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

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01670279
First received: August 7, 2012
Last updated: November 6, 2013
Last verified: November 2013

August 7, 2012
November 6, 2013
July 2012
May 2013   (final data collection date for primary outcome measure)
  • Simpson-Angus Scale Total Score - Mean Change from baseline to study completion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Simpson-Angus Scale Total Score - Mean Change from baseline to study completion
  • Tolerability [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Brexpiprazole will be judged to be tolerated if 6 out of 8 (75%) subejcts in a test cohort tolerate the dose after 14 days of QD dosing at the end of the fixed dose phase based on the blinded data.
  • Number of Adverse Events [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    number of adverse evetns reported
  • Barnes Akathisia Global Score - Mean Change from baseline to study completion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Barnes Akathisia Global Score - Mean Change from baseline to study completion
  • AIMS Movement Rating Score - Mean Change from baseline to study completion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    AIMS Movement Rating Score - Mean Change from baseline to study completion
  • Columbia-Suicide Severity Rating Scale (C-SSRS) - Mean Change from Baseline to study completion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Columbia-Suicide Severity Rating Scale (C-SSRS) - Mean Change from Baseline to study completion
  • Laboratory Values of Potential Clinical Relevance - Mean Change from Baseline to study completion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Laboratory Values of Potential Clinical Relevance - Mean Change from Baseline to study completion
  • Vital Signs of Potential Clinical Relevance - Mean Change from Baseline to study completion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Vital Signs of Potential Clinical Relevance - Mean Change from Baseline to study completion
  • ECG Measurements of Potential Clinical Relevance - Mean Change from Baseline to study completion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    ECG Measurements of Potential Clinical Relevance - Mean Change from Baseline to study completion
Same as current
Complete list of historical versions of study NCT01670279 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive Disorder
A Phase 1, Multicenter, Randomized, Double-blind, Sequential Cohort, Placebo-controlled Trial to Assess the Safety and Tolerability of Ascending Multiple Oral Doses of Brexpiprazole as Adjunctive Therapy in the Treatment of Elderly Subjects With Major Depressive Disorder

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.

This is a phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose trial in 3 sequential cohorts of elderly subjects (age 70 to 85 years old) with MDD. Brexpiprazole will be administered as an adjunct treatment to the current antidepressant therapy that the subject is receiving. Total individual subject duration is expected to be no more than 119 days (a 30-day screening period, a 14-day washout period, up to 45-day in-clinic treatment period, and a 30-day follow-up after the last dose of trial medication).

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Brexpiprazole
    up to 3mg oral dose once daily
  • Drug: Placebo
  • Experimental: Cohort 1
    14 day titration phase and two fixed dose phases. The first fixed dose phase is 14 days with a daily dose of 2mg brexpiprazole/placebo. The second fixed dose phase is 14 days with a daily dose of 3 mg brexpiprazole/placebo.
    Intervention: Drug: Brexpiprazole
  • Experimental: Cohort 2
    14 day titration phase and a 14 day fixed dose phase a daily dose of 3mg brexpiprazole/placebo.
    Intervention: Drug: Brexpiprazole
  • Experimental: Cohort 3
    21 day titration phase and a 14 day fixed dose phase a daily dose of 3mg brexpiprazole/placebo.
    Intervention: Drug: Brexpiprazole
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    1. Platelets ≤ 75,000/mm3
    2. Hemoglobin ≤ 9 g/dL
    3. Neutrophils, absolute ≤ 1000/mm3
    4. AST > 3 × upper limit of normal
    5. ALT > 3 × upper limit of normal
    6. Creatinine ≥ 2 mg/dL
    7. HbA1c ≥ 7%
    8. QTcF ≥ 450 msec
  • Treatment with a MAOI within the 2 weeks prior to the first dose of trial medication
  • Use of benzodiazepines and/or hypnotics within 1 week prior the first dose of trial medication
  • Use of oral neuroleptics within 30 days prior to or long-acting approved neuroleptics ≤ 1 full cycle plus 14 days prior to the first dose of trial medication on Day 1
  • Prohibited concomitant medications used prior to randomization or anticipated need for such medications during the trial
  • Subjects who would be likely to require prohibited concomitant therapy during the trial
  • Subjects who received brexpiprazole in any prior clinical trial
  • Subjects with a history of neuroleptic malignant syndrome
  • Subjects with a history of true allergic response to more than 1 class of medications
  • Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
  • Subjects who participated in a clinical trial within the last 180 days or who participated in more than 2 clinical trials within the past year.
Both
70 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01670279
331-12-291
No
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S
Study Director: James M. Youakim, MD Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP