Clinical trial NCT00477373: Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
Official title: Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-05-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: The mean change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP)Severity score as well as the change in CGI-BP.
timeFrame: D0, D21 and D-end
Secondary outcomes:
measure: Percentage of responders defined by a decrease of at least 50% of the CGI-BP.
timeFrame: D0 and D-end
measure: Percentage of responders defined by a decrease of at least 50% of the CGI-BP.
timeFrame: D0 and D21
measure: Time to achieve 50% and 30% improvement in the CGI-BP score.
timeFrame: From randomization to the end of the study
measure: Time to a sustained improvement in the CGI-BP.
timeFrame: From randomization to the end of the study
measure: Time to antidepressants use.
timeFrame: From randomization to the end of the study
measure: Time to drop-out for any reason.
timeFrame: From randomization to the end of the study
measure: Safety :Occurrence of any side effect leading to treatment discontinuation.
timeFrame: From inform consent signed until patient's recovery or stabilization
Other outcomes:
Locations:
city: Bahrain
country: Bahrain
facility: Sanofi-aventis administrative office
city: Kuwait
country: Kuwait
facility: Sanofi-aventis administrative office
city: Muscat
country: Oman
facility: Sanofi-Aventis Administrative Office
city: Qatar
country: Qatar
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi-aventis administrative office Gulf
name: Hisham - MAHMOUD, MD
role: STUDY_DIRECTOR
References: