The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
403
Cariprazine was supplied in capsules.
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Forest Investigative Site 015
Springdale, Arkansas, United States
Forest Investigative Site 010
Carson, California, United States
Forest Investigative Site 020
Cerritos, California, United States
Forest Investigative Site 009
Escondido, California, United States
Forest Investigative Site 004
Garden Grove, California, United States
Forest Investigative Site 016
San Diego, California, United States
Forest Investigative Site 007
Santa Ana, California, United States
Forest Investigative Site 023
Washington D.C., District of Columbia, United States
Forest Investigative Site 001
Bradenton, Florida, United States
Forest Investigative Site 006
Fort Lauderdale, Florida, United States
...and 25 more locations