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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| German Research Network On Schizophrenia | NETWORK |
| Sanofi-Synthelabo | INDUSTRY |
| Department of Psychiatry University of Bonn |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| supportive management | Placebo Comparator | needs-focused, unspecific supportive management |
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| amisulpride | Experimental | 24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supportive management | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| improvement of risk related symptoms | Decrease of symptom scores; complete remission of risk related symptoms | 3, 6, 12, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Global functioning | Increase of Global Assessment of Functioning (GAF) scores | 3, 6, 12, 24 months |
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Inclusion Criteria:
General criteria
Special criteria (present within the last three months prior to the study)
AND / OR
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Klosterkötter, Professor | Department of Psychiatry and Psycotherapy University of Cologne | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psycotherapy University of Cologne | Cologne | North Rhine-Westphalia | 50924 | Germany |
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| Label | URL |
|---|---|
| Click here for more information about this study: Early pharmacological and psychological intervention for late prodromal states of psychosis | View source |
| Homepage of co-ordinating center | View source |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D062706 | Prodromal Symptoms |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077582 | Amisulpride |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| OTHER |
| Heinrich-Heine University, Duesseldorf | OTHER |
| Ludwig-Maximilians - University of Munich | OTHER |
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| Amisulpride | Drug | 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. |
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| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |