Multimodal Prevention of First Psychotic Episode – a 2x2-Factorial Randomized Trial investigating the efficacy of Acetylcysteine (ACC) and Integrated Preventive Psychological Intervention (IPPI) in Subjects Clinically at High Risk for Psychosis - ESPRIT B1

Central Institute of Mental Health Mannheim (ZI)0 sites130 target enrollmentNovember 27, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Central Institute of Mental Health Mannheim (ZI)
Enrollment: 130
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 27, 2015

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Central Institute of Mental Health Mannheim (ZI)

Eligibility Criteria

Inclusion Criteria

•Age 18 – 40 years
•Subjects with the ability to follow study instructions and likely to attend and complete all required visits
•Written informed consent of the subject
•Subjects are able to speak, write and understand the German lan\-guage sufficiently well (at the investigators discretion) to complete all required study procedures
•Subjects show impaired social functioning skills as measured by the Global Assessment of Functioning\-Scale (Social) (GFS \= 7\)
•Clinical High Risk Criteria
•Ultra\-high risk criteria (Attenuated Positive Symptoms and/or Brief Limited Intermittend Psychotic Symptoms and/or a com\-bination of familial risk or schizotypal disorder with a significant loss of functioning; assessed by the Structured Interview for Prodromal Syndromes, SIPS 5\.0\)
•The Basic Symptom Criterion 'Cognitive Disturbances, COGDIS' (2/9 cognitive\-perceptive basic symptoms; assessed by the Schizophrenia Proneness Instrument – Adult Version, SPI\-A)
•Are the trial subjects under 18? no
•Number of subjects for this age range:

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 admin\-istration of an investigational medicinal product within 30 days prior to clinical trial beginning. The simultaneous participation in a non\-interventional clinical trial is permitted in case the subject is neverthe\-less 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\. Suicidality in terms of subjects, scoring higher than 0 on the CDSS item 8 'Suicidality'.
•5\. Known substance abuse or dependency within the last month accord\-ing to DSM\-IV\-TR. Patients at least have to be in Early Partial Remis\-sion in order to participate (Patients have met one or more Substance Abuse or Dependency Diagnosis criteria for at least 1 month but less than 12 months. However, the patient has not met all criteria for a dependence or abuse diagnosis)
•6\. Patients with hepatic or renal failure
•7\. Patients with known problems of galactose intolerance, clinically significant lactase deficiency or glucose\-galactose malabsorption or histamine\-intolerance
•8\. Subjects with known asthma bronchiale
•9\. Subjects with a history of gastrointestinal ulcer
•10\. Intake of antitussives (cough\-relieving agents)