Dasotraline Adult ADHD Study



Status:Completed
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:7/21/2016
Start Date:December 2014
End Date:July 2016

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A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Efficacy and Safety Study of 2 Doses of Dasotraline in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating
the efficacy and safety of dasotraline in adults with ADHD.

This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating
the efficacy and safety of dasotraline in adults with ADHD using 2 doses of dasotraline (4
mg/day or 6 mg/day) versus placebo over an 8 week treatment period (8 weeks of active
treatment followed by a 2-week withdrawal phase).

Inclusion Criteria:

- Subject is male or female, 18 to 55 years old, inclusive, at the time of informed
consent.

- Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5) criteria
for a primary diagnosis of ADHD (inattentive, hyperactive, or combined subtype)
established by a comprehensive psychiatric evaluation that reviews psychiatric
criteria. Diagnosis is confirmed by Adult ADHD Clinical Diagnostic Scale (ACDS).
Note: The diagnosis of ADHD and appropriateness of inclusion in the trial will be
independently confirmed by external expert review. Experts will review diagnostic and
other screening instruments for each subject and approval is required before a
subject can be randomized. The Mini International Neuropsychiatric Interview (MINI)
will be administered to confirm the absence of any other comorbid psychiatric
disorders.

- Subject has an ADHD RS IV with adult prompts total score of ≥ 26 at screening and at
Baseline.

- Subject has a CGI S score of ≥ 4 at screening and at Baseline.

- Subject has a negative breath alcohol test and a negative urine drug screen (UDS) for
any illicit drug at screening.

- If the subject has a positive drug screen for ADHD medications (eg, amphetamine) at
screening, the subject must have a negative repeat UDS at least 7 days before
baseline.

- Subject is male or a non pregnant, non lactating female.

- Female subjects must have a negative serum pregnancy test at screening; females who
are post menopausal (defined as at least 12 months of spontaneous amenorrhea) and
those who have undergone hysterectomy or bilateral oophorectomy will be exempted from
the pregnancy test.

- Female subjects of childbearing potential and male subjects with female partners of
childbearing potential must agree to use an effective and medically acceptable form
of birth control, as defined in Section 10.4, throughout the study period. Note:
Continued use of an effective and medically acceptable form of birth control is
recommended for 30 days after study completion.

- Subject must have a stable living arrangement that allows for consistent
participation for the full duration of the study.

- Subject must be able to comply with study medication administration and adhere to
protocol requirements.

- Subject can read well enough to understand the informed consent form and other
subject materials.

- Subjects must complete a practice trial for the TASS assessment at one timepoint
during Screening.

Exclusion Criteria:

- Subject has a ≥ 25% improvement on the ADHD RS IV total score between screening and
baseline.

- Subject has a psychiatric disorder other than ADHD that has been the primary focus of
treatment at any time during the 12 months before screening.

- Subject has a past history of, or current presentation consistent with, bipolar
disorder (including bipolar I and bipolar II), schizophrenia, schizoaffective
disorder, or any other psychotic disorder; a personality disorder per DSM 5 criteria.

- Subject has a history of drug dependence or Substance Related Disorder (excluding
nicotine and caffeine) within the 12 months before screening, as defined by DSM 5
criteria.

-- Subject has Hamilton Anxiety Rating Scale (HAM A) total score ≥ 21 at screening
and baseline.

- Subject has PSQI total score ≥ 8 at screening or baseline or moderate to severe
insomnia as determined by the Investigator.

- Subject has a history of non-response (per clinician judgment) to two adequate
treatment regimens of stimulant or non-stimulant treatment for ADHD.

- Subject has a history of epilepsy, seizures (except childhood febrile seizures),
unexplained syncope or other unexplained blackouts (except single incident), or head
trauma with loss of consciousness lasting more than 5 minutes, or a history of
clinically significant multiple head traumas without loss of consciousness.

- Subject has an acute or chronic medical condition (other than ADHD) that in the
opinion of the investigator could confound clinical assessments or interfere with the
ability of the subject to participate in the study.

- Subject is currently taking or has taken within 6 weeks prior to screening an
antidepressent medication; antipsychotic medication; or lithium (any lithium
preparation or formulation).

- Subject is currently taking or has taken within the previous 6 months an
anticonvulsant medication (eg, phenytoin, carbamazepine, lamotrigine, valproic acid);
antipsychotic medication; or lithium (any lithium preparation or formulation).

- Subject is currently taking an alpha 2 adrenergic receptor agonist (including
clonidine and guanfacine).

- Subject has a life-time history of a pattern of abuse or diversion of stimulants.

- Subject has a body mass index (BMI) less than 18 or greater than 35 kg/m2 at
screening or baseline.

- Subject answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with
some intent to act, without specific plan) or item 5 (active suicidal ideation with
specific plan and intent) on the C SSRS assessment at screening (in the past month).
Subjects who answer "yes" to this question must be referred to the Investigator for
follow up evaluation.

- Subject has attempted suicide within 2 years before the screening period.

- Subject has history of positive test for Hepatitis B surface antigen or Hepatitis C
antibody and has liver function test results at screening above the upper limit of
normal (ULN) for the reference laboratory.

- Subject is known to have tested positive for human immunodeficiency virus (HIV).

- Subject has a clinically significant abnormality on screening evaluation including
physical examination, vital signs, ECG, or laboratory tests that the Investigator
considers to be inappropriate to allow participation in the study.

- The subject's screening ECG shows a corrected QT interval using Fridericia's formula
(QTcF) of ≥ 450 msec for male subjects or ≥ 470 msec for female subjects. Eligibility
will be based on the core laboratory ECG interpretation report.

- The subject's screening hematology results show an alanine aminotransferase (ALT) or
aspartate aminotransferase (AST) value ≥ 2 times the ULN, or a blood urea nitrogen
(BUN) value ≥ 1.5 times the ULN for the reference range.

- Subject has a history of allergic reaction or has a known or suspected sensitivity to
any substance that is contained in the study medication formulation.

- Subject is currently participating or has participated in a clinical trial within the
last 90 days or has participated in more than 2 clinical trials within the past year.
This includes studies using marketed compounds or devices. Note: Subjects will be
checked for multiple study enrollments by site staff.

- Subject has been incarcerated in a prison within 12 months prior to Screening.

- Subject has previously been randomized in a clinical trial of dasotraline.

- Subject is an investigational site staff member or the relative of an investigational
site staff member.
We found this trial at
59
sites
Little Rock, Arkansas 72211
Principal Investigator: Paul Wylie, MD
Phone: 501-553-9987
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707 North Broadway
Baltimore, Maryland 21205
443-923-9200
Principal Investigator: Robert Findling, MD
Phone: 410-614-3225
Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Thomas Spencer, MD
Phone: 617-724-5600
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One Utah Avenue
Cherry Hill, New Jersey 08002
856-857-9500
Principal Investigator: Leon Rosenberg, MD
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
Principal Investigator: Harry Croft, MD
Phone: 210-692-1222
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Alpharetta, Georgia 30005
Principal Investigator: Angelo Sambunaris, MD
Phone: 770-817-9200
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Principal Investigator: Robert Riesenberg, MD
Phone: 404-881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Austin, Texas 78756
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436 North Roxbury Drive
Beverly Hills, California 90210
Principal Investigator: Brock Summers, MD
Phone: 818-631-7189
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Bloomfield Hills, Michigan 48302
Principal Investigator: Richard Jackson, MD
Phone: 310-828-2966
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Charleston, South Carolina 29425
Principal Investigator: Kathleen Brady, MD
Phone: 843-792-5205
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Cincinnati, Ohio 45219
Principal Investigator: Caleb Adler, MD
Phone: 513-558-3362
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Colorado Springs, Colorado 80910
Principal Investigator: Andrew Sedillo, MD
Phone: 719-634-6576
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Coral Springs, Florida 33067
Principal Investigator: Ethan Kass, MD
Phone: 954-796-8222
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Cromwell, Connecticut 06416
Principal Investigator: Brendan Montano, MD
Phone: 860-632-0144
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Dallas, Texas 75243
Principal Investigator: Scott Bartley, MD
Phone: 214-396-4844
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Dallas, Texas 75231
Principal Investigator: Michael Downing, MD
Phone: 916-934-0569
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Decatur, Georgia 30030
Principal Investigator: Michael Burke, MD
Phone: 404-537-1281
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Durham, North Carolina 27705
Principal Investigator: Scott Kollins, MD
Phone: 919-681-0014
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Durham, North Carolina 27707
Principal Investigator: Mark Chandler, MD
Phone: 919-401-6212
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Encino, California 91316
Principal Investigator: Daniel Grosz, MD
Phone: 818-705-7451
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Fort Myers, Florida 33912
Principal Investigator: John Prater, MD
Phone: 239-561-0009
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Garden Grove, California 92845
Principal Investigator: David Walling, MD
Phone: 916-939-6696
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Herndon, Virginia 20170
Principal Investigator: Keith Saylor, MD
Phone: 703-787-9090
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Houston, Texas 77007
Principal Investigator: Matthew Brams, MD
Phone: 832-251-7000
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Jacksonville, Florida 32216
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Lafayette, Indiana
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Lake Charles, Louisiana 70601
Principal Investigator: Kashinath Yadalam, MD
Phone: 337-564-6405
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Libertyville, Illinois 60048
Principal Investigator: Michael Greenbaum, MD
Phone: 847-549-7214
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Lincoln, Nebraska 68510
Principal Investigator: Walter Duffy, MD
Phone: 402-817-2235
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Maitland, Florida 32751
Principal Investigator: Martin Kane, MD
Phone: 407-644-1165
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Miami, Florida
Principal Investigator: Americo Padilla, MD
Phone: 305-279-0015
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Middleton, Wisconsin 53562
Principal Investigator: Anne Koplin, MD
Phone: 608-827-2316
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Mt. Pleasant, South Carolina
Principal Investigator: Paul Robbins, MD
Phone: 843-856-3784
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New York, New York 10016
Principal Investigator: Lenard Adler, MD
Phone: 212-263-3580
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New York, New York 10021
Principal Investigator: Ram Shrivastava, MD
Phone: 212-288-0138
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New York, New York 10003
Principal Investigator: John Heussy, MD
Phone: 212-358-7071
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Norristown, Pennsylvania 19403
Principal Investigator: Cherian Verghese, MD
Phone: 610-295-3709
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Oceanside, California 92056
Principal Investigator: Valentin Isacescu, MD
Phone: 760-639-4378
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Oklahoma City, Oklahoma 73103
Principal Investigator: Louise Thurman, MD
Phone: 405-235-8188
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Oklahoma City, Oklahoma 73112
Principal Investigator: Jeffrey Seaman, MD
Phone: 405-268-2104
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Orlando, Florida 32806
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Phoenix, Arizona 85032
Principal Investigator: Lee Ann Kelley, MD
Phone: 602-795-1834
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Portland, Oregon 97210
Principal Investigator: Beal Essink, MD
Phone: 503-276-6224
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Portland, Oregon 97210
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Rochester, New York 14618
Principal Investigator: Sarah Atkinson, MD
Phone: 585-241-9670
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Rochester Hills, Michigan 48307
Principal Investigator: Joel Young, MD
Phone: 248-608-8800
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Roswell, Georgia 30076
Principal Investigator: Michael Banov, MD
Phone: 678-992-0109
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Salem, Oregon 97301
Principal Investigator: Alexander Horwitz, MD
Phone: 503-540-0100
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San Antonio, Texas 78258
Principal Investigator: Jerry Tomasovic, MD
Phone: 210-615-2333
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1600 Holloway Avenue
San Francisco, California 94143
Principal Investigator: R. Keith McBurnett, MD
Phone: 415-476-7892
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Seattle, Washington 98104
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Smyrna, Georgia 30080
Principal Investigator: John Carmen, MD
Phone: 770-333-0093
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St. Charles, Missouri 63301
Principal Investigator: Gregory Mattingly, MD
Phone: 636-946-8032
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St. Charles, Missouri 63301
Principal Investigator: John Canale, MD
Phone: 636-946-8032
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Tampa, Florida
Principal Investigator: Cynthia Huffman, MD
Phone: 813-877-8839
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The Woodlands, Texas 77381
Principal Investigator: Marshall Lucas, MD
Phone: 281-367-1015
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Wildomar, California 92595
Principal Investigator: Eliot Moon, MD
Phone: 951-678-1551
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Woodstock, Vermont 05091
Principal Investigator: Alicia Groft, MD
Phone: 802-457-4904
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