Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy

Completed · Phase 3

Conditions studied: Major Depressive Disorder (MDD)

In brief

The objectives of this exploratory trial are to evaluate the efficacy, safety, and subjects' subjective satisfaction when switching to adjunctive brexpiprazole in subjects with MDD who have responded inadequately to preceding adjunctive drug therapy.

Key facts

Study ID

NCT02012218

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

61

Starts

2013-11-01

Expected to finish

2014-10-01

Last updated by the study team

2015-12-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of MDD
• In current major depressive episode of ≥ 8 weeks in duration and includes an inadequate response to at least 1 adjunctive treatment.
• Positive history of at least 1 additional failure to an adequate monotherapy antidepressant treatment.
• HAM-D17 total score≥ 18
• Currently receiving SSRI of SNRI with adjunctive treatment for at least 6 weeks before screening.
• Willing to discontinue use of all prohibited psychotropic medications
• Historical positive serological results for HIV, hepatitis B/C
• Able to provide written informed consent prior to the initiation of any protocol-required procedures
• Subjects who could potentially benefit from adjunctive treatment with Brexpiprazole

You may not qualify if…

• Sexually active women of childbearing potential
• Male subjects not practicing 2 different methods of birth control
• Females who are breastfeeding and/or who have a positive pregnancy test result
• Subjects who have received ECT for the current major depressive episode.
• Subjects who have had an inadequate response to ECT
• Current need for involuntary commitment or who have been hospitalized within 4 weeks of screening
• Current Axis I (DSM-IV-TR)
• Current Axis II (DSM-IV-TR)
• Subjects experiencing hallucinations, delusions, or any psychotic symptomatology in the current major depressive episode.
• Subjects receiving new onset psychotherapy.
• Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 4, Item 5, or on any of the 5 C-SSRS Suicidal Behavior Items
• Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days
• Hypothyroidism or hyperthyroidism
• Clinically significant neurological, hepatic, renal, metabolic, haematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders
• Currently treated with insulin for diabetes
• Uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension
• Known ischemic heart disease or history of myocardial infarction, congestive heart failure, angioplasty, stenting, or coronary artery bypass surgery
• Epilepsy or history of seizures
• Positive drug screen
• The following laboratory test and ECG results are exclusionary:
• Platelets ≤ 75,000/mm3
• Hemoglobin ≤ 9 g/dL
• Neutrophils, absolute ≤ 1000/mm3
• AST > 2 × ULN
• ALT > 2 × ULN

Where it is running

• Collaborative NeuroScience Network, Inc. — Garden Grove, California, United States
• Viking Clinical Research, Ltd. — Temecula, California, United States
• Clinical Neuroscience Solutions Pharmacology — Orlando, Florida, United States
• Carman Research — Smyrna, Georgia, United States
• Goldpoint Clinical Research — Indianapolis, Indiana, United States
• Alpine Clinic — Lafayette, Indiana, United States
• Pharmasite Research — Baltimore, Maryland, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• Coastal Research Associates, Inc. — Weymouth, Massachusetts, United States
• Rochester Center for Behavioral Medicine — Rochester Hills, Michigan, United States
• St. Louis Clinical Trials — St Louis, Missouri, United States
• Center for Emotional Fitness — Cherry Hill, New Jersey, United States
• Behavioral Medical Research of Staten Island — Staten Island, New York, United States
• Richard H. Weisler, MD, PA — Raleigh, North Carolina, United States
• Midwest Clinical Research Center MCRC — Dayton, Ohio, United States
• Cutting Edge Research Group — Oklahoma City, Oklahoma, United States
• Oregon Center for Clinical Investigations, Inc. — Portland, Oregon, United States
• Oregon Center for Clinical Investigations, Inc. — Salem, Oregon, United States
• Lehigh Center for Clinical Research — Allentown, Pennsylvania, United States
• Lincoln Research, LLC — Lincoln, Rhode Island, United States
• Research Strategies of Memphis, LLC — Memphis, Tennessee, United States
• Future Search Trials of Dallas, LP — Dallas, Texas, United States
• NeuropsychiatricAssociates — Woodstock, Vermont, United States
• Frontier Institute — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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