DRKS00010952
Recruiting
Phase 3
Multimodal Prevention of First Psychotic Episode – a 2x2-Factorial Randomized Trialinvestigating the efficacy of N-Acetylcysteine (NAC) and Integrated Preventive PsychologicalIntervention (IPPI) in Subjects Clinically at High Risk for Psychosis - ESPRIT B1
Zentralinstitut für seelische Gesundheit/Central Institute of Mental Health (ZI)0 sites200 target enrollmentAugust 16, 2016
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Subjects presenting ultra-high risk (UHR) for psychosis (e.g. attenuated psychotic symptoms, brief limited intermittend psychotic symptoms or a genetic risk in combination with a decline in social functioning)
- Sponsor
- Zentralinstitut für seelische Gesundheit/Central Institute of Mental Health (ZI)
- Enrollment
- 200
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age 18 – 40 years;
- •2\. Subjects with the ability to follow study instructions and likely to attend and complete all required visits;
- •3\. Written informed consent of the subject;
- •4\. Subjects are able to speak, write and understand the German language sufficiently well (at the investigators discretion) to complete all required study procedures;
- •Specific inclusion criterion:
- •5\.Clinical High Risk Criteria : ESPRIT Ultra\-high risk criteria (Attenuated Positive Symptoms and/or Brief Llimited Intermittend Psychotic Symptoms and/or a combination of familial risk or schizotypal disorder with a significant loss of functioning; severity assessed by the Structured Interview for Prodromal Syndromes, SIPS 5\.0\)
- •and/or The Basic Symptom Criterion 'Cognitive Disturbances, COGDIS' (2/9 cognitive\-perceptive basic symptoms; assessed by the Schizophrenia
- •Proneness Instrument – Adult Version, SPI\-A)
Exclusion Criteria
- •1\. Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure;
- •2\. Simultaneously participation in another clinical trial involving administration
- •of an investigational medicinal product within 30 days prior to clinical trial beginning. The simultaneous participation in a noninterventional clinical trial is permitted in case the subject is nevertheless
- •able and willing to attend and complete all required visits and in case there are no other contraindications;
- •3\. Subjects with a physical or psychiatric condition which at the investigator’s
- •discretion may put the subject at other clinically significant risks than those that are defined as outcome of this study (development of a
- •first psychotic episode, functional deterioration), may confound the trial
- •results, or may interfere with the subject’s per protocol participation in
- •this clinical trial;
- •4\. Acute Suicidality;
Outcomes
Primary Outcomes
Not specified
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