Bipolar Disorder, Metabolic Syndrome
Conditions
Keywords
bipolar disorder, sedation, overweight, Abilify, medication
Brief summary
The proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention of 50 obese or overweight adults diagnosed with bipolar disorder. The study will be divided in three steps: Screening, Baseline Period (cross taper to aripiprazole, up to 2 months in duration), Months 1-3 (continued aripiprazole treatment). Subjects will be assessed and meet with their study psychiatrist at least bi-monthly throughout their participation, more frequently when clinically necessary (e.g. during medication tapering or if manic/depressive symptoms emerge). Brief clinical assessments will be conducted at each visit. More thorough assessments will be conducted at Baseline, Week 2, and Month 3.
Interventions
DRUGAripiprazole
All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic.
Sponsors
Bristol-Myers Squibb
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 65 years 2. Body mass index (BMI) \>=25; 3. Currently taking a regimen of medications for bipolar disorder likely to cause, sedation, weight gain or undesirable metabolic effects; 4. Able to give basic informed consent 5. Meets DSM-IV criteria for lifetime bipolar I or II disorder and are presently in sustained remission (CGI BP\<3 in the previous 8-week period measured through a complete psychiatric history at screening and patient report.) 6. Epworth Scale Score \> 7 7. Women of childbearing potential must agree to use a doctor-approved birth control throughout participation in the study
Exclusion criteria
1. Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations) 2. Not competent to provide informed consent in the opinion of the investigator 3. Ultra-rapid cycling (\>4 episodes per month) bipolar I disorder 4. Unstable and severe medical illness that requires immediate and intensive medical attention, When appropriate, the patients can be reconsidered for inclusion in the study if/when their medical condition becomes compatible with participation in a protocol-driven research study 5. Women who are planning to become pregnant, currently pregnant, or breast-feeding; 6. Current substance dependence; however, if a subject only has substance abuse/use, after the first positive drug screen, another drug screen will be repeated. If that drug screen is positive, the subject will be excluded. If the second drug screen is negative, the subject will be considered for the study; 7. Subjects who have previously failed an adequate trial of aripiprazole. 8. Subjects with a suicide attempt in the past 2 years; 9. Subjects with a history of inpatient admission in the past 1 year; 10. Subjects with a history of homicidal ideation; 11. Any subject for whom the PI deems that the potential risks in participating in the study outweigh the potential benefits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns), | 3 months |
| Epworth Sleepiness Scale (General Level of Daytime Sleepiness) | 3 month |
Secondary
| Measure | Time frame |
|---|---|
| Global Assessment of Functioning | 3 months |
| Quality of Life Enjoyment Questionnaire | 3 months |
| Young Mania Rating Scale | 3 months |
| Hamilton Rating Scale for Depression | 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aripiprazole Aripiprazole
Aripiprazole: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Study Terminated by Study Sponsor | 1 |
Baseline characteristics
| Characteristic | Aripiprazole |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 56.7 years STANDARD_DEVIATION 4.7 |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
BodyMedia Armband (Sleep/Wake and Activity/Inactivity Patterns),
Time frame: 3 months
Population: 0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.
Primary
Epworth Sleepiness Scale (General Level of Daytime Sleepiness)
Time frame: 3 month
Population: 0-the study was terminated early by the study sponsor due to low enrollment numbers. Only one participant completed the study in its duration and the study was terminated before any outcome data could be analyzed.
Secondary
Global Assessment of Functioning
Time frame: 3 months
Population: Study was terminated early and data were not collected for this outcome.
Secondary
Hamilton Rating Scale for Depression
Time frame: 3 months
Population: Study was terminated early and data were not collected for this outcome.
Secondary
Quality of Life Enjoyment Questionnaire
Time frame: 3 months
Population: Study was terminated early and data were not collected for this outcome.
Secondary
Young Mania Rating Scale
Time frame: 3 months
Population: Study was terminated early and data were not collected for this outcome.