Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

• ClinicalTrials.gov Identifier: NCT00204061
• Recruitment Status: Completed
• First Posted: September 20, 2005
• Last Update Posted: December 24, 2014
• 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

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Schizophrenia; Psychoses	Behavioral: Supportive management; Drug: Amisulpride	Phase 4

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. improvement of risk related symptoms [ Time Frame: 3, 6, 12, 24 months ]
   Decrease of symptom scores; complete remission of risk related symptoms

Secondary Outcome Measures :

1. Global functioning [ Time Frame: 3, 6, 12, 24 months ]
   Increase of Global Assessment of Functioning (GAF) scores

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. 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

2. 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

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:

Click here for more information about this study: Early pharmacological and psychological intervention for late prodromal states of psychosis 

Homepage of co-ordinating center 

• 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
• Last Update Posted: December 24, 2014
• Last Verified: December 2014

Keywords provided by Stephan Ruhrmann, University of Cologne:

schizophrenia; psychosis; ultra high risk; prodromal state; early intervention; amisulpride

Additional relevant MeSH terms:

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