Indicated Prevention With Long-chain Polyunsaturated Omega-3 Fatty Acids in Patients With 22q11 Microdeletion Syndrome.

NCT02070211 | Unknown Phase 2 DMC

• 2 other identifiers: APS 121278
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

22q11 Deletion Syndrome

Keywords

Psychotic Disorder; 22q11 Deletion Syndrome; Fatty Acids, Omega-3

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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

Study Arms (2)

omega-3 PUFAs in add on to standard care

EXPERIMENTAL

omega-3 PUFA supplementation as an adjunct to non-neuroleptic, standard therapy in individuals with 22q11DS and UHR criteria for psychosis

Dietary Supplement: omega-3 PUFAs; Other: Standard care

Placebo in add on to standard care

PLACEBO COMPARATOR

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

Other: Standard care; Dietary Supplement: placebo

Interventions

omega-3 PUFAs DIETARY_SUPPLEMENT

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.

Also known as: fish oil, poly unsaturated fatty acids

omega-3 PUFAs in add on to standard care

Standard care OTHER

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.

Placebo in add on to standard care; omega-3 PUFAs in add on to standard care

placebo DIETARY_SUPPLEMENT

4 capsules of 0.7g of paraffin oil (which is not absorbed by the gastrointestinal tract) per day.

Placebo in add on to standard care

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• written informed consent (for individuals under 18 written informed consent of parents is required);
• age between 12 and 26 years;
• UHR as classified by the CAARMS (Yung et al., 2005);
• genetic diagnosis of 22q11DS

You may not qualify if:

• acute suicidal behaviour (score of 6 on CAARMS item 7.3) or aggressive behaviour (score of 6 on CAARMS item 5.4);
• 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; 5./IQ\<70);
• Pregnancy and lactation;
• Previous history of antipsychotic drug treatment (\> one week treatment);
• Laboratory values more than 15% 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.

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator
• Orygen: collaborator

Study Sites (1)

Bambino Gesù Hospital and Research Institute

Vatican City, Vatican City State, 00165, Holy See

Location

MeSH Terms

Conditions

22q11 Deletion Syndrome; Psychotic Disorders

Interventions

Fish Oils; Standard of Care

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Lymphatic Abnormalities; Lymphatic Diseases; Hemic and Lymphatic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Hypoparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marco Armando, MD, PhD

  Bambino Gesù Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Armando, MD, PhD

CONTACT

+39 06 6859 2030; marco.armando@opbg.net

Stefano Vicari, MD, PhD

CONTACT

+39 06 6859 2453; stefano.vicari@opbg.net

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: MD, PhD

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 25, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

HO (1)