Status:
COMPLETED
Valproic Acid Sodium Salt in Bipolar Disorder
Lead Sponsor:
Sanofi
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
* To determine the total and local gray matter volumes, and N-acetyl aspartate (NAA) levels in patients with bipolar disorders who are within euthimic, depressive or manic/hypomanic period and who are...
Eligibility Criteria
Inclusion
- diagnosis of type I or II bipolar disorder according to DSM-IV after stratified SCID I interview,
- being currently euthimic (for at least one month), manic-hypomanic and having YMRS points of 15 or more, or being in depressive episode and having HAM-D21 points of 15 or more
- being not taking drugs for at least two weeks before participating in the study (except benzodiazepins)
Exclusion
- female who are pregnant or planning to be pregnant, nursing
- having known hypersensitivity to study drug
- being given any psychotropic agent other than benzodiazepine within the last two weeks
- active sustance or alcohol usage within the last two weeks, or substance addiction other than cafein or nicotine (within the last month)
- having another axis I disorder such as comorbid dementia, delirium, obsessive compulsive disorder, eating disorder
- having unstabilised hepatic or renal disorder, thyroid or blood disease
- having history of cerebral surgery
- existence of a degenerative neurologic disease or epilepsy
- having pacemaker
- having a prosthesis able to magnetic effect in eye, brain or sites near to these regions
- homicide thougths or severe catatonia required to be hospitalized
- having mixed episode
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00431522
Start Date
December 1 2004
End Date
October 1 2006
Last Update
May 29 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Istanbul, Turkey (Türkiye)