Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511277
Status:
COMPLETED
Last Update Posted:
2011-06-21
First Post:
2007-08-02
Brief Title:
Efficacy and Safety of Quetiapine in Treating Affective Symptoms of Patients With First-episode psychosis-a Pilot Study
Sponsor:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Organization:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Study Overview
Official Title:
Single-arm Open-label and Multicenter Phase IV Study Efficacy and Safety of Quetiapine in Treating Affective Symptoms of Patients With First-episode Psychosis - a Pilot Study
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
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 purpose of this study is
To investigate whether a treatment with quetiapine for six months in patients with first-episode psychosis may be effective in treating depressive symptoms
To investigate whether a treatment with quetiapine for six months in patients with first-episode psychosis may be effective in mania-like symptoms and to evaluate the general efficacy in psychopathology as well as the safety and tolerability of quetiapine
To investigate whether a treatment with quetiapine for six months in patients with first-episode psychosis may be effective in treating depressive symptoms
To investigate whether a treatment with quetiapine for six months in patients with first-episode psychosis may be effective in mania-like symptoms and to evaluate the general efficacy in psychopathology as well as the safety and tolerability of quetiapine
Detailed Description:
Affective symptoms in particular depressive symptoms are prevalent in up to 60 of all patients with schizophrenia However it is still uncertain whether depressive symptoms have a prognostic value having previously been associated with both favorable and poor outcome In addition treatment of affective symptoms in patients with schizophrenia is difficult There is some evidence that atypical antipsychotics such as quetiapine may contribute not only to a reduction in psychotic symptoms but also that these agents may produce an antidepressant effect in schizophrenia and may reduce suicidality Most of these studies suffer from methodological limitations as the efficacy on affective symptoms has not been the primary target parameter Concerning the prevalence of affective symptoms in first-episode psychosis knowledge is still poor This is why we have developed a study design for a pilot-study on 60 patients with first-episode schizophrenia aiming to demonstrate that a treatment with quetiapine over the period of 6 months shows clinical efficacy on affective particularly depressive symptoms
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