Trial Outcomes & Findings for Quetiapine in Postpartum Depression (NCT NCT00681668)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Baseline Day 1 to final visit 28 weeks

Results posted on

2010-12-21

Participant Flow

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

Participant milestones

Participant milestones
Measure	Quetiapine Fumarate 150 - 800mg Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Quetiapine Fumarate 150 - 800mg Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Quetiapine in Postpartum Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quetiapine Fumarate 150 - 800mg n=5 Participants Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
Age, Customized 18 to < 40 years	5 Participants n=5 Participants
Age, Customized Between 18 and 65 years	0 Participants n=5 Participants
Age, Customized >= 65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Quetiapine Fumarate n=5 Participants Quetiapine fumarate tablets
The Change in the Hamilton Rating Scale for Depression (HAM-D)	21 scores on a HAM-D scale Interval 7.0 to 26.0

SECONDARY outcome

Timeframe: Baseline Day 1 to final visit 28 weeks

Population: Data not analyzed, study terminated

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline Day 1 to final visit 28 weeks

Population: Data not analyzed, study terminated

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline Day 1 to final visit 28 weeks

Population: Data not analyzed, study terminated

Safety parameter:s electrocardiogram (ECG), vital signs, laboratory no participants analysed - terminated study

Outcome measures

Outcome data not reported

Adverse Events

Quetiapine Fumarate 150 - 800mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Quetiapine Fumarate 150 - 800mg n=5 participants at risk Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks
Infections and infestations Nasopharyngitis	40.0% 2/5
Gastrointestinal disorders Diarrhoea	20.0% 1/5
Skin and subcutaneous tissue disorders Eczema	20.0% 1/5
Gastrointestinal disorders Gastritis	20.0% 1/5

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER