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:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00139074
First received: August 29, 2005
Last updated: January 25, 2013
Last verified: January 2013
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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:
MedlinePlus related topics:
Bipolar Disorder
Drug Information available for:
Formic acid
Valproic acid
Valproate sodium
Divalproex sodium
Quetiapine
Quetiapine fumarate
U.S. FDA Resources
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
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 May 21, 2013