NCT00511277

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Seroquel®	dosage form: oral, dosage: 300-800mg/d, frequency: twice daily

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-10-01
• Completion: 2011-04-01
• First posted: 2007-08-03
• Last updated: 2011-06-21

Locations

1 site across 1 country: Germany