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Quetiapine in Postpartum Depression

NCT ID: NCT00681668

Last Updated: 2010-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-10-31

Brief Summary

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

Detailed Description

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Conditions

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Postpartum Depressive Disorder

Keywords

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Postpartum Depression Quetiapine Psychotic Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Quetiapine Fumarate 150 - 800mg

Quetiapine 150-800mg

Group Type EXPERIMENTAL

Quetiapine

Intervention Type DRUG

150-800 mg, oral, twice a day (bid)

Interventions

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Quetiapine

150-800 mg, oral, twice a day (bid)

Intervention Type DRUG

Other Intervention Names

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Seroquel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca, MC Germany

Principal Investigators

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Luc Turmes, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Research Site

Herten, Westfalen-Lippe, Germany

Site Status

Countries

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Germany

Other Identifiers

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D1449L00023

Identifier Type: -

Identifier Source: org_study_id