Secondary PREVENTion of schizophrenia: a randomised controlled trial

Not Applicable

Completed

• Conditions: Prodromal schizophrenia; Mental and Behavioural Disorders; Schizotypal disorder

• Registration Number: ISRCTN02658871
• Lead Sponsor: niversity of Cologne (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-05
• Study Completion: 2014-10-31
• Last Update Posted: 8 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Current participant inclusion criteria as of 19/03/2019:
1. Aged between 18 - 49 years
2. Belong to one of the following groups:
2.1. Attenuated Positive Symptoms (APS)
2.2. Brief Limited Intermittent Psychotic Symptoms (BLIPS)
2.3. Predictive basic symptoms
2.4. Family risk plus reduced functioning
3. Verbal Intelligence Quotient (IQ) greater than 70
4. Written informed consent

Previous participant inclusion criteria:
1. Aged between 18 - 40 years
2. Belong to one of the following groups:
2.1. Attenuated Positive Symptoms (APS)
2.2. Brief Limited Intermittent Psychotic Symptoms (BLIPS)
2.3. Predictive basic symptoms
2.4. Family risk plus reduced functioning
3. Verbal Intelligence Quotient (IQ) greater than 70
4. Written informed consent

Exclusion Criteria

1. Present or past diagnosis of a schizophrenic, schizophreniform, schizoaffective, delusional or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
2. Present or past diagnosis of a brief psychotic disorder according to DSM IV with a duration equal to or of more than one week or within the last 4 weeks regardless of its duration
3. Diagnosis of delirium, dementia, amnestic or other cognitive disorder, mental retardation, autism spectrum disorders, psychiatric disorders due to a somatic factor or related to psychotropic substances according to DSM IV
4. Alcohol or drug dependence according to DSM IV
5. Diseases of the central nervous system (inflammatory, traumatic, epilepsy etc.)
6. Magnetic Resonance Imaging (MRI) or Electroencephalogram (EEG) abnormalities
7. Current or past antipsychotic treatment for longer than 1 week
8. Current or past antipsychotic treatment shorter than 1 week without a washout phase of at least 4 weeks
9. Current pregnancy, lactation or missing reliable method of contraception
10. Current suicidality or dangerous behaviour
11. Contraindication according to Summary of Product Characteristics (SmPC): known intolerance of the active pharmaceutical ingredient or another ingredient of verum or placebo
12. Use of drugs with anticipated interactions (in accordance to SmPC)
13. Participance in other clinical trials, which could intervene with the present trial
14. Persons who are depending on the investigator or the sponsor
15. Hospitalisation due to legal or regulatory devices

Study & Design

• Study Type: Interventional
• Study Design: Not specified