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
- Are there results?
- None posted in the registry
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
Show all 16Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
- ClinicalTrials.gov ID
- NCT00477373
- Acronym / sponsor ID
- GEVANS / DPKOT_L_01567
- Conditions
- Bipolar Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2007 (actual)
- First posted
- 23 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: depakine chronoIf 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| depakine chronoDepakine Chrono 500 mg | Drug | 1 |
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.
Time frame: D0, D21 and D-end
7 secondary outcomes
Percentage of responders defined by a decrease of at least 50% of the CGI-BP.
Time frame: D0 and D-end
Percentage of responders defined by a decrease of at least 50% of the CGI-BP.
Time frame: D0 and D21
Time to achieve 50% and 30% improvement in the CGI-BP score.
Time frame: From randomization to the end of the study
Time to a sustained improvement in the CGI-BP.
Time frame: From randomization to the end of the study
Time to antidepressants use.
Time frame: From randomization to the end of the study
Time to drop-out for any reason.
Time frame: From randomization to the end of the study
Safety :Occurrence of any side effect leading to treatment discontinuation.
Time frame: From inform consent signed until patient's recovery or stabilization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hisham - MAHMOUD, MD study director
Sanofi-aventis administrative office Gulf
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing depakine chrono in people with Bipolar Disorder, run by Sanofi at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Bahrain, Kuwait, Oman, Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: D0, D21 and D-end). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2008.