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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
Information provided by:

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

Condition or disease Intervention/treatment Phase
Postpartum Depressive Disorder Drug: Quetiapine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder With Psychotic Symptoms
Study Start Date : August 2007
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Quetiapine Fumarate 150 - 800mg
Quetiapine 150-800mg
Drug: Quetiapine
150-800 mg, oral, twice a day (bid)
Other Name: Seroquel

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681668

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

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 Posted: May 21, 2008    Key Record Dates
Results First Posted: September 17, 2010
Last Update Posted: December 21, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Postpartum Depression
Psychotic Symptoms

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