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Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients

Primary Purpose

Bipolar Disorder

Status
Terminated
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Quetiapine fumarate
sodium valproate
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61)

Eligibility Criteria

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

Inclusion Criteria: Patients suffering from a manic or mixed episode. Exclusion Criteria: Patients who have not provided personal informed consent, Known intolerance, hypersensitivity or lack of antimanic response to sodium valproate or quetiapine fumarate, Involuntary admittance/detainment.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Researcg Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

quetiapine fumarate monotherapy

Quetiapine + sodium valproate

Outcomes

Primary Outcome Measures

The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate)

Secondary Outcome Measures

Full Information

First Posted
August 29, 2005
Last Updated
January 25, 2013
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00139074
Brief Title
Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients
Official Title
Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
terminated due to very low recruitment rate (27 June 2006)
Study Start Date
July 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14 days in non-responding patients after a 14 day initial treatment period with quetiapine. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
quetiapine fumarate monotherapy
Arm Title
2
Arm Type
Experimental
Arm Description
Quetiapine + sodium valproate
Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate
Other Intervention Name(s)
Seroquel
Intervention Description
oral variable dose
Intervention Type
Drug
Intervention Name(s)
sodium valproate
Intervention Description
oral
Primary Outcome Measure Information:
Title
The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate)
Time Frame
after 2 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suffering from a manic or mixed episode. Exclusion Criteria: Patients who have not provided personal informed consent, Known intolerance, hypersensitivity or lack of antimanic response to sodium valproate or quetiapine fumarate, Involuntary admittance/detainment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Rasmus Wenzer Licht
Organizational Affiliation
AstraZeneca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
AstraZeneca Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Esbjerg
Country
Denmark
Facility Name
Research Site
City
Frederikssund
Country
Denmark
Facility Name
Research Site
City
Haderslev
Country
Denmark
Facility Name
Research Site
City
Hellerup
Country
Denmark
Facility Name
Research Site
City
Kobenhavn
Country
Denmark
Facility Name
Research Site
City
Kolding
Country
Denmark
Facility Name
Researcg Site
City
Svendborg
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients

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