Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
NCT ID: NCT00477373
Last Updated: 2008-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2006-12-31
Brief Summary
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To evaluate the clinical safety of Di-valproate.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
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.
depakine chrono
Depakine Chrono 500 mg
Interventions
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depakine chrono
Depakine Chrono 500 mg
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Hisham - MAHMOUD, MD
Role: STUDY_DIRECTOR
Sanofi-aventis administrative office Gulf
Locations
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Sanofi-aventis administrative office
Bahrain, , Bahrain
Sanofi-aventis administrative office
Kuwait City, , Kuwait
Sanofi-Aventis Administrative Office
Muscat, , Oman
Sanofi-aventis administrative office
Qatar, , Qatar
Countries
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Other Identifiers
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DPKOT_L_01567
Identifier Type: -
Identifier Source: org_study_id