NCT00733668

Brief Summary

An open-label, non-comparative, multi-centre, phase II prospective trial to assess the efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors (SSRIs) in SSRI-resistant major depressive disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

1.7 years

First QC Date

August 12, 2008

Last Update Submit

March 24, 2009

Conditions

Major Depressive Disorder

Keywords

consideredentryintothe studySSRISeroquelQuetiapinefumarateantipsychotic

Outcome Measures

Primary Outcomes (1)

  • The Montgomery-Asberg Depression Scale (MADRS) score

    Visit 1 - > 5

Secondary Outcomes (3)

  • The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs)

    Visit 1 - > 5 (1 week between each visit)

  • Sheehan Disability Scale (SDS) score

    Visit 1 - > 5 (1 week between each visit)

  • The Symptom Checklist 90 Revisred (SCL-90-R) score

    Visit 1 - > 5 (1 week between each visit)

Interventions

Quetiapine fumarate (Seroquel)DRUG

300 mg, PO, 100 mg morning, 200 mg evening, 4 weeks

Also known as: Seroquel

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inform consent
  • Male and female, age between 18 and 65 years.
  • Naïve to any atypical antipsychotic
  • A diagnosis of major depressive disorder

You may not qualify if:

  • No use of fluvoxamine
  • Patients with a history of bipolar I or II disorder
  • Diagnosis of psychotic major depression disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Bruges, Belgium

Location

Research Site

Leuven, Belgium

Location

Research Site

Liège, Belgium

Location

Research Site

Sint-Truiden, Belgium

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pr. Demyttenaere

    KUL

    STUDY DIRECTOR

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

August 12, 2008

First Posted

August 13, 2008

Study Start

March 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

BE(4)