Bipolar Disorder
Conditions
Brief summary
The primary objective is: * To compare the efficacy of the association valproate-amisulpride (400 to 800 mg/day) to the association valproate-haloperidol (5 to 15 mg/day) in bipolar I patients suffering from a manic episode according to DSM IV TR (American Psychiatric Association \[APA\] 2000) and treated for a 3-month period. The secondary objectives are: * To evaluate the clinical and biological safety of the association valproate-amisulpride to the association valproate-haloperidol; * To assess the patient status 3 weeks and 3 months after inclusion; and * To assess patient satisfaction at 3 months.
Interventions
DRUGAmisulpride
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Pre-Inclusion Criteria on D-3: * In-patients * From 18 to 65 years old * Able to comply with the protocol * Having given their written informed consent (with a legal representative or a person of trust) * Current diagnosis of bipolar I disorder according to DSM IV TR (APA 2000) * Having had at least one manic episode in the past * Currently suffering from a manic episode according to DSM IV TR (APA 2000) * A minimum total score of 20 on the Young Mania Rating Scale (Y-MRS) at D-3 Inclusion Criteria on D0: * Having completed at least one day of the one to three-day washout period * A minimum total score of 20 on the Young Mania Rating Scale at D0 * A score of \> or = 3 for 2 of the following Y-MRS items: elevated mood; increased motor activity energy; sleep; content (grandiosity). * A score of \> or = 5 on the Clinical Global Impression Severity Scale for the severity of mania items at D0 * Using an effective contraception method (women of childbearing age only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combination of the percentage of responders defined by a decrease of at least 50% of the Y-MRS (Young Mania Rating Scale) between D0 and D END and the completion of the 3-month treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other efficacy criteria (such as the changes in Y-MRS scores between D0 and D 21, between D0 and D END.The percentage of remission defined as the Y-MRS < or = 12 at D END...). Safety data (clinical, ECG and laboratory data) | — |
Countries
Czechia, France, Poland, Slovakia, Spain
Outcome results
None listed