Bipolar Disorders, Metabolic Complication
Conditions
Keywords
Bipolar disorder, metabolic complication, Aripiprazole, Weight gain, Clinical Trial, Antipsychotic, Metabolic syndrome, Psychopharmacology, Open Label
Brief summary
The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.
Detailed description
* reduced treatment adherence due to metabolic side effects * suggested advantages of aripiprazole in metabolic profile over other antipsychotics or mood stabilizers * randomized trial of switch from previous drugs to aripiprazole
Interventions
DRUGaripiprazole
dosage form : po recommended dosage : more than 10mg/day duration : 28 weeks
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV criteria * age between 18 and 65 * Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI - BP ≤ 3 * patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie \>7% weight gain)
Exclusion criteria
* diagnosis of eating disorder, substance abuse, and psychotic disorder * history of neurological and medical illness * pregnant or breast feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K | 0, 4, 8, 12, 18, 26 week |
Secondary
| Measure | Time frame |
|---|---|
| ECG prolactin SAS BAS UKU-SERS-Pat-Korean version | 0, 4, 8, 12, 18, 26 week |
Countries
South Korea
Outcome results
None listed