Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157378
Status:
UNKNOWN
Last Update Posted:
2005-09-12
First Post:
2005-09-08
Brief Title:
Optimization of Acute Treatment in First Episode Schizophrenia
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
Optimization of Acute Treatment in First Episode Schizophrenic Patients by New Pharmacological Treatments
Status:
UNKNOWN
Status Verified Date:
2000-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a multicenter double-blind randomized parallel-group study with first episode schizophrenic patients During a treatment phase of 8 weeks the patients are treated with Risperidone or Haloperidol Aim of the project is to compare the effects of the atypical neuroleptic Risperidone with those of the conventional neuroleptic Haloperidol and to evaluate whether the assumed advantages of atypical neuroleptics compared to conventional neuroleptics are also present when both medications are administered in rather low daily dosages min 2 mgd max 8 mgd
Detailed Description:
Considering that first episode schizophrenic patients compared to multiple episode patients respond to lower dosages of neuroleptics the study aims to reach neuroleptic response under the lowest possible dosage of the study medication haloperidol or risperidone Therefore the initial dosage of the study medication is 2 mgd Depending on the patients symptomatology the daily dosage of the study medication can be increased by 2 mg in weekly intervals up to a maximum dosage of 8 mgd Patients with the diagnosis of schizophrenia F20 according to ICD-10-criteria are consecutively enrolled in the study The patients are assessed at weekly intervals during the acute inpatient treatment phase of 8 weeks Apart from the weekly psychopathological characterisation additionally neuropsychobiological data are assessed at the time of admission and at the end of the study Major questions of the study are whether patients who have been treated with risperidone compared with those who have been treated with haloperidol show a better treatment outcome regarding negative symptoms and exhibit fewer extra-pyramidal motor side effects Furthermore it is hypothesised that the treatment with Risperidone has better effects on cognitive disordersdysfunctions and depressive symptoms and that the patients who receive Risperidone are more compliant and have a higher quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None