Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 24 of 455 for:    QUETIAPINE

Quetiapine in Postpartum Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 20, 2008
First Posted Date  ICMJE May 21, 2008
Results First Submitted Date  ICMJE October 29, 2009
Results First Posted Date  ICMJE September 17, 2010
Last Update Posted Date December 21, 2010
Study Start Date  ICMJE August 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
Change in HAM-D [ Time Frame: 14 times during course of the study incl. baseline and final visit after 28 weeks ]
Change History Complete list of historical versions of study NCT00681668 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quetiapine in Postpartum Depression
Official Title  ICMJE The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder With Psychotic Symptoms
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postpartum Depressive Disorder
Intervention  ICMJE Drug: Quetiapine
150-800 mg, oral, twice a day (bid)
Other Name: Seroquel
Study Arms  ICMJE Experimental: Quetiapine Fumarate 150 - 800mg
Quetiapine 150-800mg
Intervention: Drug: Quetiapine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 24, 2010)
5
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2008)
12
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00681668
Other Study ID Numbers  ICMJE D1449L00023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kai Richter MD, Medical Director (comm), MC Germany, AstraZeneca, MC Germany
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luc Turmes, MD Westfälisches Zentrum Herten, Psychiatrie und Psychotherapie Im Schlosspark 20 45699 Herten
PRS Account AstraZeneca
Verification Date December 2010

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