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Dasotraline Adult ADHD Study | Clinical Trials | Clareo Health

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Dasotraline Adult ADHD Study

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)

NCT02276209•Sumitomo Pharma America, Inc.

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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.
+3 more criteria

Exclusion Criteria

•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.
•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).
+16 more criteria

Locations (59)

NoesisPharma,LLC

Phoenix, Arizona, United States

Preferred Research Partners

Little Rock, Arkansas, United States

Southern California Research LLC

Beverly Hills, California, United States

Pharmacology Research Institute

Encino, California, United States

Collaborative Neuroscience Network, LLC

Garden Grove, California, United States

North County Clinical Research

Oceanside, California, United States

University ot California, San Francisco

San Francisco, California, United States

Elite Clinical Trials, Inc.

Wildomar, California, United States

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, United States

ConnecticutClinicalResearch

Cromwell, Connecticut, United States

Key Dates

Start Date

December 1, 2014

Primary Completion Date

September 1, 2016

Completion Date

September 1, 2016

Last Updated

August 28, 2017

Enrollment

636

ACTUAL participants

Conditions

Adult Attention Deficit Hyperactivity Disorder

Interventions

Dasotraline

DRUG

Dasotraline

DRUG

Placebo

OTHER

The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder

NCT03324581

Adult Attention Deficit Hyperactivity Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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