Quetiapine in Postpartum Depression
December 7, 2010 updated by: AstraZeneca
The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder With Psychotic Symptoms
The purpose of the study is to evaluate the efficacy and tolerability of quetiapine in female patients with postpartum depressive disorder with psychotic symptoms
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Westfalen-Lippe
-
Herten, Westfalen-Lippe, Germany
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Quetiapine Fumarate 150 - 800mg
Quetiapine 150-800mg
|
150-800 mg, oral, twice a day (bid)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Change in the Hamilton Rating Scale for Depression (HAM-D)
Time Frame: Baseline Day 1 to final visit 28 weeks
|
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
|
Baseline Day 1 to final visit 28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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 |
Baseline Day 1 to final visit 28 weeks
|
|
Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ)
Time Frame: Baseline Day 1 to final visit 28 weeks
|
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
|
Baseline Day 1 to final visit 28 weeks
|
|
Electrocardiogram (ECG), Vital Signs, Laboratory
Time Frame: Baseline Day 1 to final visit 28 weeks
|
Safety parameter:s electrocardiogram (ECG), vital signs, laboratory no participants analysed - terminated study |
Baseline Day 1 to final visit 28 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Luc Turmes, MD, Westfälisches Zentrum Herten, Psychiatrie und Psychotherapie Im Schlosspark 20 45699 Herten
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (ACTUAL)
October 1, 2008
Study Completion (ACTUAL)
October 1, 2008
Study Registration Dates
First Submitted
May 20, 2008
First Submitted That Met QC Criteria
May 20, 2008
First Posted (ESTIMATE)
May 21, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
December 21, 2010
Last Update Submitted That Met QC Criteria
December 7, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1449L00023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.