Bipolar DisorderPhase 4NCT00264173
VALID : VAlproate Versus LIthium in Bipolar Disorders
A Phase 4 study testing Valproate sodium in people with Bipolar Disorder, run by Sanofi.
Trial summary
Primary Objective : To compare the efficacy of valproate to lithium in Bipolar I patients suffering from a manic or a mixed episode according to DSM IV TR (APA 2000) [Diagnostic and Statistical Manual of Mental Disorders (DSM) fourth edition (IV)Text Revision (TR)] and over a periode of 3 weeks and 12 weeks of… 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?
- Valproate sodium
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Sep 2006
- 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
- Patients with a history of at least one manic episode in the previous three years or before the age of 60 for patients older than 60 at screening, as documented by medical records, or by a relative's report of information corroborating evidence of manic symptomatology for patients already known as bipolar patients. Newly diagnosed patients for bipolar disorder are allowed provided that the diagnosis is based on DSM IV TR[Diagnostic and Statistical Manual of Mental Disorders (DSM) fourth edition (IV)Text Revision (TR)]and that the patient is less than 30 years old.
- Patients with a current diagnosis of Bipolar I Disorder according to DSM IV TR
- Patients suffering from a current manic episode or a mixed episode according to DSM IV TR
- Patients with a minimum total score on the Young Mania Rating Scale (YMRS)of 18 at Screening
- Patients having completed the wash-out period of at least 1 day duration (except for patients receiving no psychiatric treatment or a benzodiazepine at a dose lower than the equivalence of 8 mg of lorazepam and except for patients who only received injectable long-acting neuroleptics at least 7 days prior to Screening)
- Patients with a minimum total score on the Young Mania Rating Scale (YMRS) of 18 at D0
Who cannot join
- Participation in a clinical trial within the three previous months
- Patients with a history of valproate intolerance defined as valproate discontinuation due to medically significant adverse effects
- Patients with a history of lithium intolerance defined as lithium discontinuation due to medically significant adverse effects
- Patients with a Central Nervous System (CNS) neoplasm, demyelinating disease, degenerative neurological disorder, active CNS infection or any progressive disorder that may blur interpretation of the study results
- Patients with a history of seizure disorder, cerebrovascular disease, structural brain damage from trauma, clinically significant focal neurological abnormalities, known EEG (Electroencephalography) 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
Show all 27Show fewer
- Patients with renal insufficiency, cardiac insufficiency and Addison's disease
- Patients with past or current pancreatitis
- Patients with acute hepatitis, chronic hepatitis, or family history of severe hepatitis especially drug related, hepatic porphyry
- Patients with a current DSM IV diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence) or substance abuse with stimulants including but not limited to cocaine, heroin, crack, amphetamines, pseudo-ephedrine, cold medications with phenylephrine or other stimulants. Alcohol or marijuana abuse prior to study entry will be accepted if related to the current manic episode, based on the investigator's judgment
- Pregnancy or lactation. Women of child bearing age should therefore be using a reliable contraceptive method
- Patients that require more than 300 mg of aspirin per day
- Patients with a medical condition which requires the continuous use of a treatment which could interfere with the safety or efficacy evaluation of valproate (anticonvulsant or anticoagulant therapy, zidovudine) or lithium (angiotensin converting enzyme inhibitors, tetracycline, reserpine, calcium channel blockers, triptans)
- Patients who received injectable long-acting neuroleptics less than 7 days prior to Screening
- Patients necessitating an Electro Convulsive Therapy
- Congenital prolongation of the QT interval
- Patients treated with an antidepressant within 5 days prior to randomization (D0)or with fluoxetine within 20 days preceding D0
- Patients with alterations of laboratory tests of potential significance:
- ASAT or ALAT > 3 ULN (Upper Limit of Normal)
- Alkaline phosphatase level > 1.5 ULN
- Serum creatinine > or = to 150 µmol/l
- Hemoglobin < 12 g/dl (men) and <11 g/dl (women)
- Platelets < 150 000 /mm3
- Neutrophils < 1 500 /mm3
- Prothrombin time < 75 %
- TSH (Thyroid-Stimulating Hormone)out of normal ranges
- QTc Bazett > 450 ms for male and > 470 ms for female on ECG (Electrocardiogram).
About this study
Official title: A Twelve-Week, Open, Randomized Trial Comparing Valproate to Lithium in Bipolar I Patients Suffering From a Manic Episode
Primary Objective :
- To compare the efficacy of valproate to lithium in Bipolar I patients suffering from a manic or a mixed episode according to DSM IV TR (APA 2000) [Diagnostic and Statistical Manual of Mental Disorders (DSM) fourth edition (IV)Text Revision (TR)] and over a periode of 3 weeks and 12 weeks of treatment
Secondary Objective :
- To evaluate the clinical and biological safety of valproate compared to lithium.
- Conditions
- Bipolar Disorder
- Being tested
- Valproate sodium
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproate sodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to D END in the Young Mania Rating Scale total score
Secondary outcomes (8)
Change from baseline to each assessment in the YMRS score
Percentage of responders defined by a decrease of at least 50% in the YMRS score between D0 and D END
Percentage of responders at week 3 defined by a decrease of at least 50 % in the YMRS score between D0 and D21
Change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) (20) between D0 and D21
Change in the CGI-BP between D0 and D END
Change in the MADRS between D0 and D21 (MADRS: Montgomery and Asberg Depression Rating Scale )
Change in the MADRS between D0 and D END
Survival analyses: Time to achieve 50% and 30% improvement in the YMRS score; Time to antidepressant intake; Time to drop-out for any reason.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startFeb 2004
- Study completionSep 2006
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert MANFREDI, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264173
- Sponsor's protocol ID
- R_8740
- Status last verified
- Nov 2007
- First submitted
- 9 Dec 2005
- Last updated
- 16 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve-Week, Open, Randomized Trial Comparing Valproate to Lithium in Bipolar I Patients Suffering From a Manic Episode
- ClinicalTrials.gov ID
- NCT00264173
- Acronym / sponsor ID
- R_8740
- Conditions
- Bipolar Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 12 Dec 2005 (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.
Primary Objective :
- To compare the efficacy of valproate to lithium in Bipolar I patients suffering from a manic or a mixed episode according to DSM IV TR (APA 2000) [Diagnostic and Statistical Manual of Mental Disorders (DSM) fourth edition (IV)Text Revision (TR)] and over a periode of 3 weeks and 12 weeks of treatment
Secondary Objective :
- To evaluate the clinical and biological safety of valproate compared to lithium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a history of at least one manic episode in the previous three years or before the age of 60 for patients older than 60 at screening, as documented by medical records, or by a relative's report of information corroborating evidence of manic symptomatology for patients already known as bipolar patients. Newly diagnosed patients for bipolar disorder are allowed provided that the diagnosis is based on DSM IV TR[Diagnostic and Statistical Manual of Mental Disorders (DSM) fourth edition (IV)Text Revision (TR)]and that the patient is less than 30 years old.
- Patients with a current diagnosis of Bipolar I Disorder according to DSM IV TR
- Patients suffering from a current manic episode or a mixed episode according to DSM IV TR
- Patients with a minimum total score on the Young Mania Rating Scale (YMRS)of 18 at Screening
- Patients having completed the wash-out period of at least 1 day duration (except for patients receiving no psychiatric treatment or a benzodiazepine at a dose lower than the equivalence of 8 mg of lorazepam and except for patients who only received injectable long-acting neuroleptics at least 7 days prior to Screening)
Key exclusion criteria (27 listed)
- Participation in a clinical trial within the three previous months
- Patients with a history of valproate intolerance defined as valproate discontinuation due to medically significant adverse effects
- Patients with a history of lithium intolerance defined as lithium discontinuation due to medically significant adverse effects
- Patients with a Central Nervous System (CNS) neoplasm, demyelinating disease, degenerative neurological disorder, active CNS infection or any progressive disorder that may blur interpretation of the study results
- Patients with a history of seizure disorder, cerebrovascular disease, structural brain damage from trauma, clinically significant focal neurological abnormalities, known EEG (Electroencephalography) with frank paroxysmal activity or a known CT scan of the brain demonstrating gross structural abnormalities
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 |
|---|---|---|
| Valproate sodium | Drug | – |
Primary outcome
Change from baseline to D END in the Young Mania Rating Scale total score
8 secondary outcomes
Change from baseline to each assessment in the YMRS score
Percentage of responders defined by a decrease of at least 50% in the YMRS score between D0 and D END
Percentage of responders at week 3 defined by a decrease of at least 50 % in the YMRS score between D0 and D21
Change in the Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) (20) between D0 and D21
Change in the CGI-BP between D0 and D END
Change in the MADRS between D0 and D21 (MADRS: Montgomery and Asberg Depression Rating Scale )
Change in the MADRS between D0 and D END
Survival analyses: Time to achieve 50% and 30% improvement in the YMRS score; Time to antidepressant intake; Time to drop-out for any reason.
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 16 Nov 2007.
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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.
Robert MANFREDI, MD study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valproate sodium in people with Bipolar Disorder, run by Sanofi.
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 6 inclusion and 27 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 16 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline to D END in the Young Mania Rating Scale total score. 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 16 Nov 2007.