NCT00477373

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

December 19, 2008

Status Verified

December 1, 2008

Enrollment Period

1 year

First QC Date

May 22, 2007

Last Update Submit

December 18, 2008

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

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

    D0, D21 and D-end

Secondary Outcomes (7)

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

    D0 and D-end

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

    D0 and D21

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

    From randomization to the end of the study

  • Time to a sustained improvement in the CGI-BP.

    From randomization to the end of the study

  • Time to antidepressants use.

    From randomization to the end of the study

  • +2 more secondary outcomes

Study Arms (1)

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

Interventions

depakine chronoDRUG

Depakine Chrono 500 mg

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sanofi-aventis administrative office

Bahrain, Bahrain

Location

Sanofi-aventis administrative office

Kuwait City, Kuwait

Location

Sanofi-Aventis Administrative Office

Muscat, Oman

Location

Sanofi-aventis administrative office

Qatar, Qatar

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Hisham - MAHMOUD, MD

    Sanofi-aventis administrative office Gulf

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 22, 2007

First Posted

May 23, 2007

Study Start

December 1, 2006

Primary Completion

December 1, 2007

Last Updated

December 19, 2008

Record last verified: 2008-12

Locations

BA(1)QA(1)OM(1)KU(1)