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Trial record 71 of 450 for:    QUETIAPINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00139074
Recruitment Status : Terminated (terminated due to very low recruitment rate (27 June 2006))
First Posted : August 31, 2005
Last Update Posted : January 28, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Quetiapine fumarate Drug: sodium valproate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients
Study Start Date : July 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Arm Intervention/treatment
Active Comparator: 1
quetiapine fumarate monotherapy
Drug: Quetiapine fumarate
oral variable dose
Other Name: Seroquel

Experimental: 2
Quetiapine + sodium valproate
Drug: Quetiapine fumarate
oral variable dose
Other Name: Seroquel

Drug: sodium valproate

Primary Outcome Measures :
  1. The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate) [ Time Frame: after 2 weeks treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00139074

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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
Sponsors and Collaborators
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Principal Investigator: Dr. Rasmus Wenzer Licht AstraZeneca
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca

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Responsible Party: AstraZeneca Identifier: NCT00139074     History of Changes
Other Study ID Numbers: D1449L00010
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013
Keywords provided by AstraZeneca:
Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61)
Additional relevant MeSH terms:
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Quetiapine Fumarate
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents