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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
  Purpose

The purpose of the study is to evaluate the efficacy and tolerability of quetiapine in female patients with postpartum depressive disorder with psychotic symptoms


Condition Intervention Phase
Postpartum Depressive Disorder
 Drug: Quetiapine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder With Psychotic Symptoms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The Change in the Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Baseline Day 1 to final visit 28 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline Day 1 to final visit 28 weeks ] [ Designated as safety issue: No ]

    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) [ Time Frame: Baseline Day 1 to final visit 28 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline Day 1 to final visit 28 weeks ] [ Designated as safety issue: No ]

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

    no participants analysed - terminated study



Enrollment: 5
Study Start Date: August 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quetiapine Fumarate 150 - 800mg
Quetiapine 150-800mg
 Drug: Quetiapine
150-800 mg, oral, twice a day (bid)
Other Name: Seroquel

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681668

Locations
Germany
Research Site
Herten, Westfalen-Lippe, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Luc Turmes, MD Westfälisches Zentrum Herten, Psychiatrie und Psychotherapie Im Schlosspark 20 45699 Herten
  More Information

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

Keywords provided by AstraZeneca:
Postpartum Depression
Quetiapine
Psychotic Symptoms

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Quetiapine
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013