Clareo Health | Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness
Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness
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Keep this study
Lead
Abbott
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DSM-IV-TR primary diagnosis of Bipolar I Disorder as confirmed by the SCID
Outpatient receiving treatment with a combination of Depakote plus olanzapine for their bipolar illness and considered clinically stable (e.g., no more than minimal symptoms, no psychiatric hospitalizations, no increase in intensity of clinical interventions) for the preceding 4 months
Identified at Screening a most bothersome side effect listed in the UKU which makes switching to monotherapy desirable
MRS total score \< 12 on two consecutive ratings, separated by at least 5 days (Screening and Day 1)
DSS score \< 13 on two consecutive ratings, separated by at least five days (Screening and Day 1)
CGI-S score \< 3 on two consecutive ratings, separated by at least five days (Screening and Day 1)
Serum valproate level \> 45 mcg/mL, and a maximum allowable dose of Depakote of 3000 mg/day at Screening
Olanzapine dose between 5 and 20 mg/day at Screening
You may not be if
History of schizophrenia or schizoaffective disorder
Axis I (e.g., anxiety disorder) or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
Has taken antipsychotics, mood stabilizers, or anticonvulsants (unless specifically for seizure control) other than Depakote or olanzapine in the four months prior to randomization. Other psychotropics (e.g., antidepressants, anxiolytics) with the exception of stimulants, that have been used routinely to maintain stability in the preceding four months may be continued, but not increased or decreased
Has first manic episode after age 60
Has ever taken clozapine
Has received depot neuroleptic medication within six months of randomization
Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
History of active alcohol or substance abuse/dependence within 90 days prior to Screening
Known history of non-response to either Depakote or olanzapine monotherapy for the treatment of bipolar disorder
