Prevent: Secondary Prevention of Schizophrenia. A randomized controlled trial.

Phase 1

• Conditions: Persons at risk of being prodromally symptomatic of psychosis (PAR); Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2007-001573-28-DE
• Lead Sponsor: niversität zu Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-06
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Age between 18-49 years
•belong to one or more of the following groups:

(1) Attenuated positive symptoms (APS): Presence of at least one of the following symptoms (SOPS-score 3-5): Unusual thought content/delusional ideas, suspiciousness/persecutory ideas, grandiosity, perceptual abnormalities /hallucinations, disorganized communication
(2) Brief limited intermittent psychotic symptoms (BLIPS): Presence of at least one of the following symptoms ? 7 days resolving spontaneously (SOPS Score=6): Hallucinations, delusions, formal thought disorder
(3) Predictive basic symptoms: Presence of at least two of the nine following symptoms (SPI-A ? 3 ) during the last three months and a presence for more than one year: inability to divide attention, thought interferences, thought pressure, thought blockages, disturbance of receptive speech, disturbance of expressive speech, disturbance in abstract thinking, unstable ideas of reference, captivation of attention by details of the visual field.
(4) Family risk plus reduced functioning: A first-degree relative with a history of any DSM-IV psychotic disorder or DSM-IV schizotypal personality disorder of the index person and a change in mental state or functioning leading to a reduction of 30% or more on the Global Assessment of Functioning (GAF-M) Scale for at least one month within the last year compared to the highest level of previous functioning.
•Verbal IQ>70,
•Written informed consent.

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 380
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Present or past diagnosis of a schizophrenic, schizophreniform, schizoaffective, delusional or bipolar disorder according to DSM IV;
- present or past diagnosis of a brief psychotic disorder according to DSM IV with a duration equal to or of more than one week;
- diagnosis of delirium, dementia, amnestic or other cognitive disorder, mental retardation, autism spectrum disorders;
- psychiatric disorders due to a somatic factor or related to psychotropic substances according to DSM IV;
- present alcohol- or drug dependence according to DSM IV;
- diseases of the central nervous system (inflammatory, traumatic, epilepsy etc.);
- EEG abnormalities;
- current or past antipsychotic treatment without a washout phase of at least 4 weeks;
- current or intended pregnancy, lactation or missing reliable method of contraception;
- current suicidality or dangerous behavior;
- Contraindication accordant SMPC: Known intolerance of the active pharmaceutical ingredient or another ingredient of verum or placebo;
- use of drugs with anticipated interactions (in accordance to SMPC);
- known cardiovascular disease (Myocardial infarct or ischemic heart disease, cardiac insufficiency), cerebrovascular disease, conditions that predispose for hypotonia (dehydration, hypovolemia, treatment with antihypertensive drugs) or hypertonia, known heredity for galactose intolerance, lactase deficit or glucose-galactose-malabsorption;
- participance in other clinical trials, which could intervene with the present trial;
- persons, who are depending on the investigator or the sponsor;
- recent hospitalisation due to legal or regulatory devices;
- persons which have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities

Study & Design

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