Overview

Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients

Status:
Completed
Trial end date:
2016-06-22
Target enrollment:
0
Participant gender:
All
Summary
The main objective of the trial is to evaluate, how long an antipsychotic relapse-prevention should be continued and to which time a patient with schizophrenia is protected enough, so that a withdrawal or reduction of the medication seems appropriate. Relapse is defined as primary outcome.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Technische Universität München
Treatments:
Amisulpride
Antipsychotic Agents
Benperidol
Bromperidol
Clopenthixol
Fluphenazine
Fluphenazine depot
Fluphenazine enanthate
Fluspirilene
Haloperidol
Olanzapine
Paliperidone Palmitate
Perazine
Perphenazine
Pimozide
Quetiapine Fumarate
Risperidone
Sertindole
Sulpiride
Sultopride
Thioridazine
Ziprasidone
Criteria
Inclusion Criteria:

- 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, 1976)

- 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