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TerminatedNCT00139074Updated Jan 28, 2013

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

A Phase 4 interventional study of Quetiapine fumarate and sodium valproate in Bipolar Disorder, sponsored by AstraZeneca. Terminated at 7 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-28.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Why this study was terminated
terminated due to very low recruitment rate (27 June 2006)
Phase
Phase 4
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bipolar Disorder

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Keywords

  • Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61)
03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 17 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients suffering from a manic or mixed episode.

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
17 participants (actual)

Study arms

  • Active comparator
    1

    quetiapine fumarate monotherapy

    Drug: Quetiapine fumarate

  • Experimental
    2

    Quetiapine + sodium valproate

    Drug: Quetiapine fumarate · Drug: sodium valproate

Interventions

  • DrugQuetiapine fumarate

    oral variable dose

    Also known as: Seroquel

  • Drugsodium valproate

    oral

06

What researchers measure

Primary outcomes

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

    Time frame: after 2 weeks treatment

07

Study locations

7 sites
  • Research Site
    Esbjerg, Denmark
  • Research Site
    Frederikssund, Denmark
  • Research Site
    Haderslev, Denmark
  • Research Site
    Hellerup, Denmark
  • Research Site
    Kobenhavn, Denmark
  • Research Site
    Kolding, Denmark
  • Researcg Site
    Svendborg, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00139074
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 31, 2005
Start date
Jul 2005
Primary completion
Jun 2006
Completion
Jun 2006
Last update
Jan 28, 2013

Study contacts

Dr. Rasmus Wenzer Licht
principal investigator · AstraZeneca
AstraZeneca Seroquel Medical Science Director, MD
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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