Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
This study has been completed.
Sponsor:
University of Cologne
Collaborators:
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Sanofi-Synthelabo
Department of Psychiatry University of Bonn
Heinrich-Heine University, Duesseldorf
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Stephan Ruhrmann, University of Cologne
ClinicalTrials.gov Identifier:
NCT00204061
First received: September 12, 2005
Last updated: December 23, 2014
Last verified: December 2014
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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: Supportive management 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 |
| Official Title: | Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis |
Resource links provided by NLM:
Further study details as provided by University of Cologne:
Primary Outcome Measures:
- improvement of risk related symptoms [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]Decrease of symptom scores; complete remission of risk related symptoms
Secondary Outcome Measures:
- Global functioning [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]Increase of Global Assessment of Functioning (GAF) scores
| Enrollment: | 124 |
| Study Start Date: | January 2001 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: supportive management
needs-focused, unspecific supportive management
|
Behavioral: Supportive management
The needs-focused intervention could include psychoeducation, crisis intervention, family counselling and assistance with education or work-related difficulties, according to need. Regular psychotherapy was not permitted.
Other Name: Clinical Management
|
|
Experimental: amisulpride
24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management.
|
Drug: Amisulpride
Daily doses could range from 50 to 800 mg, with increments of 50 mg at first step and 100 mg at further steps. As a guideline, it was suggested that the dosage be increased as long as attenuated or brief limited intermittent positive symptoms were present. The interval between such steps should be at least 14 days if brief limited symptoms were absent and the APS score had improved.
Other Name: Solian
|
Detailed Description:
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 |
Criteria
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 (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).
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204061
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204061
Locations
| Germany | |
| Department of Psychiatry and Psycotherapy University of Cologne | |
| Cologne, North Rhine-Westphalia, Germany, 50924 | |
Sponsors and Collaborators
University of Cologne
German Federal Ministry of Education and Research
German Research Network On Schizophrenia
Sanofi-Synthelabo
Department of Psychiatry University of Bonn
Heinrich-Heine University, Duesseldorf
Ludwig-Maximilians - University of Munich
Investigators
| Study Chair: | Joachim Klosterkötter, Professor | Department of Psychiatry and Psycotherapy University of Cologne |
More Information
Additional Information:
No publications provided
| Responsible Party: | Stephan Ruhrmann, Deputy Head of the Department of Psychiatry, University of Cologne |
| 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: | December 23, 2014 |
| 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 and Disorders with Psychotic Features Sultopride Antipsychotic Agents Central Nervous System Agents Central Nervous System Depressants Dopamine Agents |
Dopamine Antagonists Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Therapeutic Uses Tranquilizing Agents |
ClinicalTrials.gov processed this record on March 03, 2015