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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00511277

Enrollment

Registered

2007-08-03

Start date

2007-08-31

Completion date

2011-04-30

Last updated

2011-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

quetiapine, schizophrenia, first-episode psychosis, depression, psychopathology

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 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

Interventions

DRUGSeroquel®

dosage form: oral, dosage: 300-800mg/d, frequency: twice daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

All patients who meet the following inclusion criteria are eligible to participate in the study: * male and female patients with first-episode schizophrenia (based on ICD-10 criteria) * in- and out-patients * age between 18 and 45 * verbal IQ 85 * given written informed consent

Exclusion criteria

Patients who meet one or more of the following

Design outcomes

Primary

Measure	Time frame
Changes in the Hamilton Depression Rating Scale (HAMDS) from Baseline to Endpoint	treatment for six months

Secondary

Measure	Time frame
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.	for six months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026