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Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: depakine chrono (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Hisham - MAHMOUD, MD, Study Director, Affiliation: Sanofi-aventis administrative office Gulf

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.

Clinical Details

Official title: Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The mean change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP)Severity score as well as the change in CGI-BP.

Secondary outcome:

Percentage of responders defined by a decrease of at least 50% of the CGI-BP.

Percentage of responders defined by a decrease of at least 50% of the CGI-BP.

Time to achieve 50% and 30% improvement in the CGI-BP score.

Time to a sustained improvement in the CGI-BP.

Time to antidepressants use.

Time to drop-out for any reason.

Safety :Occurrence of any side effect leading to treatment discontinuation.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

Sanofi-aventis administrative office, Bahrain, Bahrain

Sanofi-aventis administrative office, Kuwait, Kuwait

Sanofi-Aventis Administrative Office, Muscat, Oman

Sanofi-aventis administrative office, Qatar, Qatar

Additional Information

Starting date: December 2006
Last updated: December 18, 2008

Page last updated: August 20, 2015

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