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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
Sponsor:
Information provided by:
AstraZeneca

May 20, 2008
May 21, 2008
October 29, 2009
September 17, 2010
December 21, 2010
August 2007
October 2008   (Final data collection date for primary outcome measure)
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
Change in HAM-D [ Time Frame: 14 times during course of the study incl. baseline and final visit after 28 weeks ]
Complete list of historical versions of study NCT00681668 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
  • Change in efficacy scales CGI, MADRS, BPRS [ Time Frame: 14 times during course of the study incl. baseline and final visit after 28 weeks ]
  • Change in functional outcome (GAF, PBQ) [ Time Frame: 14 times during course of the study incl. baseline and final visit after 28 weeks ]
  • Safety parameters (ECG, vital signs, laboratory [ Time Frame: up to 14 times during course of the study incl. baseline and final visit after 28 weeks ]
Not Provided
Not Provided
 
Quetiapine in Postpartum Depression
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
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Postpartum Depressive Disorder
Drug: Quetiapine
150-800 mg, oral, twice a day (bid)
Other Name: Seroquel
Experimental: Quetiapine Fumarate 150 - 800mg
Quetiapine 150-800mg
Intervention: Drug: Quetiapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
12
October 2008
October 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 39 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00681668
D1449L00023
No
Not Provided
Not Provided
Kai Richter MD, Medical Director (comm), MC Germany, AstraZeneca, MC Germany
AstraZeneca
Not Provided
Principal Investigator: Luc Turmes, MD Westfälisches Zentrum Herten, Psychiatrie und Psychotherapie Im Schlosspark 20 45699 Herten
AstraZeneca
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP