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Adult Attention Deficit Hyperactivity DisorderPhase 2NCT01692782

Adult Attention Deficit Hyperactivity Disorder

A Phase 2 study testing SEP-225289 in people with Adult Attention Deficit Hyperactivity Disorder, run by Sumitomo Pharma America, Inc. at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A Phase 2 study of SEP-225289 in adults with attention deficit hyperactivity disorder (ADHD). Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
SEP-225289
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
341 participants
Where
31 sitesUnited States
Study dates
Dec 2012to Dec 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD (inattentive, hyperactive, or combined subtype) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria. Diagnosis is confirmed by Conners' Adult ADHD Diagnostic Interview (CAADID) Part 2.
  • Subject currently taking medication (stimulant or nonstimulant) for the control of ADHD symptoms has an ADHD RS-IV score of ≥ 22 at screening.
  • Subject currently not taking any medication for the purpose of controlling ADHD symptoms has an ADHD RS-IV score of ≥ 26 at screening.
  • Subject has a CGI-S score of ≥ 4 at screening.
  • Subject has a lifetime history of treatment with at least one medication for ADHD (stimulant or nonstimulant). Subjects may be either medicated or unmedicated for ADHD at the time of screening (all ADHD medications must be washed out during screening).
  • Subject has a negative breath alcohol test and a negative urine drug screen (UDS) for any illicit drug at screening, unless a false positive is suspected, in which case the UDS will be repeated. If the subject has a positive drug screen for ADHD medications (ie, methylphenidate or amphetamine) at screening; the subject must have a negative UDS after a washout period at least 3 days prior to baseline.
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  • Subject is male or a non-pregnant, non-lactating female.
  • Female subjects must have a negative serum pregnancy test at screening; women 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 child-bearing potential must agree to use an effective and medically acceptable form of birth control throughout the study period and for one month (30 days) after study completion. Medically acceptable and effective contraceptives include abstinence, prescription hormonal contraceptives (oral, patch, vaginal ring, implant, or injection), diaphragm with spermicide, intrauterine device (IUD), condom with spermicide, surgical sterilization, or vasectomy. For male subjects adequate contraception is defined as abstinence or continuous use of 2 barrier methods of contraception (eg, spermicidal condom).
  • Subject is 18 to 55 years old, inclusive, at the time of informed consent. 11. Subject can read well enough to understand the informed consent form and other subject materials.

Who cannot join

  • Subject has a DSM-IV-TR diagnosis of ADHD not otherwise specified.
  • Subject is receiving adequate benefit from current ADHD medication in the opinion of the investigator.
  • Subject has an Axis I disorder other than ADHD that has been the primary focus of treatment at any time during the 12 months prior to screening.
  • Subject has a past history of, or current presentation consistent with, bipolar disorder (including bipolar I, bipolar II, and bipolar not otherwise specified [NOS]), schizophrenia, schizoaffective disorder, or any other psychotic disorder.
  • Subject has a history of drug dependence or substance abuse (excluding nicotine and caffeine) within the 12 months prior to screening, as defined by the DSM-IV-TR criteria.
  • Subject has a current Axis II disorder per DSM-IV-TR criteria.
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  • 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.
  • Subject has a currently active medical condition (other than ADHD) that, in the opinion of the investigator, could interfere with the ability of the subject to participate in the study.
  • Subject is currently taking an antidepressant medication (eg, bupropion, selective serotonin reuptake inhibitor [SSRI]/ serotonin norepinephrine reuptake inhibitor [SNRI], monoamine oxidase [MAO] blocker, tricyclic, etc) or St. John's Wort.
  • Subject is currently taking or has taken within the previous 6 months an anticonvulsant medication (eg, phenytoin, carbamazepine, lamotrigine, valproic acid, etc); 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 Body Mass Index (BMI) less than 18 or greater than 35 kg/m2 (refer to Appendix V)
  • 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 prior to the screening period.
  • Subject has history of positive test for Hepatitis B surface antigen or Hepatitis C antibody. Note: Subjects with a history of a positive test for Hepatitis B surface antigen or Hepatitis C antibody may be enrolled in the study if they have liver function test results at screening within the normal range.
  • 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 in consultation with the medical monitor 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.
  • The subject's screening hematology results show an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value ≥ 2 times the upper limit of normal (ULN), or a blood urea nitrogen (BUN) value ≥ 1.5 times the ULN for the reference lab.
  • Subject who is currently participating or has participated in a clinical trial within the last 180 days or who participated in more than 2 clinical trials within the past year. This includes studies using marketed compounds or devices.
  • Subject is at high risk of non-compliance in the investigator's opinion.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • Future Search Clinical Trials, LP

    Austine, Texas, 78731

  • Florida Clinical Research Center, LLC

    Bradenton, Florida, 34201

  • Brooklyn Medical Institutes, LLC

    Brooklyn, New York, 11214

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002

  • Midwest Clinical Research Center

    Dayton, Ohio, 45408

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Duke Child and Family Study Center

    Durham, North Carolina, 27705

  • Pharmacology Research Institute

    Encino, California, 91316

  • Collaborative Neuroscience Network Inc

    Garden Grove, California, 92645

  • NeuroScience, Inc

    Herndon, Virginia, 20170

  • Goldpoint Clinical Research

    Indianapolis, Indiana, 46260

  • University of California at Irvine

    Irvine, California, 92612

  • Clinical Neuroscience Solutions Inc.

    Jacksonville, Florida, 32216

  • Eastside Therapeutic Resource

    Kirkland, Washington, 98033

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • Florida Research Center

    Maitland, Florida, 32751

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Clinical Neuroscience Solutions

    Memphis, Tennessee, 38119

  • Miami Research Associates

    Miami, Florida, 33143

  • Pharmacology Research Institute

    Newport Beach, California, 92660-2452

  • Research Centers of America, LLC

    Oakland Park, Florida, 33334

  • Excell Research, Inc

    Oceanside, California, 92056

  • IPS Research Company

    Oklahoma City, Indiana, 73103

  • CRI Lifetree

    Philadelphia, Pennsylvania, 19139

  • Oregon Center for Clinical Investigations, Inc.

    Portland, Oregon, 97210

  • Rochester Center for Behavioral Health

    Rochester Hills, Michigan, 48307

  • Midwest Research Group

    Saint Charles, Missouri, 63301

  • Medical Research Group of Central Florida

    Sanford, Florida, 32771

  • Neuropsychiatric Research Center of Orange County

    Santa Ana, California, 92701

  • Summit Research Network, LLC-Seattle

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Parallel Group, Multicenter Efficacy and Safety Study of SEP-225289 Versus Placebo in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

A Phase 2 study of SEP-225289 in adults with attention deficit hyperactivity disorder (ADHD).

Read the detailed description

This is a Phase 2, randomized, double-blind, parallel-group, multicenter, outpatient study evaluating the efficacy and safety of SEP 225289 in adults with ADHD using 2 oral dosages (4 or 8 mg SEP 225289 once daily [QD]) versus placebo over a 4 week treatment period.

Being tested
SEP-225289, Placebo
Keywords
ADHD, Attention deficit hyperactivity disorder
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.

  • SEP-225289Drug

    Also called Dasotraline

    SEP-225289 4mg once daily

  • SEP-225289Drug

    Also called Dasotraline

    SEP-225289 8mg once daily

  • PlaceboDrug

    Placebo once daily

Study groups in NCT01692782
Study groupRoleWhat they receive
SEP-225289 4mgExperimentalSEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
Receives: Drug: SEP-225289
SEP-225289 8mgExperimentalSEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
Receives: Drug: SEP-225289
PlaceboPlacebo comparator4 capsules of placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline at Week 4 in ADHD Symptoms Measured With the ADHD Rating Scale Version IV With Adult Prompts (ADHD RS IV)

    The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores.

    Measured: 4 Weeks

Secondary outcomes (5)

  1. Change From Baseline in ADHD Symptoms Measured With the ADHD RS IV at Weeks 1, 2, 3.

    The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores (range 0 - 54).

    Measured: Weeks 1, 2, 3

  2. Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI S) at Weeks 1, 2, 3, 4.

    The CGI-S modified asked the clinician one question: Considering your total clinical experience with adult ADHD, how mentally ill is the subject at this time?".The clinician's answer was rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = ng the most extremely ill subjects.

    Measured: Weeks 1, 2, 3, 4

  3. Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4

    The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The even number items (2, 4, 6, 8, 10, 12, 14, 16, 18) assess hyperactive impulsive symptoms and the odd number items (1, 3, 5, 7, 9, 11, 13, 15, 17) assess inattentive symptoms. The ADHD inattentiveness subscale score is defined as sum of items (1, 3, 5, 7, 9, 11, 13, 15, 17) scores (range 0 - 27). The ADHD hyperactive impulsive subscale score is defined as sum of items (2, 4, 6, 8, 10, 12, 14, 16, 18) scores (range 0 - 27).

    Measured: Weeks 1, 2, 3, 4

  4. The Number of Responders at Weeks 1, 2, 3, 4. A Responder is Defined as a Subject With a ≥ 30% Improvement in ADHD Symptoms Compared With Baseline as Measured by the ADHD RS IV.

    Measured: Weeks 1, 2, 3, 4

  5. Change From Baseline in the Wender-Reimher Adult Attention Deficit Disorder Scale (WRAADDS) as Measured at Weeks 1, 2, 3, 4.

    The WRAADDS measured the severity of the target symptoms of adults with ADHD. It measured symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rated individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) and summarized each of the 7 categories on a 0 to 4 scale (0 = none, 1 = mild, 2 = moderate, 3 = quite a bit, 4 = very much). The WRAADDS total score is defined as sum of all 28 item subscores (range 0 - 56).

    Measured: Weeks 1, 2, 3, 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionNov 2013
  4. Study completionDec 2013

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
341 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01692782
Sponsor's protocol ID
SEP360-201
Status last verified
Jan 2015
First submitted
18 Sep 2012
Last updated
12 Jan 2015
Data monitoring committee
Yes

Publications

  • Hopkins SC, Sunkaraneni S, Skende E, Hing J, Passarell JA, Loebel A, Koblan KS. Pharmacokinetics and Exposure-Response Relationships of Dasotraline in the Treatment of Attention-Deficit/Hyperactivity Disorder in Adults. Clin Drug Investig. 2016 Feb;36(2):137-46. doi: 10.1007/s40261-015-0358-7.

    PubMed 26597180

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SEP-225289 in people with Adult Attention Deficit Hyperactivity Disorder, run by Sumitomo Pharma America, Inc. at 31 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 10 inclusion and 21 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 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 4 in ADHD Symptoms Measured With the ADHD Rating Scale Version IV With Adult Prompts (ADHD RS IV) (time frame: 4 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 NCT01692782, which also lists 1 linked publication.

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 12 Jan 2015; AzTrials last refreshed its copy on 31 Oct 2026.

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