A Phase 3 interventional study of Cariprazine and Placebo in Bipolar Disorder and Mania, sponsored by Forest Laboratories. Completed at 28 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-17.
Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
Exclusion Criteria:
Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Drug: Cariprazine
Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Drug: Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo.
Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3
The YMRS is an 11-item scale that assesses manic symptoms based on the participant'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 the abnormality for 7-items are rated on a 5-point scale (0-4) and 4-items on a 9-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis was a mixed model for repeated measurements (MMRM) observed cases (OC), with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
Time frame: Baseline, Week 3
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3
The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7=Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis was based on a MMRM using the observed cases (OC) data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
Time frame: Baseline, Week 3
| Milestone | Placebo | Cariprazine |
|---|---|---|
| Started | 154 | 158 |
| Completed | 106 | 108 |
| Not completed | 48 | 50 |
| Withdrew: Adverse event | 11 | 15 |
| Withdrew: Insufficient therapeutic response | 16 | 7 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Withdrawal of consent | 17 | 26 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Other unspecified | 2 | 0 |
| Milestone | Placebo | Cariprazine |
|---|---|---|
| Started | 133 | 134 |
| Completed | 129 | 130 |
| Not completed | 4 | 4 |
The YMRS is an 11-item scale that assesses manic symptoms based on the participant'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 the abnormality for 7-items are rated on a 5-point scale (0-4) and 4-items on a 9-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis was a mixed model for repeated measurements (MMRM) observed cases (OC), with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
| score on a scale | Placebo | Cariprazine |
|---|---|---|
| Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 | -15.3 ± 0.9 | -19.6 ± 0.9 |
The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7=Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis was based on a MMRM using the observed cases (OC) data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
| score on a scale | Placebo | Cariprazine |
|---|---|---|
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 | -1.3 ± 0.1 | -1.6 ± 0.1 |
Collected over First dose of study drug to 30 days past last dose (Up to 51 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 5/154 (3.2%) | 69/154 (44.8%) |
| Cariprazine | — | 6/158 (3.8%) | 110/158 (69.6%) |
| Event | Placebo | Cariprazine |
|---|---|---|
| ManiaPsychiatric disorders | 1/154 | 3/158 |
| Hepatitis EInfections and infestations | 1/154 | 0/158 |
| Social stay hospitalisationSocial circumstances | 1/154 | 0/158 |
| Bipolar disorderPsychiatric disorders | 1/154 | 0/158 |
| Non-cardiac chest painGeneral disorders | 1/154 | 0/158 |
| AkathisiaNervous system disorders | 0/154 | 1/158 |
| ConvulsionNervous system disorders | 0/154 | 1/158 |
| Suicidal ideationPsychiatric disorders | 0/154 | 1/158 |
| Event | Placebo | Cariprazine |
|---|---|---|
| AkathisiaNervous system disorders | 8/154 | 35/158 |
| Extrapyramidal DisorderNervous system disorders | 3/154 | 24/158 |
| TremorNervous system disorders | 9/154 | 19/158 |
| HeadacheNervous system disorders | 16/154 | 18/158 |
| DyspepsiaGastrointestinal disorders | 7/154 | 17/158 |
| NauseaGastrointestinal disorders | 10/154 | 16/158 |
| VomitingGastrointestinal disorders | 7/154 | 16/158 |
| ConstipationGastrointestinal disorders | 10/154 | 14/158 |
| DizzinessNervous system disorders | 6/154 | 14/158 |
| DiarrhoeaGastrointestinal disorders | 6/154 | 11/158 |
Safety Population included all randomized participants who took at least 1 dose of double-blind investigational product.
| Age, Continuous(years) | Placebo | Cariprazine | Total |
|---|---|---|---|
| Mean | 36.7 ± 11.8 | 35.8 ± 11.4 | 36.3 ± 11.5 |
| Sex: Female, Male(Participants) | Placebo | Cariprazine | Total |
|---|---|---|---|
| Female | 59 | 53 | 112 |
| Male | 95 | 105 | 200 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Cariprazine | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 5 | 10 |
| Not Hispanic or Latino | 149 | 153 | 302 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Placebo | Cariprazine | Total |
|---|---|---|---|
| White | 33 | 33 | 66 |
| Black/African American | 29 | 33 | 62 |
| Asian | 88 | 91 | 179 |
| American Indian or Alaska Native | 3 | 0 | 3 |
| Other | 1 | 1 | 2 |
| Weight(kilogram (kg)) | Placebo | Cariprazine | Total |
|---|---|---|---|
| Mean | 71.86 ± 20.27 | 69.55 ± 20.06 | 70.69 ± 20.17 |
| Height(centimeter (cm)) | Placebo | Cariprazine | Total |
|---|---|---|---|
| Mean | 166.39 ± 10.64 | 165.21 ± 10.68 | 165.79 ± 10.66 |
| Body Mass Index (BMI)(kg/meter(m)^2) | Placebo | Cariprazine | Total |
|---|---|---|---|
| Mean | 25.73 ± 5.98 | 25.24 ± 5.98 | 25.48 ± 5.98 |
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Forest Laboratories