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



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:November 2013
End Date:October 2014

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A Phase 3b, Multicenter, Open-label Exploratory Trial to Evaluate the Efficacy, Safety, and Subject Satisfaction With Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy

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.


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.
We found this trial at
24
sites
Smyrna, Georgia 30080
1911
mi
from 91732
Smyrna, GA
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One Utah Avenue
Cherry Hill, New Jersey 08002
856-857-9500
2383
mi
from 91732
Cherry Hill, NJ
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Allentown, Pennsylvania 18104
2353
mi
from 91732
Allentown, PA
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Baltimore, Maryland 21208
2295
mi
from 91732
Baltimore, MD
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Boston, Massachusetts 02135
2578
mi
from 91732
Boston, MA
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1224
mi
from 91732
Dallas, TX
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1892
mi
from 91732
Dayton, OH
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Garden Grove, California 92845
20
mi
from 91732
Garden Grove, CA
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Indianapolis, Indiana 46260
1792
mi
from 91732
Indianapolis, IN
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Lafayette, Indiana
1757
mi
from 91732
Lafayette, IN
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Lincoln, Rhode Island 02865
2560
mi
from 91732
Lincoln, RI
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Memphis, Tennessee 38119
1586
mi
from 91732
Memphis, TN
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Oklahoma City, Oklahoma 73116
1162
mi
from 91732
Oklahoma City, OK
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2186
mi
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Orlando, FL
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829
mi
from 91732
Portland, OR
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Raleigh, North Carolina 27609
2218
mi
from 91732
Raleigh, NC
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Rochester Hills, Michigan 48307
1964
mi
from 91732
Rochester Hills, MI
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796
mi
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Salem, OR
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Spokane, Washington 99204
938
mi
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Spokane, WA
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St. Louis, Missouri 63118
1571
mi
from 91732
St. Louis, MO
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Staten Island, New York 10305
2429
mi
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Staten Island, NY
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Temecula, California 92591
63
mi
from 91732
Temecula, CA
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Weymouth, Massachusetts 02190
2585
mi
from 91732
Weymouth, MA
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Woodstock, Vermont 05091
2501
mi
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Woodstock, VT
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