Primary prevention of psychosis through interventions in the prodromal phase

Not Applicable

Completed

• Conditions: First episode psychosis, schizophrenia/prodromal, ultra-high risk state/primary prevention; Mental and Behavioural Disorders

• Registration Number: ISRCTN20328848
• Lead Sponsor: Stavanger University Hospital (Norway)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-31
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Incidence study inclusion criteria:
1. The patient is listed in the national register and residing in the catchment areas of Stavanger, Fonna, Bergen, and Østfold
2. Between 13 and 65 years
3. Meet diagnostic criteria in DSM-IV for first episode schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, affective psychoses (Bipolar I disorder, Bipolar II disorder with psychotic symptoms, Major depressive disorder with psychotic symptoms) or psychotic disorders NOS
4. The patient is (or has recently been) active psychotic with symptoms of delusions, hallucinations, disturbed thinking, unsuitable/bizarre behaviour which cannot clearly be explained by organic reasons. The symptoms must have lasted the whole day for several days or several times a week for several weeks, not limited to some brief moments corresponding to a score of at least 4 on one or more of the following positive and negative symptom scale (PANSS) symptoms: P1 (delusions), P3 hallucinations), P5 (grandiose thinking), P6 (suspiciousness) and G9 (unusual thought content); 5. This is the first episode of the condition that is being adequately treated. i.e. the patient has not received antipsychotic treatment corresponding to 75% of a defined daily dosage for more than eight weeks (shorter if the symptoms remit)
6. There are no known neurological or endocrine disorders that may have caused the presenting psychotic symptoms
7. The patient is not mentally retarded with an IQ below 70
8. Able to understand and speak Norwegian
9. Able to understand and sign informed consent/assent for minors' document.
Prodromal inclusion and exclusion criteria
1. The patient is listed in the national register and residing in the catchment areas of: Stavanger and Fonna
2. Between 13 and 65 years
3. Meet diagnostic criteria for prodromal syndrome SIPS criteria
4. Does not meet current or life-time criteria for any psychotic disorder
5. The symptoms are not better accounted for by an axis I, axis II or substance use disorder with the exception of schizotypal personality disorder (the presence of any of these disorders in itself is not an automatic reason for exclusion)
6. Does not use any antipsychotic medication currently and have not used antipsychotic medication (regardless of dosage) for more than four weeks lifetime
7. No known neurological or endocrine disorders that may have caused the presenting psychotic symptoms
8.The patient is not mentally retarded with an IQ below 70
9. The patient must be able to understand and speak Norwegian
10. The patient must be able to understand and sign an informed consent or assent for minors' document

Exclusion Criteria

All referals not fullfilling inclusion criteria described above

Study & Design

• Study Type: Interventional
• Study Design: Not specified