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

NCT02210962 | Unknown Phase 4 DMC

• 1 other identifier: N N402 243435
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

early psychosis; chronic schizophrenia; first episode psychosis; omega-3 and omega-6 essential fatty acids; relapse prevention; efficacy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• 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

• 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

Other Outcomes (5)

• 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)

  Baseline, 1, 2, 4, 6, 8, 26 and 52 weeks

Study Arms (2)

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

Dietary Supplement: essential fatty acids

olive oil

PLACEBO COMPARATOR

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

Dietary Supplement: olive oil

Interventions

essential fatty acids DIETARY_SUPPLEMENT

Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)

essential fatty acids

olive oil DIETARY_SUPPLEMENT

Yellow capsules containing olive oil (placebo)

olive oil

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Department of Affective and Psychotic Disorders Medical University of Lodz

Lodz, Łódź Voivodeship, 92216, Poland

Location

Related Publications (1)

• 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.

  PMID: 25934131 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Fatty Acids, Essential; Olive Oil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Fatty Acids, Unsaturated; Fatty Acids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Tomasz P Pawełczyk, MD, PhD

  Department of Affective and Psychotic Disorders Medical University of Lodz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 7, 2014
• Study Start: September 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 18, 2015

Record last verified: 2015-02

Locations

PL (1)