Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00204061|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Psychoses||Behavioral: Supportive management Drug: Amisulpride||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2005|
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
24 months amisulpride 50 to 800 mg, needs-focused, unspecific supportive management.
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
- improvement of risk related symptoms [ Time Frame: 3, 6, 12, 24 months ]Decrease of symptom scores; complete remission of risk related symptoms
- Global functioning [ Time Frame: 3, 6, 12, 24 months ]Increase of Global Assessment of Functioning (GAF) scores
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204061
|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|