Indicated Prevention With Omega-3 Fatty Acids in Adolescents With 'At-Risk-Mental-State' for Psychosis - Full Text View

Sponsor:	Medical University of Vienna
Collaborator:	Stanley Medical Research Institute
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00396643

Purpose

Early intervention in psychosis might be associated with better outcomes. However, intervention in the pre-psychotic phase has been questioned as, using current criteria, only 20-50% of individuals classified as prodromal develop a psychotic disorder within a 1-2 years period. Treatment agents investigated in the pre-psychotic phase of schizophrenia and other psychotic disorders should, therefore, not have major side effects. This proposal investigates omega-3 fatty acids (1.2 gramm per day eicosapentaenoic acid/docosahexaenoic acid;EPA/DHA) as a beneficial and possible preventive therapeutic agent in young people at ultra high-risk for developing a psychotic disorder.

Condition	Intervention	Phase
Schizophrenia Prodrome	Drug: Omega 3 fatty acids	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Indicated Prevention With Omega-3 Fatty Acids in Adolescents With 'At-Risk-Mental-State' for Psychosis: A Randomised, Double Blind, Placebo-Controlled Treatment Trial

Resource links provided by NLM:

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Transition to PANSS defined first-episode psychosis [ Time Frame: Baseline, 1, 2, 3, 4, 8, 12 weeks, 6, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PANSS positive, negative, and global subscales [ Time Frame: Baseline, 1, 2, 3, 4, 8, 12 weeks, 6, and 12 months ] [ Designated as safety issue: No ]
MADRS [ Time Frame: Baseline, 1, 2, 3, 4, 8, 12 weeks, 6, and 12 months ] [ Designated as safety issue: No ]
GAF [ Time Frame: Baseline, 1, 2, 3, 4, 8, 12 weeks, 6, and 12 months ] [ Designated as safety issue: No ]
UKU [ Time Frame: Baseline, 1, 2, 3, 4, 8, 12 weeks ] [ Designated as safety issue: Yes ]
Lipid metabolism in peripheral tissue pre/post treatment [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	81
Study Start Date:	May 2004
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Omega 3 fatty acids The active treatment is a supplement of yellow gelatin 0.5 g fish oil capsules. The daily dose of 4 (2x2) capsules provides 700 mg of eicosapentaenoic acid and 500 mg of docosahexaenoic acid, and 10 mg of Vitamin E. Placebo treatment comprises coconut oil capsules, carefully matched with the active treatment with respect to both appearance and flavor, also containing 10 mg Vitamin E, and 10 mg of fish oil to mimic taste. Coconut oil was chosen as placebo because it does not contain polyunsaturated fatty acids and has no impact on n-3 fatty acid metabolism. The intervention period is 12 weeks.
B: Placebo Comparator Coconut oil	Drug: Omega 3 fatty acids The active treatment is a supplement of yellow gelatin 0.5 g fish oil capsules. The daily dose of 4 (2x2) capsules provides 700 mg of eicosapentaenoic acid and 500 mg of docosahexaenoic acid, and 10 mg of Vitamin E. Placebo treatment comprises coconut oil capsules, carefully matched with the active treatment with respect to both appearance and flavor, also containing 10 mg Vitamin E, and 10 mg of fish oil to mimic taste. Coconut oil was chosen as placebo because it does not contain polyunsaturated fatty acids and has no impact on n-3 fatty acid metabolism. The intervention period is 12 weeks.

Arms

Assigned Interventions

A: Experimental

Drug: Omega 3 fatty acids

The active treatment is a supplement of yellow gelatin 0.5 g fish oil capsules. The daily dose of 4 (2x2) capsules provides 700 mg of eicosapentaenoic acid and 500 mg of docosahexaenoic acid, and 10 mg of Vitamin E. Placebo treatment comprises coconut oil capsules, carefully matched with the active treatment with respect to both appearance and flavor, also containing 10 mg Vitamin E, and 10 mg of fish oil to mimic taste. Coconut oil was chosen as placebo because it does not contain polyunsaturated fatty acids and has no impact on n-3 fatty acid metabolism. The intervention period is 12 weeks.

B: Placebo Comparator

Coconut oil

Drug: Omega 3 fatty acids

The active treatment is a supplement of yellow gelatin 0.5 g fish oil capsules. The daily dose of 4 (2x2) capsules provides 700 mg of eicosapentaenoic acid and 500 mg of docosahexaenoic acid, and 10 mg of Vitamin E. Placebo treatment comprises coconut oil capsules, carefully matched with the active treatment with respect to both appearance and flavor, also containing 10 mg Vitamin E, and 10 mg of fish oil to mimic taste. Coconut oil was chosen as placebo because it does not contain polyunsaturated fatty acids and has no impact on n-3 fatty acid metabolism. The intervention period is 12 weeks.

Show Detailed Description

Eligibility

Ages Eligible for Study:	13 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

/written informed consent (for individuals under 18 written informed consent of at least one of the parents is required),
/age between 13 and 25 years,
/ARMS as classified by the PACE criteria (Yung et al., 1998)

PACE criteria for ARMS include one or more of following characteristics which must have occurred within the last 12 months:

Frank psychotic symptoms < 1 week (Transient psychosis group)
Attenuated psychotic symptoms > 1 week, > 2 times per week
Decline in global function (drop in GAF of > 30%) plus family history of psychosis or individual has schizotypal personality disorder To operationalize PACE criteria duration and severity ratings of psychotic symptoms will be performed using the Positive and Negative Syndromes of Schizophrenia Scale (PANSS) (Kay et al., 1987) applying following cut-off scores, following Morrison et al (2002): Ad 1) Transient psychosis is defined with the presence of symptoms that score 4 or more on hallucinations, 4 or more on delusions, or 5 or more on conceptual disorganizations, last less than one week and resolve without antipsychotic medication. Ad 2) Attenuated psychotic symptoms are defined by the presence of symptoms that score 3 on delusions, 2-3 on hallucinations, 3-4 on suspiciousness or 3-4 on conceptual disorganization.

Exclusion Criteria:

/Acute suicidal behaviour, aggressive behaviour (PANSS hostility, suicidality = 7),
/Drug abuse that contributed decisively to the presentation of the index episode, (dependency on morphine, cocaine, amphetamine, but not THC),
/Alcohol abuse if considered as major problem,
/Epilepsy,
/Mental Retardation (IQ<80),
/Pregnancy and lactation,
/Structural changes in MRI or CT scan (e.g., tumours), expect for enlargement of ventricles or sulci,
/Previous history of antipsychotic drug (>1 week) or mood stabilizer treatment,
/Laboratory values more than 10% outside the normal range for transaminases, CRP or bleeding parameters,
/Individuals with organic brain syndrome,
/Individuals who are taking anticoagulants,
/Individuals who are taking omega 3 supplements, currently or within 8 weeks of being included in the trial,
/Individuals who have other, severe, intercurrent illness which in the opinion of the investigator may put them at risk or influence the results of the trial or affect ability to take part in the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396643

Locations

Austria
Medical University of Vienna, Department of Child and Adolescent Psychiatry
Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Stanley Medical Research Institute

Investigators

Principal Investigator:

G Paul Amminger, MD

Medical University of Vienna

More Information

Additional Information:

The Stanley Medical Research Institute This link exits the ClinicalTrials.gov site

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Amminger GP, Schäfer MR, Papageorgiou K, Klier CM, Cotton SM, Harrigan SM, Mackinnon A, McGorry PD, Berger GE. Long-chain omega-3 fatty acids for indicated prevention of psychotic disorders: a randomized, placebo-controlled trial. Arch Gen Psychiatry. 2010 Feb;67(2):146-54.

Responsible Party:	Medical University of Vienna ( Dr G. Paul Amminger )
ClinicalTrials.gov Identifier:	NCT00396643 History of Changes
Other Study ID Numbers:	SMRI 03T-315, FA765Z0003, EK Nr: 415/2002
Study First Received:	November 6, 2006
Last Updated:	December 20, 2007
Health Authority:	Austria: Ethikkommission; Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:

Ultra-High Risk
Psychosis
Schizophrenia
Omega-3 fatty acids
RCT

Additional relevant MeSH terms:

Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 07, 2010