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Quetiapine in Postpartum Depression

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ClinicalTrials.gov Identifier: NCT00681668
Recruitment Status : Terminated (Recruitment behind plan, no increase expected)
First Posted : May 21, 2008
Results First Posted : September 17, 2010
Last Update Posted : December 21, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Postpartum Depressive Disorder
Intervention: Drug: Quetiapine

  Participant Flow

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

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.
No text entered.

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

Baseline Measures
   Quetiapine Fumarate 150 - 800mg 
Overall Participants Analyzed 
[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

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

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 ]

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 ]

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


  Serious Adverse Events


  Other Adverse Events


  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).


  More Information

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:
unchecked 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.
unchecked 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.


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



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
First Submitted: May 20, 2008
First Posted: May 21, 2008
Results First Submitted: October 29, 2009
Results First Posted: September 17, 2010
Last Update Posted: December 21, 2010