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

NCT00511277 | Completed Phase 4

• 1 other identifier: D1449L00016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes in the Hamilton Depression Rating Scale (HAMDS) from Baseline to Endpoint

  treatment for six months

Secondary Outcomes (1)

• 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

Interventions

Seroquel® DRUG

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

Also known as: Quetiapine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Other Psychiatric disorders not in full remission, concomitant organic mental disorder or mental retardation
• Patients who, in the investigators judgement, pose an imminent risk of suicide or a danger to self or others
• Hamilton Depression Rating Scale\<7 points
• Female patients who are pregnant, lactating or at risk of pregnancy
• Female patients who are not using a highly effective method of birth control. A highly effective method of birth control is defined as those which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implantants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under investigation and its potential effect on the contraception must be addressed.
• history of idiopathic orthostatic hypotension, or condition that would predispose to (dehydration, hypovolaemia)
• Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B and C, via blood or other body fluids
• history of non-compliance as judged by the investigator
• Patients with substance dependence. A urine drug screen will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets the DSM-IV criteria for substance dependence
• Patients with known diabetes mellitus or impaired glucose tolerance, especially a patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
• unstable DM defined as enrollment glycosylated hemoglobin (HbA1c)\>8.5%
• patients admitted to hospital for treatment of DM or DM related illness in past 12 weeks
• patients not under physicians care for DM
• physicians responsible for patient´s DM care has not indicated that patient´s DM is controlled
• physician responsible for patient´s DM care has not approved patient´s participation in the study

Sponsors & Collaborators

• Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH: lead
• University of Göttingen: collaborator

Study Sites (1)

Department of Psychiatry and Psychotherapy, GEORG-AUGUST-UNIVERSITY GÖTTINGEN

Göttingen, Germany

Location

MeSH Terms

Conditions

Schizophrenia; Depression

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Peter Falkai, MD PhD

  Department of Psychiatry and Psychotherapy, GEORG-AUGUST-UNIVERSITY GÖTTINGEN, GERMANY

  STUDY DIRECTOR

• Thomas Wobrock, MD PhD

  Department of Psychiatry and Psychotherapy, GEORG-AUGUST-UNIVERSITY GÖTTINGEN, GERMANY

  PRINCIPAL INVESTIGATOR

• Andreas Heinz, MD PhD

  Department of Psychiatry and Psychotherapy, Charité Campus Mitte Berlin, Germany

  PRINCIPAL INVESTIGATOR

• Georg Juckel, MD PhD

  Department of Psychiatry, Ruhr University Bochum, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 3, 2007
• Study Start: August 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: April 1, 2011
• Last Updated: June 21, 2011

Record last verified: 2011-06

Locations

DE (1)