Positive Topline Results from Phase 3 Study of Cariprazine for the Treatment of Bipolar I Depression

MedicalResearch.com Interview with:
Gary Sachs, MD
Associate Clinical Professor of Psychiatry
Harvard Medical School 

MedicalResearch.com: What is the background for this data milestone?

Response: Bipolar disorder affects about 5.7 million adults in the United States.  It is a common, often disabling condition in which abnormal mood states impair a person’s ability to carry out everyday tasks. Bipolar disorder touches nearly every family and community in America, because periods of illness, a patient’s symptoms often impact their family, their friends, and their community.

There are a limited number of products approved to treat bipolar depression and even fewer products that have been studied and approved to treat the full spectrum of bipolar disorder, from mania through depression. Having another product proven to treat the full range of bipolar disorder would be a welcome addition to the treatment options currently available to the psychiatry community and patients.

MedicalResearch.com: What are the main findings of the study?

 Response: This phase 3 trial (RGH-MD-54), is the second positive trial of cariprazine for Bipolar depression. A total of 488 patients were randomized in this study aiming to evaluate the efficacy, safety, and tolerability of cariprazine 1.5 mg/day and 3.0 mg/day compared to placebo in patients with bipolar I depression.

The primary efficacy objective was met for both cariprazine 1.5 and 3mg dose groups. Both showed a significantly greater improvement than placebo for the change from baseline to week 6 on the Montgomery-Asberg Depression Rating Scale (MADRS) total score.

MedicalResearch.com: What should readers take away from this announcement?

Response: The depressed phase of the illness is the most common entry point for patients seeking treatment and is associated with most of the disability and risk of suicide associated with bipolar disorder.  For patients with bipolar depression, cariprazine should be added to what is still a rather short list of agents with efficacy proven in a fully powered double blind clinical trial (Olanzapine in combination with Fluoxetine, Olanzapine, Quetiapine,  lamotrigine, lurasidone, and now cariprazine).

I was taught to offer patients proven treatments first.  Positive data from a well-controlled trial enables me to add cariprazine to the menu of reasonable options I offer my patients.

Second, since patients with bipolar disorder may experience transitions directly from depression to mania or mania to depression as well as mixed states, cariprazpine which also has proven efficacy for treatment of mania and mixed episodes, provides a broad spectrum option.

As clinicians, it is our goal to improve the severity of the mood changes associated with bipolar disorder, which can cause significant personal distress, and can often have serious implications for a patient’s health. These new data for cariprazine indicate that it could potentially be an effective new treatment option for people struggling to manage major depressive episodes associated with bipolar I disorder.

MedicalResearch.com: Is there anything else you would like to add about the data and what it means for people living with bipolar I depression?

Response: Bipolar disorder varies greatly from person to person, and so does the right medication. More treatment options are needed so that physicians can find a treatment that works best for each individual. With this trial, Allergan will have sufficient data to submit to the U.S. Food and Drug Administration so that cariprazine may be evaluated as a potential new treatment option for adults struggling to manage their bipolar I depression.

Do you have any relevant financial disclosures that we should note?

I have a consulting agreement with Allergan under which my fees are donated to the Depression and Bipolar Support Alliance. 

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.


Allergan and Richter Announce Positive Topline Results from Phase 3 Study of Cariprazine for the Treatment of Bipolar I Depression

Primary endpoint was met in the study evaluating patients with acute bipolar I depression treated with cariprazine 1.5 mg and 3 mg versus placebo

Allergan plans to submit Supplemental New Drug Application (sNDA) to Food and Drug Adminstration (FDA) in 2nd Half of 2018


Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions. 

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Last Updated on December 20, 2017 by Marie Benz MD FAAD