Schizophrenia
Conditions
Keywords
early psychosis, chronic schizophrenia, first episode psychosis, omega-3 and omega-6 essential fatty acids, relapse prevention, efficacy
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTessential fatty acids
Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)
DIETARY_SUPPLEMENTolive oil
Yellow capsules containing olive oil (placebo)
Sponsors
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measure will be the efficacy of n-3 PUFA in reducing psychopathology in first-episode schizophrenia. | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Global Assessment of Functioning (GAF) | Baseline, 1, 2, 4, 6, 8, 16, 26, 52 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 |
| Calgary Depression Scale for Schizophrenia (CDSS) | Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks |
| 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 |
| Clinical Global Impression (CGI) | 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 |
Other
| Measure | Time frame |
|---|---|
| Blood pressure | Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks |
| Body mass index (BMI) | 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 |
| Plasma cholesterol and Triglycerides | Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks |
Countries
Poland
Outcome results
None listed