Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Clareo Health | Gulf Evaluation of VAlproate (Depakine Chrono) in maNia Study
