"Multimodal Prevention of Psychosis - Investigating Efficacy of N-Acetylcysteine and Psychotherapy in CHR-Patients"

Summary

Schizophrenia is a severe mental disorder associated with significant impairments in affective, cognitive and social functioning. Consequently, a special interest in the prevention of schizophrenia and psychotic disorders has emerged. Pharmacological as well as psychological interventions show promising preventive effects. The purpose of this multicentric study is the investigation of possible preventive effects of a treatment combination containing a psychotherapy form and medication (N-Acetylcytein - NAC) in individuals with an enhanced risk for developing schizophrenia. Both treatment forms may reduce the risk in this population due to their specific properties: The psychotherapy can improve social skills, whereas NAC is supposed to develop its protective effects on neuronal level due to its antiinflammatory properties. The investigators will examine the preventive effects by measuring transition rates to psychosis after treatment as well as improvements in social, affective and cognitive functioning.

Conditions

• Prodromal Schizophrenia

Interventions

DRUG

N-Acetylcysteine

N-Acetylcysteine (2000 mg/d, 1000 mg in the morning/evening, oral intake). Will be applied continously over 26 weeks parallel to the psychological intervention (IPPI or PSM).

DRUG

Placebo

Will be applied continously over 26 weeks (oral intake of capsules) parallel to the psychological intervention (IPPI or PSM).

BEHAVIORAL

IPPI (Integrated Preventive Psychological Intervention)

IPPI (Integrated Preventive Psychological Intervention): 21 sessions, the first 20 sessions are scheduled weekly, the last session two weeks after session 20. Single blinded (statistician \& rater)

BEHAVIORAL

PSM (Psychological stress management)

PSM (Psychological stress management): 11 sessions; the first 10 sessions will be offered biweekly, the last one 2 weeks after session 10. Single blinded (statistician \& rater).

Sponsors & Collaborators

• University of Cologne

  collaborator OTHER

• Central Institute of Mental Health, Mannheim

  collaborator OTHER

• Ludwig-Maximilians - University of Munich

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• RWTH Aachen University

  collaborator OTHER

• University Hospital, Bonn

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-01

Primary Completion

2021-01-31

Completion

2021-01-31

Countries

• Germany

Study Locations