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Quetiapine in Postpartum Depression

Primary Purpose

Postpartum Depressive Disorder

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Quetiapine
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depressive Disorder focused on measuring Postpartum Depression, Quetiapine, Psychotic Symptoms

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Quetiapine Fumarate 150 - 800mg

Arm Description

Quetiapine 150-800mg

Outcomes

Primary Outcome Measures

The Change in the Hamilton Rating Scale for Depression (HAM-D)
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

Secondary Outcome Measures

Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS)
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)
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
Safety parameter:s electrocardiogram (ECG), vital signs, laboratory no participants analysed - terminated study

Full Information

First Posted
May 20, 2008
Last Updated
December 7, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00681668
Brief Title
Quetiapine in Postpartum Depression
Official Title
The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder With Psychotic Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Terminated
Why Stopped
Recruitment behind plan, no increase expected
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depressive Disorder
Keywords
Postpartum Depression, Quetiapine, Psychotic Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetiapine Fumarate 150 - 800mg
Arm Type
Experimental
Arm Description
Quetiapine 150-800mg
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
Seroquel
Intervention Description
150-800 mg, oral, twice a day (bid)
Primary Outcome Measure Information:
Title
The Change in the Hamilton Rating Scale for Depression (HAM-D)
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
Secondary Outcome Measure Information:
Title
Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS)
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
Title
Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ)
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
Title
Electrocardiogram (ECG), Vital Signs, Laboratory
Description
Safety parameter:s electrocardiogram (ECG), vital signs, laboratory no participants analysed - terminated study
Time Frame
Baseline Day 1 to final visit 28 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Turmes, MD
Organizational Affiliation
Westfälisches Zentrum Herten, Psychiatrie und Psychotherapie Im Schlosspark 20 45699 Herten
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Herten
State/Province
Westfalen-Lippe
Country
Germany

12. IPD Sharing Statement

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Quetiapine in Postpartum Depression

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