None listed
Conditions
Brief summary
In recent years, researchers of psychotic disorders, a group of mental disorders that involve a loss of contact with reality and symptoms such as hallucinations and delusions, have focused their attention on studying the early phase of psychotic disorders, referred to as the prodromal phase. The prodromal phase is the period of a psychotic disorder where individuals experience the types of symptoms that are indicative of a psychotic disorder but are not yet of the severity or frequency that constitute a psychotic disorder. Much of the disability associated with psychotic disorders can develop during this phase, and such disability is difficult to reverse once a full psychotic disorder has developed. Hence, researchers are keen to learn more about the prodromal phase of psychotic disorders and investigate treatment strategies that can be applied during this phase with the hope of preventing, delaying or reducing the severity of psychotic disorders. As yet, a clear treatment strategy for this phase of disease has not been established. Researchers have established criteria to define individuals who are 'at risk' of developing a psychotic disorder. These are referred to as the 'ultra high risk' (UHR) criteria. Not all patients who are 'at risk' go on to develop a psychotic disorder; however, the use of such criteria allows researchers to further define the prodromal phase and investigate strategies that may prevent the development of a psychotic disorder. In this study, 320 patients who are 'at risk' of developing a psychotic disorder will be treated with omega-3 fatty acids, naturally occurring molecules found in fish oil, or receive a placebo. In addition to receiving one of these two treatments, all patients will receive a psychological treatment known as cognitive behavioural case management, which is based around standard case management and cognitive behavioural therapy that is routinely delivered by doctors and psychologists. The primary aim of the study is to determine whether omega-3 fatty acids, provided on a background of cognitive behavioural case management, can reduce the incidence of the development of a psychotic disorder in patients who are 'at risk' of developing such a disorder.
Interventions
Omega-3 fatty acids, cognitive behavioural case management. Omega-3 fatty acids: 2.8g of marine fish oil containing approximately 1.4g Eicosapentanoic acid (EPA)/Docosahexaenoic acid (DHA) in 4 X 0.700g capsules, administered orally, daily for 6 months. Cognitive behavioural case management: A manualised intervention of cognitive-behavioural therapy (CBT) embedded within case management will be provided to all participants. Participants will receive 6 – 20 sessions within the first 6 months depe
Omega-3 fatty acids, cognitive behavioural case management. Omega-3 fatty acids: 2.8g of marine fish oil containing approximately 1.4g Eicosapentanoic acid (EPA)/Docosahexaenoic acid (DHA) in 4 X 0.700g capsules, administered orally, daily for 6 months. Cognitive behavioural case management: A manualised intervention of cognitive-behavioural therapy (CBT) embedded within case management will be provided to all participants. Participants will receive 6 – 20 sessions within the first 6 months depending on the participant’s needs (weekly sessions recommended where feasible), and then further sessions on an 'as needs' basis for up to 12 months (from entry). The CBT component of the intervention is built around the stress-vulnerability model of psychosis, as elaborated by authors including P.E. Meehl, I.I. Gottesman and B. Spring, and broken down into three distinct phases of intervention: (i) assessment & engagement (ii) treatment and (iii) termination. Within this model, five modules of therapy are outlined for this study: (i) stress management (ii) depression & negative symptoms (iii) positive symptoms (iv) basic symptoms and (v) other comorbidity. The stress management module will be used for all patients; the other modules are intended to be used as applicable to the patient’s symptoms. Within the specific modules, the specified strategies include psychoeducation, stress monitoring and management, coping techniques and cognitive restructuring. The intervention will also involve a thorough assessment of substance use and the strategies as outlined above will be employed to assist with modifying problematic substance use behaviour. Each session is expected to be of 30-60 minutes duration.
Sponsors
Orygen, The National Centre of Excellence in Youth Mental Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
13 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Ability to give informed consent 2. Age 13 - 40 yrs depending on site 3. Membership of one of the following ‘at-risk’ groups: i. Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a trait risk factor (Schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in mental state and/or functioning or sustained low functioning during the past year. ii. Attenuated Psychotic Symptoms Group (APS) Individuals with subthreshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year and be associated with a significant reduction in or sustained low functioning. iii. Brief Limited Intermittent Psychotic Symptoms Group (BLIPS) Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year and be associated with a significant reduction in or sustained low functioning.
Exclusion criteria
1. Past history of a treated or untreated psychotic episode of one week’s duration or longer. 2. Organic brain disease, e.g. epilepsy, inflammatory brain disease. 3. Abnormal coagulation profile parameters or thyroid function test results >10% above or below the limits of the normal range. 4. Any physical illness with psychotropic effect, if not stabilized. 5. Current treatment with any mood stabiliser, or recreational use of ketamine. 6. Past neuroleptic exposure equivalent to a total lifetime haloperidol dose of >50 mg. 7. Diagnosis of a serious developmental disorder, e.g. Asperger's syndrome. 8. Premorbid IQ < 70 and a documented history of developmental delay or intellectual disability. 9. Current aggression/dangerous behaviour (CAARMS 5.4 severity score 6) 10. Current suicidality/self harm (CAARMS 7.3 severity score 6) 11. Current pregnancy. 12. Current attenuated symptoms that are entirely explained by acute intoxication (e.g., current attenuated symptoms entirely explained by LSD use). 13. More than 4 weeks of regular omega-3 supplementation (>2 capsules standard strength providing >600 mg combined EPA/DHA) within the last 6 months.
Outcome results
None listed