Bipolar DisorderPhase 4GEVANSNCT00477373
Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
A Phase 4 study testing depakine chrono in people with Bipolar Disorder, run by Sanofi at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- depakine chrono
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Dec 2006to Dec 2007
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
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.
- Conditions
- Bipolar Disorder
- Being tested
- depakine chrono
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depakine chronoDrug
Depakine Chrono 500 mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: depakine chrono |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP)Severity score as well as the change in CGI-BP.
Measured: D0, D21 and D-end
Secondary outcomes (7)
Percentage of responders defined by a decrease of at least 50% of the CGI-BP.
Measured: D0 and D-end
Percentage of responders defined by a decrease of at least 50% of the CGI-BP.
Measured: D0 and D21
Time to achieve 50% and 30% improvement in the CGI-BP score.
Measured: From randomization to the end of the study
Time to a sustained improvement in the CGI-BP.
Measured: From randomization to the end of the study
Time to antidepressants use.
Measured: From randomization to the end of the study
Time to drop-out for any reason.
Measured: From randomization to the end of the study
Safety :Occurrence of any side effect leading to treatment discontinuation.
Measured: From inform consent signed until patient's recovery or stabilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2007 (estimated)
- Study startDec 2006
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hisham - MAHMOUD, MD, Study director, Sanofi-aventis administrative office Gulf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477373
- Sponsor's protocol ID
- DPKOT_L_01567
- Acronym
- GEVANS
- Status last verified
- Dec 2008
- First submitted
- 22 May 2007
- Last updated
- 19 Dec 2008
- Results posted
- No
- Data monitoring committee
- No