Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT00204061
Eligibility Criteria:
Inclusion Criteria:
1. General criteria
* Age between 14 and 36 years
* male or female, in- or outpatients
* written informed consent, for patients below 18 years also signed by parents
2. Special criteria (present within the last three months prior to the study)
* Attenuated Positive Symptoms (APS)
* Presence of at least one of the following symptoms: ideas of reference, odd beliefs or magical thinking, unusual perceptual experiences, odd thinking and speech, suspiciousness or paranoid ideation
* Symptoms have to appear several times per week for a period of at least one week
AND / OR
* Brief Limited Intermittent Psychotic Symptoms (BLIPS)
* Duration of episode less than one week, interval between episodes at least one week
* Symptoms resolve spontaneously
* Presence of at least one of the following symptoms: Hallucinations, Delusions, Formal thought disorder, Gross disorganized or catatonic behavior
Exclusion Criteria:
* Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnosis of schizophrenia, schizophreniform,schizoaffective, delusional or bipolar disorder, at any time of life.
* DSM-IV diagnosis of brief psychotic episode with a duration of more than one week, at any time time of life, or BLIPS within one week before inclusion.
* DSM-IV diagnosis of delirium, dementia, amnestic and other cognitive disorders, mental retardation, mental disorders due to a general medical condition or mental disturbances due to psychotropic substances.
* Abuse of alcohol or drugs within the last three months prior to the study; exception: cannabis user have to be drug-free during four weeks prior to the study. In case of drug abuse, it has to be determined, whether present prodromal symptoms appeared before any drug abuse; If not, symptoms have to be still present after a drug-free period of 3 months (hallucinogens, amphetamines), or four weeks (cannabis).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
36 Years
Study:
NCT00204061
Study Brief:
Protocol Section:
NCT00204061