Adult Attention Deficit Hyperactivity DisorderPhase 3NCT02276209
Dasotraline Adult ADHD Study
A Phase 3 study testing Dasotraline in people with Adult Attention Deficit Hyperactivity Disorder, run by Sumitomo Pharma America, Inc. at 59 sites in United States.
Trial summary
This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in adults with ADHD. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Adult Attention Deficit Hyperactivity Disorder
- What is being tested?
- Dasotraline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 636 participants
- Where
- 59 sitesUnited States
- Study dates
- Dec 2014to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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.
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
United States59 sites
The Institute for Advanced Medical Research
Alpharetta, Georgia, 30005
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
FutureSearch Clinical Trials, LP
Austin, Texas, 78731
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Southern California Research LLC
Beverly Hills, California, 90210
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of SC (MUSC)
Charleston, South Carolina, 29425
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
University of Cincinnati, Department of Psychiatry
Cincinnati, Ohio, 45219
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910
CNS Clinical Research Group
Coral Springs, Florida, 33067
ConnecticutClinicalResearch
Cromwell, Connecticut, 06416
FutureSearch Trials of Dallas, LP
Dallas, Texas, 75231
Pillar Clinical Research, LLC
Dallas, Texas, 75243
iResearch Atlanta, LLC
Decatur, Georgia, 30030
Duke Child and Family Study Center
Durham, North Carolina, 27705
Triangle Neuropsychiatry
Durham, North Carolina, 27707
Pharmacology Research Institute
Encino, California, 91316
Gulfcoast Clinical Research
Fort Myers, Florida, 33912
Collaborative Neuroscience Network, LLC
Garden Grove, California, 92845
NeuroScience, Inc
Herndon, Virginia, 20170
Bayou City Research Corporation
Houston, Texas, 77007
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Alpine Clinic
Lafayette, Indiana, 47905
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629
Capstone Clinical Research, Inc.
Libertyville, Illinois, 60048
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68526
Preferred Research Partners
Little Rock, Arkansas, 72211
Florida Clinical Research Center, LLC
Maitland, Florida, 32751
Miami Research Associates
Miami, Florida, 33143
Dean Foundation for Health, Research and Education
Middleton, Wisconsin, 53562
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Village Clinical Research Inc.
New York, New York, 10003
NYU School of Medicine
New York, New York, 10016
Eastside Comprehensive Medical Center, LLC
New York, New York, 10021
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19403
North County Clinical Research
Oceanside, California, 92056
IPS Research Company
Oklahoma City, Oklahoma, 73103
Paradigm Research Professionals
Oklahoma City, Oklahoma, 73118
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
NoesisPharma,LLC
Phoenix, Arizona, 85032
SummitResearchNetwork
Portland, Oregon, 97210
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97214
Finger Lakes Clinical Research
Rochester, New York, 14618
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
Northwest Behavioral Research Center
Roswell, Georgia, 30076
Saint Charles Psychiatric Associates/Midwest Research Group
Saint Charles, Missouri, 63301
Midwest Research Group
Saint Charles, Missouri, 63304
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301
Clinical Trials of Texas, Inc
San Antonio, Texas, 78229
Road Runner Research
San Antonio, Texas, 78258
University ot California, San Francisco
San Francisco, California, 94143
Summit Research Network LLC
Seattle, Washington, 98104
Carman Research
Smyrna, Georgia, 30080
Meridien Research
Tampa, Florida, 33606
Family Psychiatry of the Woodlands
The Woodlands, Texas, 77381-4546
Elite Clinical Trials, Inc.
Wildomar, California, 92595
Neuropsychiatric Associates
Woodstock, Vermont, 05091
About this study
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)
This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in adults with ADHD.
Read the 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).
- Being tested
- Dasotraline, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasotralineDrug
Dasotraline 4 mg once daily
DasotralineDrug
Dasotraline 6 mg once daily
PlaceboOther
Placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| Dasotraline 4 mg | Experimental | Dasotraline 4 mg once daily Receives: Drug: Dasotraline |
| Dasotraline 6 mg | Experimental | Dasotraline 6 mg once daily Receives: Drug: Dasotraline |
| Placebo | Placebo comparator | Placebo once daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Weeks
Secondary outcomes (28)
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.
Measured: 8 Weeks
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.
Measured: 8 Weeks
Change from baseline in Clinical Global Impression - Severity scale (CGI S) scale at Weeks 1, 2, 4, 6, and 8.
Measured: 8 Weeks
Change from baseline in Sheehan Depression Scale (SDS) total score at Weeks 4 and 8.
Measured: 8 Weeks
Change from baseline in Sheehan Depression Scale (SDS) domain scores: work/school, family life, social life at Weeks 4 and 8.
Measured: 8 Weeks
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.
Measured: 8 Weeks
Change from baseline in ADHD Impact Module - Adult AIM A in global domain scores at Weeks 4 and 8.
Measured: 8 Weeks
Time sensitive ADHD Symptom Scale (TASS) total score and subscale scores (Inattention and Hyperactive impulsive) at Weeks 3, 5, and 7.
Measured: 8 Weeks
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.
Measured: 8 Weeks
Adult ADHD Medication Smoothness of Effect Scale (AMSES) score at Weeks 2, 4, 6, and 8.
Measured: 8 Weeks
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) global score and 7 component scores at Weeks 2, 4, and 8.
Measured: 8 Weeks
The incidence of overall AEs, serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations.
Measured: 8 Weeks
Clinical laboratory evaluations (serum chemistry).
Measured: 8 Weeks
Clinical laboratory evaluations ( lipid panel).
Measured: 8 Weeks
Clinical laboratory evaluations (thyroid function panel).
Measured: 8 Weeks
Clinical laboratory evaluations (hematology).
Measured: 8 Weeks
Clinical laboratory evaluations (urinalysis).
Measured: 8 Weeks
Clinical evaluations (vital signs).
Measured: 8 Weeks
Clinical evaluations (orthostatic effects).
Measured: 8 Weeks
Clinical evaluations (physical examinations).
Measured: 8 Weeks
Clinical evaluations (body weight).
Measured: 8 Weeks
Clinical evaluations (12 lead ECGs).
Measured: 8 Weeks
Frequency and severity of suicidal ideation and suicidal behavior as assessed by the C SSRS.
Measured: 8 Weeks
Drug Effects Questionnaire (DEQ) scores at Weeks 1, 2, 4, 6, and 8.
Measured: 8 Weeks
Symptoms of withdrawal by Physician Withdrawal Checklist (PWC) scores at Week 8, 9, and 10.
Measured: 10 Weeks
Symptoms of withdrawal by Study Medication Withdrawal Questionnaire (SMWQ) scores at Weeks 9 and 10.
Measured: 10 Weeks
Symptoms of withdrawal by Hamilton Anxiety Rating Scale (HAM A) scores at Weeks 8, 9, and 10.
Measured: 10 Weeks
Symptoms of withdrawal by Montgomery-Asberg Depression Rating Scale (MADRS) scores at Weeks 8, 9, and 10.
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adult Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 636 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SEP-289 Medical Director, MD, Study director, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276209
- Sponsor's protocol ID
- SEP360-301
- Status last verified
- Aug 2017
- First submitted
- 21 Oct 2014
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gumenyuk S, Ogirala A, Szabo ST, Koblan K, Hopkins SC, Ufer M. Characterization of the Safety Profile of the Triple Monoamine Reuptake Inhibitor Dasotraline Based on Clinical Trial Data and Disproportionality Analyses of Four Related Pharmacological Classes Using Real-World Data from the FDA Adverse Event Reporting System. Clin Drug Investig. 2026 Apr;46(4):455-465. doi: 10.1007/s40261-026-01525-3. Epub 2026 Feb 16.
PubMed 41697570Adler LA, Goldman R, Hopkins SC, Koblan KS, Kent J, Hsu J, Loebel A. Dasotraline in adults with attention deficit hyperactivity disorder: a placebo-controlled, fixed-dose trial. Int Clin Psychopharmacol. 2021 May 1;36(3):117-125. doi: 10.1097/YIC.0000000000000333.
PubMed 33724251
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02276209
- Acronym / sponsor ID
- SEP360-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 636 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double blind, multicenter, parallel group, outpatient study evaluating the efficacy and safety of dasotraline in adults with ADHD.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dasotraline 4 mg | Experimental | Drug: DasotralineDasotraline 4 mg once daily |
| Dasotraline 6 mg | Experimental | Drug: DasotralineDasotraline 6 mg once daily |
| Placebo | Placebo comparator | Other: PlaceboPlacebo once daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasotralineDasotraline 4 mg once daily | Drug | Dasotraline 4 mg |
| DasotralineDasotraline 6 mg once daily | Drug | Dasotraline 6 mg |
| PlaceboPlacebo once daily | Other | Placebo |
Primary outcome
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
28 secondary outcomes
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
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
Change from baseline in Clinical Global Impression - Severity scale (CGI S) scale at Weeks 1, 2, 4, 6, and 8.
Time frame: 8 Weeks
Change from baseline in Sheehan Depression Scale (SDS) total score at Weeks 4 and 8.
Time frame: 8 Weeks
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
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
Change from baseline in ADHD Impact Module - Adult AIM A in global domain scores at Weeks 4 and 8.
Time frame: 8 Weeks
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
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
Adult ADHD Medication Smoothness of Effect Scale (AMSES) score at Weeks 2, 4, 6, and 8.
Time frame: 8 Weeks
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
The incidence of overall AEs, serious AEs (SAEs), and AEs (or SAEs) leading to discontinuations.
Time frame: 8 Weeks
Clinical laboratory evaluations (serum chemistry).
Time frame: 8 Weeks
Clinical laboratory evaluations ( lipid panel).
Time frame: 8 Weeks
Clinical laboratory evaluations (thyroid function panel).
Time frame: 8 Weeks
Clinical laboratory evaluations (hematology).
Time frame: 8 Weeks
Clinical laboratory evaluations (urinalysis).
Time frame: 8 Weeks
Clinical evaluations (vital signs).
Time frame: 8 Weeks
Clinical evaluations (orthostatic effects).
Time frame: 8 Weeks
Clinical evaluations (physical examinations).
Time frame: 8 Weeks
Clinical evaluations (body weight).
Time frame: 8 Weeks
Clinical evaluations (12 lead ECGs).
Time frame: 8 Weeks
Frequency and severity of suicidal ideation and suicidal behavior as assessed by the C SSRS.
Time frame: 8 Weeks
Drug Effects Questionnaire (DEQ) scores at Weeks 1, 2, 4, 6, and 8.
Time frame: 8 Weeks
Symptoms of withdrawal by Physician Withdrawal Checklist (PWC) scores at Week 8, 9, and 10.
Time frame: 10 Weeks
Symptoms of withdrawal by Study Medication Withdrawal Questionnaire (SMWQ) scores at Weeks 9 and 10.
Time frame: 10 Weeks
Symptoms of withdrawal by Hamilton Anxiety Rating Scale (HAM A) scores at Weeks 8, 9, and 10.
Time frame: 10 Weeks
Symptoms of withdrawal by Montgomery-Asberg Depression Rating Scale (MADRS) scores at Weeks 8, 9, and 10.
Time frame: 10 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Derived from this study: PubMed 41697570Gumenyuk S, Ogirala A, Szabo ST, Koblan K, Hopkins SC, Ufer M. Characterization of the Safety Profile of the Triple Monoamine Reuptake Inhibitor Dasotraline Based on Clinical Trial Data and Disproportionality Analyses of Four Related Pharmacological Classes Using Real-World Data from the FDA Adverse Event Reporting System. Clin Drug Investig. 2026 Apr;46(4):455-465. doi: 10.1007/s40261-026-01525-3. Epub 2026 Feb 16.
- Derived from this study: PubMed 33724251Adler LA, Goldman R, Hopkins SC, Koblan KS, Kent J, Hsu J, Loebel A. Dasotraline in adults with attention deficit hyperactivity disorder: a placebo-controlled, fixed-dose trial. Int Clin Psychopharmacol. 2021 May 1;36(3):117-125. doi: 10.1097/YIC.0000000000000333.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEP-289 Medical Director, MD study director
Sumitomo Pharma America, Inc.
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dasotraline in people with Adult Attention Deficit Hyperactivity Disorder, run by Sumitomo Pharma America, Inc. at 59 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02276209, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.