Adult Attention Deficit Hyperactivity Disorder

NCT01692782 | Completed Phase 2 Results DMC

• 1 other identifier: SEP360-201
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 31

Brief Summary

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

Conditions

Adult Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Attention deficit hyperactivity disorder

Outcome Measures

Primary Outcomes (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.

  4 Weeks

Secondary Outcomes (5)

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

  Weeks 1, 2, 3

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

  Weeks 1, 2, 3, 4

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

  Weeks 1, 2, 3, 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.

  Weeks 1, 2, 3, 4

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

  Weeks 1, 2, 3, 4

Study Arms (3)

SEP-225289 4mg

EXPERIMENTAL

SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses

Drug: SEP-225289

SEP-225289 8mg

EXPERIMENTAL

SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses

Drug: SEP-225289

Placebo

PLACEBO COMPARATOR

4 capsules of placebo

Drug: Placebo

Interventions

SEP-225289 DRUG

SEP-225289 4mg once daily

Also known as: Dasotraline

SEP-225289 4mg

Placebo DRUG

Placebo once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (31)

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Collaborative Neuroscience Network Inc

Garden Grove, California, 92645, United States

Location

University of California at Irvine

Irvine, California, 92612, United States

Location

Pharmacology Research Institute

Los Alamitos, California, 90720, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660-2452, United States

Location

Excell Research, Inc

Oceanside, California, 92056, United States

Location

Neuropsychiatric Research Center of Orange County

Santa Ana, California, 92701, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 34201, United States

Location

Clinical Neuroscience Solutions Inc.

Jacksonville, Florida, 32216, United States

Location

Florida Research Center

Maitland, Florida, 32751, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Research Centers of America, LLC

Oakland Park, Florida, 33334, United States

Location

Medical Research Group of Central Florida

Sanford, Florida, 32771, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

Goldpoint Clinical Research

Indianapolis, Indiana, 46260, United States

Location

IPS Research Company

Oklahoma City, Indiana, 73103, United States

Location

Rochester Center for Behavioral Health

Rochester Hills, Michigan, 48307, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63301, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Brooklyn Medical Institutes, LLC

Brooklyn, New York, 11214, United States

Location

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45408, United States

Location

Oregon Center for Clinical Investigations, Inc.

Portland, Oregon, 97210, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

CRI Lifetree

Philadelphia, Pennsylvania, 19139, United States

Location

Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States

Location

Future Search Clinical Trials, LP

Austine, Texas, 78731, United States

Location

NeuroScience, Inc

Herndon, Virginia, 20170, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, 98033, United States

Location

Summit Research Network, LLC-Seattle

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 26597180 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

SEP 225289; 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: 1-866-503-6351
• Organization: Sunovion

clinicaltrialdisclosure@sunvion.com

1-866-503-6351

Study Officials

• CNS Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: September 25, 2012
• Study Start: December 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 12, 2015
• Results First Posted: January 12, 2015

Record last verified: 2015-01

Locations

US (31)