Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
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ClinicalTrials.gov Identifier: NCT00204061 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Last Update Posted : December 24, 2014
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Condition or disease | Intervention/treatment | Phase |
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Schizophrenia Psychoses | Behavioral: Supportive management Drug: Amisulpride | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 124 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: supportive management
needs-focused, unspecific supportive management
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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.
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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 |
- 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

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Ages Eligible for Study: | 14 Years to 36 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
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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).

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
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 |
Responsible Party: | Stephan Ruhrmann, Deputy Head of the Department of Psychiatry, University of Cologne |
ClinicalTrials.gov Identifier: | NCT00204061 |
Other Study ID Numbers: |
01 GI 9935 - P 1.1.3 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | December 24, 2014 |
Last Verified: | December 2014 |
schizophrenia psychosis ultra high risk |
prodromal state early intervention amisulpride |
Prodromal Symptoms Schizophrenia Psychotic Disorders Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders Amisulpride Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents |