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

This study has been terminated.
(terminated due to very low recruitment rate (27 June 2006))
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00139074
First received: August 29, 2005
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Bipolar Disorder
Drug: Quetiapine fumarate
Drug: sodium valproate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate) [ Time Frame: after 2 weeks treatment ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: July 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
oral

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139074

Locations
Denmark
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
AstraZeneca
Investigators
Principal Investigator: Dr. Rasmus Wenzer Licht AstraZeneca
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00139074     History of Changes
Other Study ID Numbers: D1449L00010
Study First Received: August 29, 2005
Last Updated: January 25, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by AstraZeneca:
Bipolar I Disorder (DSM-IV 296.01, DSM-IV 296.4, DSM-IV 296.61)

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Valproic Acid
Quetiapine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipsychotic Agents

ClinicalTrials.gov processed this record on July 24, 2014