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

Phase 1

Active, not recruiting

• Conditions: Clinical High Risk state for developing a first psychotic episode; MedDRA version: 20.0Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 20.0Level: PTClassification code 10061920Term: Psychotic disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2014-003076-22-DE
• Lead Sponsor: Central Institute of Mental Health Mannheim (ZI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-27
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 130

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)

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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 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)
11. Intake of nitroglycerin
Exclusion criteria regarding special restrictions for females:
12. Current pregnancy or pregnancy planned within 9 months after start of medication or nursing women
13. Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
Indication specific exclusion criteria:
14. Having had a psychotic episode for > 1 week (according to SIPS 5.0);
15. Having symptoms relevant for inclusion potentially arising from a known general medical disorder
16. Life time antipsychotic medication for more than 30 days (cumulative number of days) at or above minimum dosage of the '1st episode psychosis' range of DGPPN S3 Guidelines (Exception: maximum dosage for aripiprazole 5 mg/d) (Deutsche Gesellschaft für Psychiatrie, Psychotherapie und Nervenheilkunde, 2006).
17. Any intake of antipsychotic medication (i.e., independent of duration of intake) within the past 3 months before psychopathological baseline assessments (including self-ratings and screening assessments) at or above minimum dosage of the '1st episode psychosis' range of DGPPN S3 Guidelines (Exception: maximum dosage for aripiprazole 5 mg/d) (Deutsche Gesellschaft für Psychiatrie, Psychotherapie und Nervenheilkunde, 2006).
18. Any intake of mood stabilizers (lithium, valproate, carbamazepine, ox-cabazepine, lamotrigine) > 30 days (cumulative number of days) dur-ing the past three months or any intake during the month before psy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified