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Adult Attention Deficit Hyperactivity Disorder

This study has been completed.
Information provided by (Responsible Party):
Sunovion Identifier:
First received: September 18, 2012
Last updated: April 14, 2014
Last verified: April 2014

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

Condition Intervention Phase
Adult Attention Deficit Hyperactivity Disorder
Drug: SEP-225289
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Sunovion:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in ADHD symptoms measured with the ADHD RS IV at Weeks 1, 2, 3, and 6. [ Time Frame: Weeks 1, 2, 3, 4, and 6 ] [ Designated as safety issue: No ]
  • Change from baseline in Clinical Global Impression - Severity of Illness scale (CGI S) at Weeks 1, 2, 3, 4, and 6. [ Time Frame: Weeks 1, 2, 3, 4, and 6 ] [ Designated as safety issue: No ]
  • Change from baseline in the inattentiveness and hyperactivity subscales of the ADHD RS IV at Weeks 1, 2, 3, 4, and 6 [ Time Frame: Weeks 1, 2, 3, 4, and 6 ] [ Designated as safety issue: No ]
  • The percentage of responders at Weeks 1, 2, 3, 4, and 6. A responder is defined as a subject with a ≥ 30% improvement in ADHD symptoms compared with baseline as measured by the ADHD RS IV. [ Time Frame: Weeks 1, 2, 3, 4, and 6 ] [ Designated as safety issue: No ]
  • Change from baseline in cognition as measured by the CDR Computerized Cognitive Assessment System at Weeks 2, 4, and 6. [ Time Frame: Weeks 2, 4, and 6 ] [ Designated as safety issue: No ]
  • Change from baseline in the WRAADDS as measured at Weeks 1, 2, 3, 4, and 6. [ Time Frame: Weeks 1, 2, 3, 4, and 6 ] [ Designated as safety issue: No ]

Enrollment: 341
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SEP-225289 4mg
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 4mg once daily
Drug: SEP-225289
SEP-225289 8mg once daily
Experimental: SEP-225289 8mg
SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
Drug: SEP-225289
SEP-225289 4mg once daily
Drug: SEP-225289
SEP-225289 8mg once daily
Placebo Comparator: Placebo
4 capsules of placebo
Drug: Placebo
Placebo once daily

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.


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01692782

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Sponsors and Collaborators
Study Director: CNS Medical Director, MD Sunovion
  More Information

No publications provided

Responsible Party: Sunovion Identifier: NCT01692782     History of Changes
Other Study ID Numbers: SEP360-201
Study First Received: September 18, 2012
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunovion:
Attention deficit hyperactivity disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms processed this record on November 25, 2014