Adult Attention Deficit Hyperactivity Disorder - Full Text View

Purpose

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:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

U.S. FDA Resources

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 ]

Estimated Enrollment:	300
Study Start Date:	December 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 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.

Eligibility

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

Criteria

Inclusion Criteria:

Subject is 18 to 55 years old, inclusive, at the time of informed consent.
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 medications must be washed out during screening).
Subject has a negative urine drug screen (UDS) for any illicit drug or alcohol 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

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 a current diagnosis or diagnosis within the previous 12 months of bipolar disorder or any psychotic disorder, major depression, generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, or post-traumatic stress disorder as established by the Mini International Neuropsychiatric Interview (MINI).
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 prescription medication (eg, paroxetine, sertraline, venlafaxine, 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) or antipsychotic medication.
Subject is unwilling to refrain from taking medications that may interfere with the assessment of cognitive function.
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).
Subject has attempted suicide within 2 years prior to the screening period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692782

Contacts

Contact: Study Manager, MD

1-866-503-6351

Show 31 Study Locations

Sponsors and Collaborators

Sunovion

Investigators

Study Director:

CNS Medical Director, MD

Sunovion

More Information

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT01692782 History of Changes
Other Study ID Numbers:	SEP360-201
Study First Received:	September 18, 2012
Last Updated:	April 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

ADHD
Attention deficit hyperactivity disorder

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013