Quetiapine in Postpartum Depression

This study has been terminated.

(Recruitment behind plan, no increase expected)

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00681668

First received: May 20, 2008

Last updated: December 7, 2010

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

May 20, 2008

Last Updated Date

December 7, 2010

Start Date ^ICMJE

August 2007

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The Change in the Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Baseline Day 1 to final visit 28 weeks ] [ Designated as safety issue: No ]

HAM-D is a 17-21 item observer-rated scale to assess presence and severity of depressive states. 9 items are scored 0-4, whereas the further 8 are scored 0-2, as these represent variables which do not lend themselves to quantitative rating (0=absent; 1=doubtful or slislight; 2=clearly present). Higher scores indicate higer depressive state

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00681668 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Baseline Day 1 to final visit 28 weeks ] [ Designated as safety issue: No ]
Change in efficacy scales: Clinical Global Impression (CGI),Scale of 1-7 (1 = normal or no change - 7 = extremely ill or extreme changes).

Montgomery Asberg Depression Rating scale (MADRS) 10 questions with a scale of 1-4 (1 = no symptoms - 4 = severe symptoms), higher score = worst values.

Brief Psychiatric rating scale (BPRS)- 24 symptom constructs, each to be rated in a 7-point scale of severity ranging from 'not present' to 'extremely severe' no participants analysed - terminated study
Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ) [ Time Frame: Baseline Day 1 to final visit 28 weeks ] [ Designated as safety issue: No ]
Change in functional outcome: Global Assessment of Functioning (GAF),scale of 1-100 (1 = severe symptoms - 100 = no symptoms) Parental bonding Questionnaire (PBQ) no participants analysed - terminated study
Electrocardiogram (ECG), Vital Signs, Laboratory [ Time Frame: Baseline Day 1 to final visit 28 weeks ] [ Designated as safety issue: No ]
Safety parameter:s electrocardiogram (ECG), vital signs, laboratory

no participants analysed - terminated study

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Quetiapine in Postpartum Depression

Official Title ^ICMJE

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

Brief 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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Postpartum Depressive Disorder

Intervention ^ICMJE

Drug: Quetiapine

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

Other Name: Seroquel

Study Arm (s)

Experimental: Quetiapine Fumarate 150 - 800mg

Quetiapine 150-800mg

Intervention: Drug: Quetiapine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 39 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00681668

Other Study ID Numbers ^ICMJE

D1449L00023

Has Data Monitoring Committee

Responsible Party

Kai Richter MD, Medical Director (comm), MC Germany, AstraZeneca, MC Germany

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Luc Turmes, MD

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

Information Provided By

AstraZeneca

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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