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Clinical Trials/DRKS00006878
DRKS00006878
Not yet recruiting
Phase 4

Evaluation of the necessity of long-term pharmacological treatment withantipsychotics for the prevention of relapse in long-term stabilizedschizophrenic patients: a randomized, single-blind, longitudinal trial

Klinikum rechts der Isar der TU München0 sites25 target enrollmentNovember 6, 2014
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ConditionsF20F25SchizophreniaSchizoaffective disorders

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
F20
Sponsor
Klinikum rechts der Isar der TU München
Enrollment
25
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 6, 2014
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Klinikum rechts der Isar der TU München

Eligibility Criteria

Inclusion Criteria

  • •Male or female patients, 18 to 65 years of age.
  • •\- Diagnosis of schizophrenia or schizoaffective disorder.
  • •\- The participants have to be in remission for at least 3 years (i.e. no psychiatric
  • •hospitalisation) under a stable antipsychotic medication. Remission will be measured using the remission criteria by Andreasen et al. (2005\)
  • •Score \=3 for the items concerning psychosis of the Positive and Negative Syndrom Scale (PANSS; Kay et al., 1987\):
  • •Delusions (P1\), Conceptual disorganisation (P2\), Halluzinations (P3\), Mannerisms and posturing (G5\) and Unusual thought content (G9\) and a score \=3 on the Clinical Global Impression Severity Scale (CGI\-S; Guy, 1976b)
  • •\- Able to give informed consent.

Exclusion Criteria

  • •\- Actively suicidal.
  • •\- Serious medical illnesses.
  • •\- Known non\-complience concerning the medication.
  • •\- Medication with clozapin.
  • •\- Medication with antidepressants and mood stabilisors that were initiated during the last 6 weeks before study enrollment.
  • •\- Patients with substance dependence other than nicotine or caffeine within 6 months prior to baseline.
  • •\- Unability to give informed consent.
  • •\- Pregnancy.

Outcomes

Primary Outcomes

Not specified

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