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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Collaborator: Stanley Medical Research Institute

Criteria

Inclusion Criteria:

1. /written informed consent (for individuals under 18 written informed consent of at least one of the parents is required),

2. /age between 13 and 25 years,

3. /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:

1. /Acute suicidal behaviour, aggressive behaviour (PANSS hostility, suicidality = 7),

2. /Drug abuse that contributed decisively to the presentation of the index episode, (dependency on morphine, cocaine, amphetamine, but not THC),

3. /Alcohol abuse if considered as major problem,

4. /Epilepsy,

5. /Mental Retardation (IQ<80),

6. /Pregnancy and lactation,

7. /Structural changes in MRI or CT scan (e.g., tumours), expect for enlargement of ventricles or sulci,

8. /Previous history of antipsychotic drug (>1 week) or mood stabilizer treatment,

9. /Laboratory values more than 10% outside the normal range for transaminases, CRP or bleeding parameters,

10. /Individuals with organic brain syndrome,

11. /Individuals who are taking anticoagulants,

12. /Individuals who are taking omega 3 supplements, currently or within 8 weeks of being included in the trial,

13. /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.