Quetiapine in Postpartum Depression

Phase 2

Terminated

• Conditions: Postpartum Depressive Disorder
• Interventions: Drug: Quetiapine

• Registration Number: NCT00681668
• Lead Sponsor: AstraZeneca

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 available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-05-20
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-10-29
• Results First Submitted QC: 2010-08-24
• Results First Posted: 2010-09-17
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Quetiapine Fumarate 150 - 800mg	Quetiapine	Quetiapine 150-800mg

Primary Outcome Measures

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

Name	Time	Method
Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS)	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)	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	Baseline Day 1 to final visit 28 weeks	Safety parameter:s electrocardiogram (ECG), vital signs, laboratory; no participants analysed - terminated study

Trial Locations

Locations (1)

Research Site; 🇩🇪 Herten, Westfalen-Lippe, Germany