 and 52 weeks
Grey matter volume: a voxel based structural MRI assessment
Time Frame: Baseline, 8 and 26 weeks
Baseline, 8 and 26 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Plasma cholesterol and Triglycerides
Time Frame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
Blood pressure
Time Frame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
Body mass index (BMI)
Time Frame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
Waist circumference
Time Frame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks
Fasting glucose levels
Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Lodz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tomasz P Pawełczyk, MD, PhD, Department of Affective and Psychotic Disorders Medical University of Lodz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N N402 243435

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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