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Dasotraline Adult ADHD Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02276209
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Sunovion

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

Condition or disease Intervention/treatment Phase
Adult Attention Deficit Hyperactivity Disorder Drug: Dasotraline Other: Placebo Phase 3

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 636 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : December 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dasotraline 4 mg
Dasotraline 4 mg once daily
Drug: Dasotraline
Dasotraline 4 mg once daily

Experimental: Dasotraline 6 mg
Dasotraline 6 mg once daily
Drug: Dasotraline
Dasotraline 6 mg once daily

Placebo Comparator: Placebo
Placebo once daily
Other: Placebo
Placebo once daily




Primary Outcome Measures :
  1. Change from baseline at Week 8 in ADHD symptoms measured by the ADHD Rating Scale Version IV (ADHD RS IV) with adult prompts total score. [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :
  1. Change from baseline in ADHD symptoms measured with the ADHD Rating Scale Version IV (ADHD RS IV) with adult prompts total score at Weeks 1, 2, 4, and 6. [ Time Frame: 8 Weeks ]
  2. Change from baseline in the inattentiveness and hyperactivity-impulsivity subscale scores of the ADHD Rating Scale Version IV (ADHD RS IV) with adult prompts at Weeks 1, 2, 4, 6, and 8. [ Time Frame: 8 Weeks ]
  3. Change from baseline in Clinical Global Impression - Severity scale (CGI S) scale at Weeks 1, 2, 4, 6, and 8. [ Time Frame: 8 Weeks ]
  4. Change from baseline in Sheehan Depression Scale (SDS) total score at Weeks 4 and 8. [ Time Frame: 8 Weeks ]
  5. Change from baseline in Sheehan Depression Scale (SDS) domain scores: work/school, family life, social life at Weeks 4 and 8. [ Time Frame: 8 Weeks ]
  6. Change from baseline in Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF A) Global Executive Composite score and Behavioral Regulation Index (BRI) and Metacognition Index (MI) at Weeks 4 and 8. [ Time Frame: 8 Weeks ]
  7. Change from baseline in ADHD Impact Module - Adult AIM A in global domain scores at Weeks 4 and 8. [ Time Frame: 8 Weeks ]
  8. Time sensitive ADHD Symptom Scale (TASS) total score and subscale scores (Inattention and Hyperactive impulsive) at Weeks 3, 5, and 7. [ Time Frame: 8 Weeks ]
  9. Change from baseline in Adult ADHD Self Report Scale (Version 1.1) (ASRS) total score and subscale scores (inattention, hyperactivity-impulsivity, executive function, emotional control, and impulsivity) at each week. [ Time Frame: 8 Weeks ]
  10. Adult ADHD Medication Smoothness of Effect Scale (AMSES) score at Weeks 2, 4, 6, and 8. [ Time Frame: 8 Weeks ]
  11. Change from baseline in Pittsburgh Sleep Quality Index (PSQI) global score and 7 component scores at Weeks 2, 4, and 8. [ Time Frame: 8 Weeks ]
  12. The incidence of overall AEs, serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations. [ Time Frame: 8 Weeks ]
  13. Clinical laboratory evaluations (serum chemistry). [ Time Frame: 8 Weeks ]
  14. Clinical laboratory evaluations ( lipid panel). [ Time Frame: 8 Weeks ]
  15. Clinical laboratory evaluations (thyroid function panel). [ Time Frame: 8 Weeks ]
  16. Clinical laboratory evaluations (hematology). [ Time Frame: 8 Weeks ]
  17. Clinical laboratory evaluations (urinalysis). [ Time Frame: 8 Weeks ]
  18. Clinical evaluations (vital signs). [ Time Frame: 8 Weeks ]
  19. Clinical evaluations (orthostatic effects). [ Time Frame: 8 Weeks ]
  20. Clinical evaluations (physical examinations). [ Time Frame: 8 Weeks ]
  21. Clinical evaluations (body weight). [ Time Frame: 8 Weeks ]
  22. Clinical evaluations (12 lead ECGs). [ Time Frame: 8 Weeks ]
  23. Frequency and severity of suicidal ideation and suicidal behavior as assessed by the C SSRS. [ Time Frame: 8 Weeks ]
  24. Drug Effects Questionnaire (DEQ) scores at Weeks 1, 2, 4, 6, and 8. [ Time Frame: 8 Weeks ]
  25. Symptoms of withdrawal by Physician Withdrawal Checklist (PWC) scores at Week 8, 9, and 10. [ Time Frame: 10 Weeks ]
  26. Symptoms of withdrawal by Study Medication Withdrawal Questionnaire (SMWQ) scores at Weeks 9 and 10. [ Time Frame: 10 Weeks ]
  27. Symptoms of withdrawal by Hamilton Anxiety Rating Scale (HAM A) scores at Weeks 8, 9, and 10. [ Time Frame: 10 Weeks ]
  28. Symptoms of withdrawal by Montgomery-Asberg Depression Rating Scale (MADRS) scores at Weeks 8, 9, and 10. [ Time Frame: 10 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276209


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Locations
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United States, Arizona
NoesisPharma,LLC
Phoenix, Arizona, United States, 85032
United States, Arkansas
Preferred Research Partners
Little Rock, Arkansas, United States, 72211
United States, California
Southern California Research LLC
Beverly Hills, California, United States, 90210
Pharmacology Research Institute
Encino, California, United States, 91316
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States, 92845
North County Clinical Research
Oceanside, California, United States, 92056
University ot California, San Francisco
San Francisco, California, United States, 94143
Elite Clinical Trials, Inc.
Wildomar, California, United States, 92595
United States, Colorado
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
ConnecticutClinicalResearch
Cromwell, Connecticut, United States, 06416
United States, Florida
CNS Clinical Research Group
Coral Springs, Florida, United States, 33067
Gulfcoast Clinical Research
Fort Myers, Florida, United States, 33912
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256
Florida Clinical Research Center, LLC
Maitland, Florida, United States, 32751
Miami Research Associates
Miami, Florida, United States, 33143
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32801
Meridien Research
Tampa, Florida, United States, 33606
United States, Georgia
The Institute for Advanced Medical Research
Alpharetta, Georgia, United States, 30005
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
iResearch Atlanta, LLC
Decatur, Georgia, United States, 30030
Northwest Behavioral Research Center
Roswell, Georgia, United States, 30076
Carman Research
Smyrna, Georgia, United States, 30080
United States, Illinois
Capstone Clinical Research, Inc.
Libertyville, Illinois, United States, 60048
United States, Indiana
Alpine Clinic
Lafayette, Indiana, United States, 47905
United States, Louisiana
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States, 70629
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States, 48302
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States, 48307
United States, Missouri
Saint Charles Psychiatric Associates/Midwest Research Group
Saint Charles, Missouri, United States, 63301
Midwest Research Group
Saint Charles, Missouri, United States, 63304
United States, Nebraska
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, United States, 68526
United States, New Jersey
Center for Emotional Fitness
Cherry Hill, New Jersey, United States, 08002
United States, New York
Village Clinical Research Inc.
New York, New York, United States, 10003
NYU School of Medicine
New York, New York, United States, 10016
Eastside Comprehensive Medical Center, LLC
New York, New York, United States, 10021
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
United States, North Carolina
Duke Child and Family Study Center
Durham, North Carolina, United States, 27705
Triangle Neuropsychiatry
Durham, North Carolina, United States, 27707
United States, Ohio
University of Cincinnati, Department of Psychiatry
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
Paradigm Research Professionals
Oklahoma City, Oklahoma, United States, 73118
United States, Oregon
SummitResearchNetwork
Portland, Oregon, United States, 97210
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, United States, 97214
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, United States, 97301
United States, Pennsylvania
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, United States, 19403
United States, South Carolina
Medical University of SC (MUSC)
Charleston, South Carolina, United States, 29425
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
FutureSearch Clinical Trials, LP
Austin, Texas, United States, 78731
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States, 75231
Pillar Clinical Research, LLC
Dallas, Texas, United States, 75243
Bayou City Research Corporation
Houston, Texas, United States, 77007
Clinical Trials of Texas, Inc
San Antonio, Texas, United States, 78229
Road Runner Research
San Antonio, Texas, United States, 78258
Family Psychiatry of the Woodlands
The Woodlands, Texas, United States, 77381-4546
United States, Vermont
Neuropsychiatric Associates
Woodstock, Vermont, United States, 05091
United States, Virginia
NeuroScience, Inc
Herndon, Virginia, United States, 20170
United States, Washington
Summit Research Network LLC
Seattle, Washington, United States, 98104
United States, Wisconsin
Dean Foundation for Health, Research and Education
Middleton, Wisconsin, United States, 53562
Sponsors and Collaborators
Sunovion
Investigators
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Study Director: SEP-289 Medical Director, MD Sunovion

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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT02276209     History of Changes
Other Study ID Numbers: SEP360-301
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms