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Trial record 55 of 3313 for:    schizophrenia

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

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ClinicalTrials.gov Identifier: NCT02210962
Recruitment Status : Unknown
Verified February 2015 by Tomasz Pawelczyk, Medical Universtity of Lodz.
Recruitment status was:  Active, not recruiting
First Posted : August 7, 2014
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Tomasz Pawelczyk, Medical Universtity of Lodz

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Dietary Supplement: essential fatty acids Dietary Supplement: olive oil Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Omega-3 Fatty Acids in First-episode Schizophrenia - a Randomized Controlled Study of Efficacy and Relapse Prevention (OFFER). Rationale, Design, and Methods.
Study Start Date : September 2011
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Relapse rate - Positive and Negative Syndrome Scale (PANSS) defined schizophrenia relapse [ Time Frame: 26 weeks intervention plus 26 weeks observation ]
  2. PANSS total, positive, negative and general psychopathology subscales [ Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks ]
  3. Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks ]
  4. Clinical Global Impression (CGI) [ Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks ]
  5. Global Assessment of Functioning (GAF) [ Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks ]
  6. A white matter directional organization metric: fractional anisotropy (FA) measured in two areas: corpus callosum and uncinate fasciculus [ Time Frame: Baseline, 26 weeks ]
  7. Cognitive performance using composite battery of neuropsychologic tests [ Time Frame: Baseline, 8 and 26 weeks ]
  8. Niacin Flush Skin Test [ Time Frame: Baseline, 8 and 26 weeks ]
  9. Side effects profile according to self-prepared questionnaire [ Time Frame: Baseline, 4, 8, 26 ]
  10. Lymphocyte telomerase activity [ Time Frame: Baseline, 8 and 26 weeks ]
  11. Equivalent doses of antipsychotics used [ Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26 and 52 weeks ]
  12. Grey matter volume: a voxel based structural MRI assessment [ Time Frame: Baseline, 8 and 26 weeks ]

Other Outcome Measures:
  1. Plasma cholesterol and Triglycerides [ Time Frame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks ]
  2. Blood pressure [ Time Frame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks ]
  3. Body mass index (BMI) [ Time Frame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks ]
  4. Waist circumference [ Time Frame: Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks ]
  5. Fasting glucose levels [ Time Frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210962


Locations
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Poland
Department of Affective and Psychotic Disorders Medical University of Lodz
Lodz, Poland, 92216
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
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Principal Investigator: Tomasz P Pawełczyk, MD, PhD Department of Affective and Psychotic Disorders Medical University of Lodz

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tomasz Pawelczyk, Assistant Professor, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT02210962     History of Changes
Other Study ID Numbers: N N402 243435
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015
Keywords provided by Tomasz Pawelczyk, Medical Universtity of Lodz:
early psychosis
chronic schizophrenia
first episode psychosis
omega-3 and omega-6 essential fatty acids
relapse prevention
efficacy
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders