ClinicalTrials.gov
ClinicalTrials.gov Menu

Quetiapine in Postpartum Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Enrollment 5
Recruitment Details Study period July 2007 to October 2008; Medical Clinic - Westfälischen Zentrums Herten; Psychiatrie and Psychotherapie
Pre-assignment Details  
Arm/Group Title Quetiapine Fumarate 150 - 800mg
Hide Arm/Group Description Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
Period Title: Overall Study
Started 5
Completed 3
Not Completed 2
Reason Not Completed
Protocol Violation             1
Withdrawal by Subject             1
Arm/Group Title Quetiapine Fumarate 150 - 800mg
Hide Arm/Group Description Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants
18 to < 40 years 5
Between 18 and 65 years 0
>= 65 years 0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
5
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title The Change in the Hamilton Rating Scale for Depression (HAM-D)
Hide Description 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
Time Frame Baseline Day 1 to final visit 28 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumarate
Hide Arm/Group Description:
Quetiapine fumarate tablets
Overall Number of Participants Analyzed 5
Mean (Full Range)
Unit of Measure: scores on a HAM-D scale
21
(7 to 26)
2.Secondary Outcome
Title Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS)
Hide Description

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

Time Frame Baseline Day 1 to final visit 28 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed, study terminated
Arm/Group Title Quetiapine Fumarate
Hide Arm/Group Description:
Quetiapine fumarate tablets
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ)
Hide Description 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
Time Frame Baseline Day 1 to final visit 28 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed, study terminated
Arm/Group Title Quetiapine Fumarate
Hide Arm/Group Description:
Quetiapine fumarate tablets
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Electrocardiogram (ECG), Vital Signs, Laboratory
Hide Description

Safety parameter:s electrocardiogram (ECG), vital signs, laboratory

no participants analysed - terminated study

Time Frame Baseline Day 1 to final visit 28 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed, study terminated
Arm/Group Title Quetiapine Fumarate
Hide Arm/Group Description:
Quetiapine fumarate tablets
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine Fumarate 150 - 800mg
Hide Arm/Group Description Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
All-Cause Mortality
Quetiapine Fumarate 150 - 800mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine Fumarate 150 - 800mg
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine Fumarate 150 - 800mg
Affected / at Risk (%)
Total   3 
Gastrointestinal disorders   
Diarrhoea  1  1/5 (20.00%) 
Gastritis  1  1/5 (20.00%) 
Infections and infestations   
Nasopharyngitis  1  2/5 (40.00%) 
Skin and subcutaneous tissue disorders   
Eczema  1  1/5 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Study termination (the study could not finalised in the planned,nor in an acceptable time).
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.
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.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
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