A Phase 3 interventional study of Cariprazine in Bipolar I Disorder, sponsored by Forest Laboratories. Completed at 35 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-06-13.
Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Cariprazine
Cariprazine was supplied in capsules.
Also known as: RGH-188
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
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
| Milestone | Cariprazine 3-12 mg/Day for 16 Weeks |
|---|---|
| Started | 403 |
| Completed | 132 |
| Not completed | 271 |
| Withdrew: Adverse event | 66 |
| Withdrew: Insufficient therapeutic response | 26 |
| Withdrew: Protocol violation | 55 |
| Withdrew: Withdrawal of consent | 80 |
| Withdrew: Lost to follow-up | 42 |
| Withdrew: Reason not specified | 2 |
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.
| Units on a scale | Cariprazine 3-12 mg/Day for 16 Weeks |
|---|---|
| Change From Baseline in the YMRS Total Score at Week 16 | -15.2 ± 9.2 |
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.
| Units on a scale | Cariprazine 3-12 mg/Day for 16 Weeks |
|---|---|
| Change From Baseline in the MADRS Total Score at Week 16 | -1.6 ± 7.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cariprazine 3-12 mg/Day for 16 Weeks | 0/402 (0%) | 34/402 (8.5%) | 293/402 (72.9%) |
| Event | Cariprazine 3-12 mg/Day for 16 Weeks |
|---|---|
| ManiaPsychiatric disorders | 9/402 |
| DepressionPsychiatric disorders | 5/402 |
| AkathisiaPsychiatric disorders | 3/402 |
| Suicidal ideationPsychiatric disorders | 2/402 |
| Suicide attemptPsychiatric disorders | 2/402 |
| Angina pectorisCardiac disorders | 1/402 |
| AnxietyPsychiatric disorders | 1/402 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 1/402 |
| Bipolar I disorderPsychiatric disorders | 1/402 |
| BradycardiaCardiac disorders | 1/402 |
| Event | Cariprazine 3-12 mg/Day for 16 Weeks |
|---|---|
| AkathisiaNervous system disorders | 129/402 |
| HeadacheNervous system disorders | 69/402 |
| ConstipationGastrointestinal disorders | 44/402 |
| NauseaGastrointestinal disorders | 42/402 |
| DyspepsiaGastrointestinal disorders | 38/402 |
| ToothacheGastrointestinal disorders | 35/402 |
| Back painMusculoskeletal and connective tissue disorders | 32/402 |
| TremorNervous system disorders | 31/402 |
| Extrapyramidal disorderNervous system disorders | 28/402 |
| InsomniaPsychiatric disorders | 27/402 |
Safety population: All enrolled participants who took at least 1 dose of investigational product.
| Age, Continuous(years) | Cariprazine 3-12 mg/Day for 16 Weeks |
|---|---|
| Mean | 41.4 ± 10.5 |
| Sex: Female, Male(Participants) | Cariprazine 3-12 mg/Day for 16 Weeks |
|---|---|
| Female | 172 |
| Male | 230 |
| Ethnicity (NIH/OMB)(Participants) | Cariprazine 3-12 mg/Day for 16 Weeks |
|---|---|
| Hispanic or Latino | 32 |
| Not Hispanic or Latino | 370 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Cariprazine 3-12 mg/Day for 16 Weeks |
|---|---|
| American Indian or Alaska Native | 6 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 182 |
| White | 206 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
| Weight(kg) | Cariprazine 3-12 mg/Day for 16 Weeks |
|---|---|
| Mean | 86.52 ± 17.83 |
| Body Mass Index (BMI)(kg/m^2) | Cariprazine 3-12 mg/Day for 16 Weeks |
|---|---|
| Mean | 29.21 ± 5.34 |
| Waist circumference(cm) | Cariprazine 3-12 mg/Day for 16 Weeks |
|---|---|
| Mean | 97.86 ± 14.05 |
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Forest Laboratories