Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric (7-17 Years) With Major Depressive Disorder



Status:Recruiting
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:7 - 17
Updated:4/6/2019
Start Date:July 6, 2018
End Date:October 21, 2021
Contact:Clinical Trials Registry Team
Email:IR‐CTRegistration@Allergan.com
Phone:877‐277‐8566

Use our guide to learn which trials are right for you!

A Double-blind, Placebo- and Active-controlled Evaluation of the Safety and Efficacy of Levomilnacipran ER in Pediatric Patients 7-17 Years With Major Depressive Disorder

The objective of this study is to evaluate the efficacy, safety, and tolerability of
levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major
depressive disorder (MDD)


Inclusion Criteria:

- Patients must meet Diagnostic and statistical manual of mental disorders fifth edition
(DSM-5) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders -
Present and Lifetime (K-SADS-PL)

- Patients must have a score ≥ 40 on the Children's Depression Rating Scale-Revised
(CDRS-R) at Visits 1 and 2

- Patients must have a Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits
1 and 2

- Patients must have a caregiver who can and is willing to consent to be responsible for
safety monitoring of the patient, provide information about the patient's condition,
oversee the administration of investigational product, and accompany the patient to
all study visits

- Female patients of childbearing potential who are sexually active must agree to use a
reliable method of contraception that will continue for the duration of the study and
within 30 days following the end of study participation.

- A sexually active male patient must agree to use contraception as detailed below
during the treatment period and for at least 30 days after the last dose of
investigational product.

Exclusion Criteria:

- DSM-5-based diagnosis of an axis I disorder other than MDD that is the primary focus
of treatment.

- Prior diagnosis of mental retardation or amnestic or other cognitive disorders based
on DSM-5 criteria

- Imminent risk of injuring self or others or causing damage to property as judged by
the Investigator

- Suicide risk as determined by meeting either of the following criteria:

- Any suicide attempt within the past year

- Significant risk at Visit 1 (Screening) or Visit 2 (Baseline), as judged by the
Investigator based on the psychiatric interview or information collected in the
Columbia-Suicide Severity Rating Scale (C-SSRS) treatment-Related Criteria

- History of allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran,
fluoxetine, or any other Selective serotonin reuptake inhibitors (SSRI) or Serotonin
and norepinephrine reuptake inhibitors (SNRI) or known hypersensitivity to the
investigational products' non-medicinal ingredients including gelatin and cellulose

- Patients requiring prohibited concomitant medication or herbal supplements that could
not be discontinued or switched to an allowable alternative medication and stabilized
for at least 2 weeks preceding Visit 2 (Baseline)

- Patients taking any psychoactive drug or psychoactive herbal remedy within 5
half-lives before Baseline (Visit 2), Patients who have ever been treated with a depot
antipsychotic must also be excluded

- Patients who have initiated or terminated psychotherapy or behavior therapy within1
month before Visit 1 (Screening), or who plan to initiate or change such therapies
during the course of the study Other Medical criteria

- A clinically significant disease state that, in the investigator's opinion, might
indicate that the patient is unsuitable for the study

- Any cardiovascular disease or condition that is clinically significant, unstable, or
decompensated.

- Hypo- or hyperthyroidism, unless stabilized on appropriate pharmacotherapy with no
change in dosage for at least 3 months before Visit 1 (Screening)

- Any condition that would be expected to affect drug absorption (eg, gastric bypass
surgery)

- History of seizure disorder (except simple childhood febrile seizures before age 5),
unexplained syncope or black-out episodes, stroke, significant head injury, tumor of
the central nervous system, or any other condition that predisposes the patient toward
a risk for seizure

- History of drug or alcohol abuse or dependence within the past year

- Pregnant, breastfeeding, and/or planning to become pregnant and/or breastfeed during
the study or within 30 days following the end of study participation

Other Criteria

- Patients who are unable to swallow capsules

- Treatment with any investigational product within 3 months (or at least 5 half-lives,
whichever is longer) of Visit 1. Treatment with any investigational product other than
those provided by AGN during study participation will be a protocol violation, and the
patient will be terminated from this study

- Employee or immediate relative of an employee of AGN, any of its affiliates or
partners, or of the study center Patients or patients whose parent/guardian/LAR and/or
caregivers are unable to speak and understand English (or their native language if
this can be accommodated by the site and is approved by the Sponsor) sufficiently to
understand the nature of the study, to provide informed assent/consent, or to allow
the completion of all study assessments

- Unable or unlikely to comply with the study protocol or are unsuitable for any other
reason, as judged by the Investigator
We found this trial at
46
sites
Libertyville, Illinois 60048
?
mi
from
Libertyville, IL
Click here to add this to my saved trials
707 North Broadway
Baltimore, Maryland 21205
443-923-9200
Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
2150 Peachford Road
Atlanta, Georgia 30338
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78759
?
mi
from
Austin, TX
Click here to add this to my saved trials
2026 Wirt Road
Bellaire, Texas 77401
?
mi
from
Bellaire, TX
Click here to add this to my saved trials
Bellevue, Washington 98007
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
Beverly Hills, California 90212
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clinton, Utah 84015
?
mi
from
Clinton, UT
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Corona, CA
Click here to add this to my saved trials
Creve Coeur, Missouri 63141
?
mi
from
Creve Coeur, MO
Click here to add this to my saved trials
12655 North Central Expressway
Dallas, Texas 75243
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Decatur, Georgia 30030
?
mi
from
Decatur, GA
Click here to add this to my saved trials
El Campo, Texas 77347
?
mi
from
El Campo, TX
Click here to add this to my saved trials
Frisco, Texas 75034
?
mi
from
Frisco, TX
Click here to add this to my saved trials
Glendale, California 91204
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Homestead, Florida 33035
?
mi
from
Homestead, FL
Click here to add this to my saved trials
19255 Park Row Drive
Houston, Texas 77084
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Joliet, Illinois 60435
?
mi
from
Joliet, IL
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33313
?
mi
from
Lauderdale Lakes, FL
Click here to add this to my saved trials
Lewisville, Texas 75057
?
mi
from
Lewisville, TX
Click here to add this to my saved trials
Little Rock, Arkansas 72211
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90804
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Mason, OH
Click here to add this to my saved trials
McKinney, Texas 75069
?
mi
from
McKinney, TX
Click here to add this to my saved trials
Meridian, Idaho 83642
?
mi
from
Meridian, ID
Click here to add this to my saved trials
Naperville, Illinois 60563
?
mi
from
Naperville, IL
Click here to add this to my saved trials
Oceanside, California 92056
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
1010 West Chapman Avenue
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Overland Park, Kansas 66211
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Plano, Texas 75093
?
mi
from
Plano, TX
Click here to add this to my saved trials
Rochester, New York 14618
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Rochester Hills, Michigan 48307
?
mi
from
Rochester Hills, MI
Click here to add this to my saved trials
Smyrna, Georgia 30080
?
mi
from
Smyrna, GA
Click here to add this to my saved trials
801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Stockbridge, Georgia 30281
?
mi
from
Stockbridge, GA
Click here to add this to my saved trials
?
mi
from
Tyrone, GA
Click here to add this to my saved trials
Washington, District of Columbia 20010
?
mi
from
Washington,
Click here to add this to my saved trials
Wildomar, California 92595
?
mi
from
Wildomar, CA
Click here to add this to my saved trials