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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| essential fatty acids | Experimental | 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 |
|
| olive oil | Placebo Comparator | Placebo capsules contain olive oil and trace amount of fish oil to assure comparable taste, 26 weeks intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| essential fatty acids | Dietary Supplement | Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure will be the efficacy of n-3 PUFA in reducing psychopathology in first-episode schizophrenia. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse rate - Positive and Negative Syndrome Scale (PANSS) defined schizophrenia relapse | 26 weeks intervention plus 26 weeks observation | |
| PANSS total, positive, negative and general psychopathology subscales | Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma cholesterol and Triglycerides | Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks | |
| Blood pressure | Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks | |
| Body mass index (BMI) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz P Pawełczyk, MD, PhD | Department of Affective and Psychotic Disorders Medical University of Lodz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Affective and Psychotic Disorders Medical University of Lodz | Lodz | Łódź Voivodeship | 92216 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25934131 | Derived | Pawelczyk T, Grancow M, Kotlicka-Antczak M, Trafalska E, Gebski P, Szemraj J, Zurner N, Pawelczyk A. Omega-3 fatty acids in first-episode schizophrenia - a randomized controlled study of efficacy and relapse prevention (OFFER): rationale, design, and methods. BMC Psychiatry. 2015 May 2;15:97. doi: 10.1186/s12888-015-0473-2. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005228 | Fatty Acids, Essential |
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
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| olive oil | Dietary Supplement | Yellow capsules containing olive oil (placebo) |
|
| Calgary Depression Scale for Schizophrenia (CDSS) | Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks |
| Clinical Global Impression (CGI) | Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks |
| Global Assessment of Functioning (GAF) | 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 | Baseline, 26 weeks |
| Cognitive performance using composite battery of neuropsychologic tests | Baseline, 8 and 26 weeks |
| Niacin Flush Skin Test | Baseline, 8 and 26 weeks |
| Side effects profile according to self-prepared questionnaire | Baseline, 4, 8, 26 |
| Lymphocyte telomerase activity | Baseline, 8 and 26 weeks |
| Equivalent doses of antipsychotics used | Baseline, 1, 2, 4, 6, 8, 16, 26 and 52 weeks |
| Grey matter volume: a voxel based structural MRI assessment | Baseline, 8 and 26 weeks |
| Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks |
| Waist circumference | Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks |
| Fasting glucose levels | Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks |
| D004041 |
| Dietary Fats |
| D005223 | Fats |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |