Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00477373

Purpose

To assess the efficacy of Di-valproate in Bipolar I patients suffering from a manic episode according to DSM IV (APA 1994) over a 12 weeks period of treatment.

To evaluate the clinical safety of Di-valproate.

Condition	Intervention	Phase
Bipolar Disorder	Drug: depakine chrono	Phase IV

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

The mean change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP)Severity score as well as the change in CGI-BP. [ Time Frame: D0, D21 and D-end ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of responders defined by a decrease of at least 50% of the CGI-BP. [ Time Frame: D0 and D-end ] [ Designated as safety issue: No ]
Percentage of responders defined by a decrease of at least 50% of the CGI-BP. [ Time Frame: D0 and D21 ] [ Designated as safety issue: No ]
Time to achieve 50% and 30% improvement in the CGI-BP score. [ Time Frame: From randomization to the end of the study ] [ Designated as safety issue: No ]
Time to a sustained improvement in the CGI-BP. [ Time Frame: From randomization to the end of the study ] [ Designated as safety issue: No ]
Time to antidepressants use. [ Time Frame: From randomization to the end of the study ] [ Designated as safety issue: No ]
Time to drop-out for any reason. [ Time Frame: From randomization to the end of the study ] [ Designated as safety issue: No ]
Safety :Occurrence of any side effect leading to treatment discontinuation. [ Time Frame: From inform consent signed until patient's recovery or stabilization ] [ Designated as safety issue: Yes ]

Enrollment:	70
Study Start Date:	December 2006
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental If the daily dose does not exceed 1000 mg, Depakine CHRONO can be administered once a day. If the dose is greater than 1000 mg/day, Depakine CHRONO will be administered in a bid regimen: one tablet in the morning and one tablet in the evening.	Drug: depakine chrono Depakine Chrono 500 mg

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

In or out patients
Patients with a current diagnosis of Bipolar I Disorder according to DSM IV (296)
Patients suffering from a current manic episode or mixed episode

Exclusion Criteria:

Patients who participated in a clinical trial within the three preceding months
Patients with a history of valproate intolerance defined as valproate discontinuation due to medically significant adverse effects.
Patients with a CNS neoplasm, demyelinating disease, degenerative neurological disorder, active CNS infection or any progressive disorder
Patients with a history of seizure disorder, cerebral vascular disease, structural brain damage from trauma, clinically significant focal neurological abnormalities, known EEG with frank paroxysmal activity or a known CT scan of the brain demonstrating gross structural abnormalities
Patients with uncontrolled gastro-intestinal, renal, hepatic, endocrine, cardiovascular, pulmonary, immunological or hematological disease
Patients with acute or chronic hepatitis
Patients with current or past pancreatitis
Patients with recent history (3 months or less) of substance or alcohol dependence according to DSM IV
Pregnancy or lactation. Women of child bearing age should be using a reliable contraceptive method
Patients that require more than 325 mg of aspirin per day
Patients with a medical condition which requires the continuous use of medication which could interfere with the evaluation of safety or efficacy of valproate : anticonvulsant or anticoagulant therapy, MAO inhibitors, zidovudine
Patients having received any depot neuroleptic within six weeks prior to baseline
Patients who received antidepressant drugs within 5 days before baseline and patients who received fluoxetine within 20 days
Patients judged by the investigator to have serious risk of suicide
Patients necessitating an Electro Convulsive Therapy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477373

Locations

Bahrain
Sanofi-aventis administrative office
Bahrain, Bahrain
Kuwait
Sanofi-aventis administrative office
Kuwait, Kuwait
Oman
Sanofi-Aventis Administrative Office
Muscat, Oman
Qatar
Sanofi-aventis administrative office
Qatar, Qatar

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Hisham - MAHMOUD, MD

Sanofi-aventis administrative office Gulf

More Information

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	DPKOT_L_01567
Study First Received:	May 22, 2007
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00477373
Health Authority:	Kuwait: Ministry of Health

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Valproic Acid

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors

Antimanic Agents
Pharmacologic Actions
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009