Clinical Trial: Efficacy and Safety of Quetiapine in Treating Affective Symptoms of Patients With First-episode psychosis-a Pilot Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary: 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
Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Current Primary Outcome: Changes in the Hamilton Depression Rating Scale (HAMDS) from Baseline to Endpoint [ Time Frame: treatment for six months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in the Young Mania Rating Scale,Changes in the Positive and Negative Syndrome Scale,Changes in the Clinical Global Impression Scale(CGI,Changes in the self assessment of depressive symptoms(Beck Depression Inventory) from Baseline to Endpoint. [ Time Frame: for six months ]

Original Secondary Outcome: Same as current

Information By: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Dates:
Date Received: August 2, 2007
Date Started: August 2007
Date Completion:
Last Updated: June 20, 2011
Last Verified: June 2011