Bipolar I Disorder
Conditions
Keywords
Mania, Acute mania, Bipolar I disorder
Brief summary
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
Interventions
DRUGCariprazine
Cariprazine was supplied in capsules.
Sponsors
Gedeon Richter Ltd.
Forest Laboratories
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
* Patients who have provided informed consent prior to any study specific procedures. * Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID). * Patients who experienced a manic or mixed episode that required treatment within the past 12 months. * Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).
Exclusion criteria
* Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the YMRS Total Score at Week 16 | Baseline to Week 16 | The Young Mania Rating Scale (YMRS) is an 11-item scale that assesses manic symptoms based on the patient's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11 items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of each item is rated on a 5-point (0-4) or a 9-point (0-8) scale. The total score of all 11 items can range from 0 to 60. A higher score indicates worse manic symptoms. A negative change score indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the MADRS Total Score at Week 16 | Baseline to Week 16 | The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated scale that evaluates the patient's depressive symptomatology during the previous week. Patients are rated on 10 items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point (0-6) scale. The total score can range from 0 to 42. A higher score indicates greater depressive symptomatology. A negative change score indicates improvement. |
Countries
Hungary, Poland, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cariprazine 3-12 mg/Day for 16 Weeks Participants received cariprazine 1.5 mg orally on Day 1 and cariprazine 3.0 mg orally on Days 2 and 3. Starting on Day 4, the dose could be increased in increments of 3 mg every 2 days up to a maximum dose of 12 mg, if the response was not adequate and there were no tolerability issues based on the judgment of the principal investigator. | 402 |
| Total | 402 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 66 |
| Overall Study | Insufficient Therapeutic Response | 26 |
| Overall Study | Lost to Follow-up | 42 |
| Overall Study | Protocol Violation | 55 |
| Overall Study | Reason Not Specified | 2 |
| Overall Study | Withdrawal of Consent | 80 |
Baseline characteristics
| Characteristic | Cariprazine 3-12 mg/Day for 16 Weeks |
|---|---|
| Age, Continuous | 41.4 years STANDARD_DEVIATION 10.5 |
| Body Mass Index (BMI) | 29.21 kg/m^2 STANDARD_DEVIATION 5.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 370 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 182 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 206 Participants |
| Sex: Female, Male Female | 172 Participants |
| Sex: Female, Male Male | 230 Participants |
| Waist circumference | 97.86 cm STANDARD_DEVIATION 14.05 |
| Weight | 86.52 kg STANDARD_DEVIATION 17.83 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 402 |
| other Total, other adverse events | 293 / 402 |
| serious Total, serious adverse events | 34 / 402 |
Outcome results
Primary
Change From Baseline in the YMRS Total Score at Week 16
The Young Mania Rating Scale (YMRS) is an 11-item scale that assesses manic symptoms based on the patient's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11 items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of each item is rated on a 5-point (0-4) or a 9-point (0-8) scale. The total score of all 11 items can range from 0 to 60. A higher score indicates worse manic symptoms. A negative change score indicates improvement.
Time frame: Baseline to Week 16
Population: Intent-to-treat population: All enrolled participants who took at least 1 dose of investigational product and who had a Baseline and at least 1 post-baseline assessment of the Young Mania Rating Scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cariprazine 3-12 mg/Day for 16 Weeks | Change From Baseline in the YMRS Total Score at Week 16 | -15.2 Units on a scale | Standard Deviation 9.2 |
Secondary
Change From Baseline in the MADRS Total Score at Week 16
The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated scale that evaluates the patient's depressive symptomatology during the previous week. Patients are rated on 10 items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point (0-6) scale. The total score can range from 0 to 42. A higher score indicates greater depressive symptomatology. A negative change score indicates improvement.
Time frame: Baseline to Week 16
Population: Intent-to-treat population: All enrolled participants who took at least 1 dose of investigational product and who had a Baseline and at least 1 post-baseline assessment of the Young Mania Rating Scale.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cariprazine 3-12 mg/Day for 16 Weeks | Change From Baseline in the MADRS Total Score at Week 16 | -1.6 Units on a scale | Standard Deviation 7.5 |