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

NCT ID: NCT02012218

Last Updated: 2015-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-10-31

Brief Summary

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.

Conditions

Major Depressive Disorder (MDD)

Keywords

Major Depressive Disorder, Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADT and Brexpiprazole

ADT and Brexpiprazole

Group Type: EXPERIMENTAL

ADT

Intervention Type: DRUG

Brexpiprazole

Intervention Type: DRUG

Interventions

ADT

Intervention Type: DRUG

Brexpiprazole

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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:

1. Platelets ≤ 75,000/mm3

2. Hemoglobin ≤ 9 g/dL

3. Neutrophils, absolute ≤ 1000/mm3

4. AST > 2 × ULN

5. ALT > 2 × ULN

6. CPK > 3 × ULN, unless discussed with and approved by the medical monitor

7. Creatinine ≥ 2 mg/dL

8. HbA1c ≥ 7.0%

9. Abnormal free T4 (Note: Free T4 is measured only if result for TSH is abnormal.)

10. QTcF ≥ 470 msec for females and ≥ 450 msec for males

• Treatment with an MAOI or EMSAM within 14 days of the Baseline visit.
• Use of benzodiazepines and/or hypnotics within 7 days prior to the first dose of IMP
• Use of oral neuroleptics within 7 days prior or long-acting approved atypical antipsychotics ≤ 1 full cycle plus ½ cycle prior to the first dose of IMP
• Subjects who would be likely to require prohibited concomitant therapy during the trial.
• Subjects who previously participated in any prior brexpiprazole trial
• History of neuroleptic malignant syndrome or serotonin syndrome
• History of true allergic response to more than one 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.
• Any subject who, in the opinion of the investigator or medical monitor, should not participate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junichi Hashimoto, PhD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)

Locations

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

Countries

United States

References

Weiss C, Meehan SR, Brown TM, Gupta C, Morup MF, Thase ME, McIntyre RS, Ismail Z. Effects of adjunctive brexpiprazole on calmness and life engagement in major depressive disorder: post hoc analysis of patient-reported outcomes from clinical trial exit interviews. J Patient Rep Outcomes. 2021 Dec 11;5(1):128. doi: 10.1186/s41687-021-00380-4.

Reference Type: DERIVED

PMID: 34894307 (View on PubMed)

Fava M, Okame T, Matsushima Y, Perry P, Weiller E, Baker RA. Switching from Inadequate Adjunctive or Combination Treatment Options to Brexpiprazole Adjunctive to Antidepressant: An Open-Label Study on the Effects on Depressive Symptoms and Cognitive and Physical Functioning. Int J Neuropsychopharmacol. 2017 Jan 1;20(1):22-30. doi: 10.1093/ijnp/pyw087.

Reference Type: DERIVED

PMID: 27784751 (View on PubMed)

Other Identifiers

331-13-001

Identifier Type: -

Identifier Source: org_study_id