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Quetiapine in Postpartum Depression

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postpartum Depressive Disorder

Intervention: Quetiapine (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Luc Turmes, MD, Principal Investigator, Affiliation: Westfälisches Zentrum Herten, Psychiatrie und Psychotherapie Im Schlosspark 20 45699 Herten

Summary

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

Clinical Details

Official title: The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder With Psychotic Symptoms

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The Change in the Hamilton Rating Scale for Depression (HAM-D)

Secondary outcome:

Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS)

Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ)

Electrocardiogram (ECG), Vital Signs, Laboratory

Eligibility

Minimum age: 18 Years. Maximum age: 39 Years. Gender(s): Female.

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

Locations and Contacts

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

Starting date: August 2007
Last updated: December 7, 2010

Page last updated: August 23, 2015

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