NCT02070211|UnknownPhase 2/3DMC
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · NARSAD Young Investigator Grant
interventional
80
1 country
1
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of the present trial is to investigate the effects of omega-3 PUFAs in individuals aged 12-26 years with 22q11DS at ultra-high risk for developing a first episode of psychosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 17, 2014
Actual (reported)February 25, 2014
Actual (reported)June 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The primary outcome measure for this study is the transition to psychosis rate measured by the Comprehensive Assessment of At Risk Mental States (CAARMS) (Yung et al., 2005),
Transition to psychosis is operationally defined, based on the CAARMS (Yung et al., 2005) criteria: 1./Abnormal thoughts held with delusional intensity occurring every day for one week or longer; 2./True hallucinations in any modality occurring every day for one week or longer; or 3./Formal thought disorder to the degree of incoherence and/or loose associations occurring every day for one week or longer
The time frame for the first outcome measure will be over the 12-month follow-up period.
The secondary outcome measures are the transition to psychosis rate measured by the CAARMS, the Positive and Negative Syndrome Scale (PANSS), the Montgomery-Asberg Depression Rating Scale (MADRS) and the Global Assessment of Functioning Scale (GAF)
These scales will be performed at baseline, 4, 8, 12, 26, and 52 weeks.
Side effects of therapeutic interventions will be assessed using the UKU side effect rating scale (Lingjaerde et al., 1987).
Side effects will be assessed at baseline, 4, 8, 12, 26, and 52 weeks
Wechsler Adult Intelligence Scales-Revised, the Wechsler Memory Scale-Revised, the Wisconsin Card Sorting Test, Trail Making Test-Part A and B, the Continuous Performance Test, and the Finger Tapping Test: right and left
The neuropsychological battery will be performed at baseline and after 12 weeks (pre/post study design) and at 12 months follow-up.
Blood samples: EDTA blood in standard glass tubes (no plastic tubes because of artifacts for omega-3 PUFA analysis)
At baseline and after twelve weeks
omega-3 PUFA supplementation as an adjunct to non-neuroleptic, standard therapy in individuals with 22q11DS and UHR criteria for psychosis
Placebo made by paraffin oil (not absorbed by the gastrointestinal tract) as an adjunct to non-neuroleptic, standard therapy in individuals with 22q11DS and UHR criteria for psychosis
4 capsules (2 in the morning; 2 in the evening) for a period of 12 weeks. The active treatment is a supplement of yellow gelatine 0.625 g capsules containing concentrated marine fish oil. The daily dose of 4 capsules will provide approximately 700 mg of eicosapentaenoic acid (EPA, 20:5n3), 480 mg of docosahexaenoic acid (DHA, 22:6n3), and 7.6 mg of Vitamin E.
Bambino Gesù Hospital and Research Institute
Vatican City, Vatican City State, 00165, Holy See
Marco Armando, MD, PhD
Bambino Gesù Hospital and Research Institute
First Submitted
February 17, 2014
First Posted
February 25, 2014
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Standard care includes management by a psychiatrist or resident psychiatrist and non-neuroleptic pharmacotherapy as clinically indicated. Specifically, Cognitive-behavioural therapy (CBT) embedded within case management will be administered. The CBT will be based on the models developed at the PACE Clinic in Melbourne, in the EDIE trial, and in Cologne, as these have proven to be effective in RCTs. The number of sessions delivered will be captured for each client. In addition, fidelity will be monitored by therapists rating their own sessions on an established checklist of therapeutic interventions.
4 capsules of 0.7g of paraffin oil (which is not absorbed by the gastrointestinal tract) per day.
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June 2016
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 25, 2014
Record last verified: 2014-02
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