Bipolar I Disorder
Conditions
Brief summary
The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with Bipolar I Disorder.
Interventions
DRUGIloperidone
Oral iloperidone
DRUGIloperidone Placebo
Oral placebo
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients 18 to 65 years of age (inclusive) * Diagnosed with bipolar I disorder, manic or mixed-type, per DSM-5 criteria * Voluntary hospitalization for current manic episode
Exclusion criteria
* Patients with a DSM-5 diagnosis of a psychiatric disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months * Patients who are experiencing a first manic episode or meeting criteria for rapid cycling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score | Week 4 | The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst). |
Countries
Bulgaria, Poland, United States
Participant flow
Pre-assignment details
Safety analyses included patients who received 1 or more doses of study medication. Of the 417 randomized, 414 received at least one dose of study medication.
Participants by arm
| Arm | Count |
|---|---|
| Iloperidone Iloperidone: Oral iloperidone | 206 |
| Placebo Iloperidone Placebo: Oral placebo | 208 |
| Total | 414 |
Baseline characteristics
| Characteristic | Iloperidone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 42.9 years STANDARD_DEVIATION 12.76 | 43.9 years STANDARD_DEVIATION 12.55 | 43.4 years STANDARD_DEVIATION 12.65 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 62 Participants | 55 Participants | 117 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 15 Participants | 24 Participants |
| Race/Ethnicity, Customized White | 133 Participants | 132 Participants | 265 Participants |
| Sex: Female, Male Female | 90 Participants | 96 Participants | 186 Participants |
| Sex: Female, Male Male | 116 Participants | 112 Participants | 228 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 206 | 0 / 208 |
| other Total, other adverse events | 88 / 206 | 25 / 208 |
| serious Total, serious adverse events | 4 / 206 | 1 / 208 |
Outcome results
Primary
Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score
The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst).
Time frame: Week 4
Population: Efficacy analyses were based on the Intent-To-Treat (ITT) population, which included all randomized patients who received a dose of study drug and had at least one valid post-baseline efficacy measurement while on study medication. Of the 417 randomized, 392 received at least one dose of study medication and had at least one valid post-baseline efficacy measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iloperidone | Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score | -14.0 Change from Baseline in YMRS Total Score | Standard Error 0.64 |
| Placebo | Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score | -10.0 Change from Baseline in YMRS Total Score | Standard Error 0.63 |