Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive Disorder

Completed · Phase 1 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The purpose of this study is to assess the safety and tolerability of ascending multiple oral doses of brexpiprazole as adjunctive therapy in the treatment of elderly subjects with MDD.

Key facts

Study ID

NCT01670279

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

18

Starts

2012-07-01

Expected to finish

2013-05-01

Last updated by the study team

2016-02-04

Who can join

Age: 70 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who are able to provide written informed consent
• Ability to understand the nature of the trial and follow protocol requirements
• Male and female patients 70 to 85 years of age
• Subjects with normal or clinically stable findings on physical examination, medical history, clinical laboratory determinations, ECGs in relation to age
• BMI of 18 to 35 kg/m2.
• Stable subjects with a principal psychiatric diagnosis of MDD
• Subjects willing to discontinue all prohibited psychotropic and other prohibited medication

You may not qualify if…

• Sexually active males who are not practicing 2 different methods of birth control during the trial and for 30 days after the last dose of trial medication or who will not remain abstinent during the trial and for 30 days after the last dose
• Subjects who have had a vagus nerve stimulation device implanted or who have received ECT within 6 months of Screening
• Subjects with a current Axis I (DSM-IV-TR) diagnosis of:
• Delirium, dementia, amnestic, or other cognitive disorder
• Eating disorder (including anorexia nervosa or bulimia)
• Obsessive-compulsive disorder
• Panic disorder
• Posttraumatic stress disorder or current or prior Axis I (DSM-IV-TR) diagnosis of Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder or bipolar disorder not otherwise specified
• Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
• Subjects experiencing hallucinations, delusions, or any psychotic symptomatology
• Subjects who have Active Suicidal Ideation with Some Intent to Act and whose most recent episode occurred within the last 6 months
• Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days
• Subjects with hypothyroidism or hyperthyroidism and/or an abnormal result for free T4 at Screening
• Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders
• Subjects with IDDM
• Subjects with uncontrolled hypertension (DBP > 95 mmHg) or symptomatic hypotension
• Subjects with epilepsy, a history of epilepsy, or a history of seizure
• Subjects with a positive drug screen for cocaine or other drugs of abuse
• The following laboratory test and ECG results are exclusionary:
• Platelets ≤ 75,000/mm3
• Hemoglobin ≤ 9 g/dL
• Neutrophils, absolute ≤ 1000/mm3
• AST > 3 × upper limit of normal
• ALT > 3 × upper limit of normal
• Creatinine ≥ 2 mg/dL

Where it is running

• Accurate Clinical Trials — Kissimmee, Florida, United States
• Miami Jewish Health System — Miami, Florida, United States
• St. Louis Clinical Trials — St Louis, Missouri, United States
• CRI Lifetree- Philadelphia Research Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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