EUCTR2007-001573-28-DE
Active, not recruiting
Phase 1
Prevent: Secondary Prevention of Schizophrenia. A randomized controlled trial. - PREVENT
niversität zu Köln0 sitesMarch 6, 2008
ConditionsPersons at risk of being prodromally symptomatic of psychosis (PAR)Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
DrugsAbilify
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Persons at risk of being prodromally symptomatic of psychosis (PAR)
- Sponsor
- niversität zu Köln
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
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;
Outcomes
Primary Outcomes
Not specified
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