Quetiapine in Postpartum Depression - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00681668

Purpose

The purpose of the study is to evaluate the efficacy and tolerability of quetiapine in female patients with postpartum depressive disorder with psychotic symptoms

Condition	Intervention	Phase
Postpartum Depressive Disorder	Drug: Quetiapine	Phase II

MedlinePlus related topics: Depression Postpartum Depression Psychotic Disorders

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder With Psychotic Symptoms

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in HAM-D [ Time Frame: 14 times during course of the study incl. baseline and final visit after 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in efficacy scales CGI, MADRS, BPRS [ Time Frame: 14 times during course of the study incl. baseline and final visit after 28 weeks ] [ Designated as safety issue: No ]
Change in functional outcome (GAF, PBQ) [ Time Frame: 14 times during course of the study incl. baseline and final visit after 28 weeks ] [ Designated as safety issue: No ]
Safety parameters (ECG, vital signs, laboratory [ Time Frame: up to 14 times during course of the study incl. baseline and final visit after 28 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	July 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Quetiapine 150-800mg	Drug: Quetiapine 150-800 mg, oral, bid

Eligibility

Ages Eligible for Study:	18 Years to 39 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of signed informed consent.
Female patients with severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points

Exclusion Criteria:

Woman with pre-existing psychotic disorder
Patients with alcohol or substance abuse or dependence
Patients who pose an imminent risk of suicide or danger to self or others

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681668

Locations

Germany, Westfalen-Lippe
Research Site
Herten, Westfalen-Lippe, Germany

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Luc Turmes, MD

Westfälisches Zentrum Herten, Psychiatrie und Psychotherapie Im Schlosspark 20 45699 Herten

More Information

Responsible Party:	AstraZeneca, MC Germany ( Kai Richter MD, Medical Director (comm), MC Germany )
Study ID Numbers:	D1449L00023
Study First Received:	May 20, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00681668
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

Postpartum Depression
Quetiapine
Psychotic Symptoms

Study placed in the following topic categories:

Quetiapine
Pregnancy Complications
Depression
Puerperal Disorders
Depression, Postpartum

Mental Disorders
Mood Disorders
Psychotic Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Tranquilizing Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009