Status:
COMPLETED
Indicated Prevention With Omega-3 Fatty Acids in Adolescents With 'At-Risk-Mental-State' for Psychosis
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Prodrome
Eligibility:
All Genders
13-25 years
Phase:
PHASE4
Brief 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 cl...
Detailed Description
1. Aims of the study The principal aim is to test if 1.2 g/day EPA/DHA can prevent transition to first-episode psychosis in 13-25 year old ultra-high risk individuals. Specifically we propose to i...
Eligibility Criteria
Inclusion
- /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
- /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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00396643
Start Date
May 1 2004
End Date
June 1 2007
Last Update
December 27 2007
Active Locations (1)
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1
Medical University of Vienna, Department of Child and Adolescent Psychiatry
Vienna, Vienna, Austria, 1090