Quetiapine in Postpartum Depression

• Sponsor: AstraZeneca (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00681668
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Months): 14
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• 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: Aug 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00681668
• Other Study ID Numbers: D1449L00023
• First Posted: May 21, 2008
• Last Update Posted: Dec 21, 2010
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: Postpartum Depression; Quetiapine; Psychotic Symptoms
• Additional relevant MeSH terms: Depressive Disorder; Depression; Quetiapine Fumarate

Study Results

Participant Flow

Recruitment Details	Study period July 2007 to October 2008; Medical Clinic - Westfälischen Zentrums Herten; Psychiatrie and Psychotherapie

Arm/Group Title	Quetiapine Fumarate 150 - 800mg
Arm/Group Description	Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
Period Title: Overall Study
STARTED	5
COMPLETED	3
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Quetiapine Fumarate 150 - 800mg
Arm/Group Description	Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
Overall Participants	5
Age, Customized (Number) [Number]
18 to < 40 years	5 100%
Between 18 and 65 years	0 0%
>= 65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	5 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	The Change in the Hamilton Rating Scale for Depression (HAM-D)
Description	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
Time Frame	Baseline Day 1 to final visit 28 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Quetiapine Fumarate
Arm/Group Description	Quetiapine fumarate tablets
Measure Participants	5
Mean (Full Range) [scores on a HAM-D scale]	21

2. Secondary Outcome

Title	Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS)
Description	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
Time Frame	Baseline Day 1 to final visit 28 weeks

Outcome Measure Data

Analysis Population Description

Data not analyzed, study terminated

Arm/Group Title	Quetiapine Fumarate
Arm/Group Description	Quetiapine fumarate tablets
Measure Participants	0

3. Secondary Outcome

Title	Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ)
Description	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
Time Frame	Baseline Day 1 to final visit 28 weeks

Outcome Measure Data

Analysis Population Description

Data not analyzed, study terminated

Arm/Group Title	Quetiapine Fumarate
Arm/Group Description	Quetiapine fumarate tablets
Measure Participants	0

4. Secondary Outcome

Title	Electrocardiogram (ECG), Vital Signs, Laboratory
Description	Safety parameter:s electrocardiogram (ECG), vital signs, laboratory no participants analysed - terminated study
Time Frame	Baseline Day 1 to final visit 28 weeks

Outcome Measure Data

Analysis Population Description

Data not analyzed, study terminated

Arm/Group Title	Quetiapine Fumarate
Arm/Group Description	Quetiapine fumarate tablets
Measure Participants	0

Adverse Events

Arm/Group Title	Quetiapine Fumarate 150 - 800mg
Arm/Group Description	Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
All Cause Mortality
	Quetiapine Fumarate 150 - 800mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Quetiapine Fumarate 150 - 800mg
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Quetiapine Fumarate 150 - 800mg
	Affected / at Risk (%)	# Events
Total	3/ (NaN)
Gastrointestinal disorders
Diarrhoea	1/5 (20%)
Gastritis	1/5 (20%)
Infections and infestations
Nasopharyngitis	2/5 (40%)
Skin and subcutaneous tissue disorders
Eczema	1/5 (20%)

Limitations/Caveats

Study termination (the study could not finalised in the planned,nor in an acceptable time).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Site has to inform sponsor about a publication at least 60 day in advance and 10 days before submission of an abstract or presenation. Change requests by the sponsor are recognized unless the scientific character or the objectivity is on risk. If the sponsor plans a patent applicaion the publication has to be postponed up to 120 days.