Clinical High Risk state for developing a first psychotic episode MedDRA version: 20.0 Level: SOC Classification code 10037175 Term: Psychiatric disorders System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: PT Classification code 10061920 Term: Psychotic disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Acetylcysteine 500 mg capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: N-Acetylcystein (NAC)
Concentration unit: mg milligram(s)
Co
Sponsors
Central Institute of Mental Health Mannheim (ZI)
Eligibility
Sex/Gender
All
Inclusion 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) 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate individual and combined preventive effects of a pharmaceutical intervention with glutamatergic, neuroprotective and anti-inflammatory capabili-ties (ACC) and an integrated preventive psychologcial intervention (IPPI) on transition rates to psychosis, on progression of symptoms and on improvement of social functioning.;Secondary Objective: To evaluate individual and combined preventive effects of a pharmaceutical intervention with glutamatergic, neuroprotective and anti-inflammatory capabili-ties (ACC) and an integrated preventive psychological intervention (IPPI) on improvement of symptoms social cognition and neuropsychological perfor-mance. Tolerability will also be evaluated.;Primary end point(s): •Transition to psychosis within up to 18 months, defined (according to EPOS1) as the presence of at least one psychotic symptom for at least one week (assessed by the SIPS). •Improvement of psychosocial functioning after 18 months (assessed by the SOFAS and the FROGS). ;Timepoint(s) of evaluation of this end point: An interim Analysis of the end points is done when 75% of the planned number of patients (i.e. 98 out of 130) have been randomized. The timepoint cannot be defined, as randomization may vary in the course of the study. Data will be analyzed after Termination of the Trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Remission of symptomatic CHR criteria (APS/BLIPS and/or COGIDS); decrease of positive, negative and disorganization symptoms (as-sessed by the SIPS); improvement of social cognition (SAT-MC I & II, PoFA) •Assessment of safety and tolerability: Neurologic and general exami-nation (medical history, weight, - adverse events (assessed by UKU), Calgary depression rating scale items 1,2,8,9 (CDSS), Laboratory as-sessments ;Timepoint(s) of evaluation of this end point: An interim Analysis of the end points is done when 75% of the planned number of patients (i.e. 98 out of 130) have been randomized. The timepoint cannot be defined, as randomization may vary in the course of the study. Data will be analyzed after Termination of the Trial. | — |
Countries
Germany
Contacts
Public ContactDr. rer. nat. Christine Fuhrmann
Studienzentrale des Studienzentrum Bonn (SZB)
Outcome results
None listed