search
Back to results

Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder (UNIQUE)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Quetiapine fumarate (Seroquel)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring considered, entry, into, the study, SSRI, Seroquel, Quetiapine, fumarate, antipsychotic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site

Outcomes

Primary Outcome Measures

The Montgomery-Asberg Depression Scale (MADRS) score

Secondary Outcome Measures

The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs)
Sheehan Disability Scale (SDS) score
The Symptom Checklist 90 Revisred (SCL-90-R) score

Full Information

First Posted
August 12, 2008
Last Updated
March 24, 2009
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00733668
Brief Title
Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder
Acronym
UNIQUE
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
considered, entry, into, the study, SSRI, Seroquel, Quetiapine, fumarate, antipsychotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate (Seroquel)
Other Intervention Name(s)
Seroquel
Intervention Description
300 mg, PO, 100 mg morning, 200 mg evening, 4 weeks
Primary Outcome Measure Information:
Title
The Montgomery-Asberg Depression Scale (MADRS) score
Time Frame
Visit 1 - > 5
Secondary Outcome Measure Information:
Title
The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs)
Time Frame
Visit 1 - > 5 (1 week between each visit)
Title
Sheehan Disability Scale (SDS) score
Time Frame
Visit 1 - > 5 (1 week between each visit)
Title
The Symptom Checklist 90 Revisred (SCL-90-R) score
Time Frame
Visit 1 - > 5 (1 week between each visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inform consent Male and female, age between 18 and 65 years. Naïve to any atypical antipsychotic A diagnosis of major depressive disorder Exclusion Criteria: No use of fluvoxamine Patients with a history of bipolar I or II disorder Diagnosis of psychotic major depression disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pr. Demyttenaere
Organizational Affiliation
KUL
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Brugge
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Liege
Country
Belgium
Facility Name
Research Site
City
Sint-Truiden
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder

We'll reach out to this number within 24 hrs