NCT00139074

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

7 active sites

Status
terminated

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

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

11 months

First QC Date

August 29, 2005

Last Update Submit

January 25, 2013

Conditions

Bipolar Disorder

Keywords

Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61)

Outcome Measures

Primary Outcomes (1)

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

    after 2 weeks treatment

Study Arms (2)

1

ACTIVE COMPARATOR

quetiapine fumarate monotherapy

Drug: Quetiapine fumarate

2

EXPERIMENTAL

Quetiapine + sodium valproate

Drug: Quetiapine fumarateDrug: sodium valproate

Interventions

Quetiapine fumarateDRUG

oral variable dose

Also known as: Seroquel
12
sodium valproateDRUG

oral

2

Eligibility Criteria

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

You may qualify if:

  • Patients suffering from a manic or mixed episode.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research Site

Copenhagen, Denmark

Location

Research Site

Esbjerg, Denmark

Location

Research Site

Frederikssund, Denmark

Location

Research Site

Haderslev, Denmark

Location

Research Site

Hellerup, Denmark

Location

Research Site

Kolding, Denmark

Location

Researcg Site

Svendborg, Denmark

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Quetiapine FumarateValproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Dr. Rasmus Wenzer Licht

    AstraZeneca

    PRINCIPAL INVESTIGATOR

  • AstraZeneca Seroquel Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

July 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

DK(7)