Psychoses Clinical Trial
Official title:
Access, Detection and Psychological Treatments
Verified date | October 2007 |
Source | Ontario Mental Health Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Schizophrenia is one of society's most costly medical conditions and the most severe among psychiatric disorders. One of the most important and exciting new concepts in psychiatry is that detection and intervention very early in the course of schizophrenia offers what may be the field's best practical hope for realizing substantive improvements in the outcome of schizophrenia or schizophrenia spectrum disorders. Thus, we propose a five year program that focuses on three interconnected major research streams: (1) an evaluation of the effectiveness and cost-effectiveness of a model-driven psychological intervention in preventing or delaying the onset of a psychotic illness; (2) a qualitative study of the pathways to mental health at this time of very high risk; and (3) an exploration of the burden to the healthcare and informal caregiver systems associated with this high risk population.
Status | Active, not recruiting |
Enrollment | 56 |
Est. completion date | August 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Ages 12-30 years· - Meeting criteria for an "at risk mental state" based on one or more of the 3 Criteria of Prodromal Symptoms (COPS criteria) with severity as determined by ratings on the Scale of Prodromal Symptoms (SOPS) or the criteria for attenuated symptoms of the early prodromal state defined by the presence of at least two of 9 symptoms on the Bonn Scale for the Assessment of Basic Symptoms that have been demonstrated to have the best positive predictive value of developing schizophrenia (Klosterkötter et al., 2001). These criteria for the early prodromal state course are currently used in the multi-site European Prediction of Psychosis Study (EPOS) (Birchwood et al., 2002). Exclusion Criteria: - Meets criteria for current or lifetime axis I psychotic disorder.· - Meets DSM-IV criteria for an Axis 1 disorder where in the judgment of the evaluating clinician the diagnostic prodromal symptoms are clearly caused by the Axis 1 disorder. Note that, except for bipolar and psychotic disorders and a current major depression other DSM-IV disorders will not be exclusionary (e.g. substance abuse or dependence disorder, major depression, anxiety disorders, Axis II Disorders) as long as the disorder does not account for the diagnosis of prodromal symptoms.· - Use of substances where in the judgment of the evaluating clinician, the diagnostic prodromal symptoms are substance-induced. - Prior history of treatment with an antipsychotic for the current presenting symptoms or for any previous episode of psychotic symptoms. - Impaired intellectual functioning (IQ< than 70). - Past or current history of a clinically significant central nervous system disorder which may confound or contribute to prodromal symptoms. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ontario Mental Health Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Research Stream 1: Treatment and Cost Effectiveness Primary outcome measure: (i) Time to conversion. | 18 months | ||
Primary | Research Stream 2: Pathways to Care Primary outcome measure: Pathway to care interview | 18 months | ||
Primary | Research Stream 3: Costs of Caring in Psychosis Primary outcome measure: (i) Time to conversion, (ii) costs of formal and informal care giving. | 18 months |
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