Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
Recruitment status was Active, not recruiting
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Purpose
The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is that the combination of a clinical management with an atypical neuroleptic is the superior treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Psychoses |
Behavioral: Clinical Management (CM) Drug: Amisulpride |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
- improvement of prodromal symptoms (ERIRAOS-Scale, PANSS)
- social impairment
- social functioning (GAF)
- depression
| Estimated Enrollment: | 130 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | June 2005 |
The first diagnosis of schizophrenia is preceded by a long lasting period comprising an untreated psychotic and a prodromal state. The duration of untreated psychosis correlates with a significant worsening of several outcome variables and persons fulfilling criteria of a prodromal state are already suffering from prodromal symptoms and from a significant deterioration of social and vocational functioning. However, a sufficient strategy for early intervention is still lacking. The study will provide an empirical basis for a pharmacological treatment option. An open-label, randomized, multi-centre parallel group design is used. An intensified clinical management (CM), which allows needs-based psychological crisis intervention, is compared to a combination of such a CM and the atypical neuroleptic amisulpride. For analysis 130 patients will be recruited within three years, the treatment period is two years.
Eligibility| Ages Eligible for Study: | 14 Years to 36 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
Special criteria (present within the last three months prior to the study)
- Attenuated Positive Symptoms
- Presence of at least one of the following symptoms (assessed by ERIraos):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 (assessed by ERIraos): Hallucinations, Delusions, Formal thought disorder, Gross disorganized or catatonic behavior
Exclusion Criteria:
- 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 psy-chotropic 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).
Contacts and Locations| Germany | |
| Department of Psychiatry and Psycotherapy University of Cologne | |
| Cologne, North Rhine-Westphalia, Germany, 50924 | |
| Study Chair: | Joachim Klosterkötter, Professor | Department of Psychiatry and Psycotherapy University of Cologne |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00204061 History of Changes |
| Other Study ID Numbers: | 01 GI 9935 - P 1.1.3 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Cologne:
|
schizophrenia psychosis ultra high risk |
prodromal state early intervention amisulpride |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Sultopride Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013