Quetiapine in Postpartum Depression

NCT00681668 | Terminated Phase 2 Results

• 1 other identifier: D1449L00023
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Postpartum Depressive Disorder

Keywords

Postpartum Depression; Quetiapine; Psychotic Symptoms

Outcome Measures

Primary Outcomes (1)

• The Change in the Hamilton Rating Scale for Depression (HAM-D)

  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

  Baseline Day 1 to final visit 28 weeks

Secondary Outcomes (3)

• 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 Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ)

  Baseline Day 1 to final visit 28 weeks

• Electrocardiogram (ECG), Vital Signs, Laboratory

  Baseline Day 1 to final visit 28 weeks

Study Arms (1)

Quetiapine Fumarate 150 - 800mg

EXPERIMENTAL

Quetiapine 150-800mg

Drug: Quetiapine

Interventions

Quetiapine DRUG

150-800 mg, oral, twice a day (bid)

Also known as: Seroquel

Quetiapine Fumarate 150 - 800mg

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Herten, Westfalen-Lippe, Germany

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

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

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Luc Turmes, MD

  Westfälisches Zentrum Herten, Psychiatrie und Psychotherapie Im Schlosspark 20 45699 Herten

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 21, 2008
• Study Start: August 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 21, 2010
• Results First Posted: September 17, 2010

Record last verified: 2010-12

Locations

DE (1)