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

Results First Received: October 29, 2009

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Postpartum Depressive Disorder
Intervention:	Drug: Quetiapine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study period July 2007 to October 2008; Medical Clinic - Westfälischen Zentrums Herten; Psychiatrie and Psychotherapie

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Quetiapine Fumarate 150 - 800mg	Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks

Participant Flow: Overall Study

	Quetiapine Fumarate 150 - 800mg
STARTED	5
COMPLETED	3
NOT COMPLETED	2
Protocol Violation	1
Withdrawal by Subject	1

Baseline Characteristics

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Reporting Groups

	Description
Quetiapine Fumarate 150 - 800mg	Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks

Baseline Measures

	Quetiapine Fumarate 150 - 800mg
Number of Participants [units: participants]	5
Age, Customized [units: Participants]
18 to < 40 years	5
Between 18 and 65 years	0
>= 65 years	0
Gender [units: Participants]
Female	5
Male	0

Outcome Measures

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1. Primary:

The Change in the Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Baseline Day 1 to final visit 28 weeks ]

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2. Secondary:

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 ]

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3. Secondary:

Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ) [ Time Frame: Baseline Day 1 to final visit 28 weeks ]

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4. Secondary:

Electrocardiogram (ECG), Vital Signs, Laboratory [ Time Frame: Baseline Day 1 to final visit 28 weeks ]

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Measure Type	Secondary
Measure Title	Electrocardiogram (ECG), Vital Signs, Laboratory
Measure Description	Safety parameter:s electrocardiogram (ECG), vital signs, laboratory no participants analysed - terminated study
Time Frame	Baseline Day 1 to final visit 28 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data not analyzed, study terminated

Reporting Groups

	Description
Quetiapine Fumarate	Quetiapine fumarate tablets

Measured Values

	Quetiapine Fumarate
Number of Participants Analyzed [units: participants]	0
Electrocardiogram (ECG), Vital Signs, Laboratory [units: participants]

No statistical analysis provided for Electrocardiogram (ECG), Vital Signs, Laboratory

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Site has to inform sponsor about a publication at least 60 day in advance and 10 days before submission of an abstract or presenation. Change requests by the sponsor are recognized unless the scientific character or the objectivity is on risk. If the sponsor plans a patent applicaion the publication has to be postponed up to 120 days.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study termination (the study could not finalised in the planned,nor in an acceptable time).

Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

Responsible Party:	Kai Richter MD, Medical Director (comm), MC Germany, AstraZeneca, MC Germany
ClinicalTrials.gov Identifier:	NCT00681668 History of Changes
Other Study ID Numbers:	D1449L00023
Study First Received:	May 20, 2008
Results First Received:	October 29, 2009
Last Updated:	December 7, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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