Investigating the Effect of Vortioxetine in Adult ADHD Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

The purpose is to determine the effect of vortioxetine treatment on ADHD symptoms in adult patients with ADHD in a 12 weeks study.

Key facts

Study ID

NCT02327013

Run by

H. Lundbeck A/S

People needed

227

Starts

2014-12-01

Expected to finish

2016-09-01

Last updated by the study team

2018-03-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient is willing and able to attend study appointments within the specified time windows.
• The patient is an outpatient.
• The patient is diagnosed with a primary diagnosis of ADHD according to the DSM-5™ classification.
• The patient has an AISRS total score ≥24.
• The patient has a CGI-S rating ≥4 (moderately ill or worse).

You may not qualify if…

• The patient has previously been treated with vortioxetine.
• The patient has any current psychiatric disorder (DSM-IV-TR™ criteria), other than ADHD, as assessed using the Mini International Neuropsychiatric Interview (MINI).
• The patient has a known first-degree relative with bipolar disorder.
• The patient suffers from intellectual disability as evaluated by the Wechsler Abbreviated Scale of Intelligence (WASI) II vocabulary and matrix.
• The patient suffers from organic mental disorders, or mental disorders due to a general medical condition (DSM-5™ criteria).
• The patient has reported current use of, or has tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates, benzodiazepines, and cannabinoids). If a patient tests positive for opiates due to incidental use of codeine containing medication, as assessed in a clinical interview, the drug screen may be repeated up to three weeks later but the retest result must be available from the central laboratory latest at Visit 2 and has to be negative for this patient to be eligible for enrolment. If a patient tests positive for amphetamines due to his/her ADHD current treatment, as confirmed by a clinical interview, the patient is eligible for enrolment provided this treatment is discontinued two weeks prior to the Baseline Visit.
• The patient has a history of two prior failed (<50% improvement in symptoms) adequate trials of ADHD treatment.
• The patient has any other disorder for which the treatment takes priority over treatment of ADHD or is likely to interfere with study treatment or impair treatment compliance.
• The patient has a history of moderate or severe head trauma or other neurological disorders or systemic medical diseases that are, in the investigator's opinion, likely to affect central nervous system functioning.
• The patient has attempted suicide within the last 6 months or is at significant risk of suicide (either in the opinion of the Investigator or defined as a "yes" to suicidal ideation questions 4 or 5 or answering "yes" to suicidal behaviour on the Columbia-Suicide Rating Scale (C-SSRS) within the last 12 months).
• Other protocol defined inclusion and exclusion criteria do apply

Where it is running

• US015 — Beverly Hills, California, United States
• US002 — Garden Grove, California, United States
• US004 — National City, California, United States
• US013 — Bradenton, Florida, United States
• US006 — Gainesville, Florida, United States
• US010 — Alpharetta, Georgia, United States
• US014 — Libertyville, Illinois, United States
• US011 — Baltimore, Maryland, United States
• US009 — Boston, Massachusetts, United States
• US016 — Las Vegas, Nevada, United States
• US005 — New York, New York, United States
• US008 — New York, New York, United States
• US001 — Austin, Texas, United States
• US007 — Herndon, Virginia, United States
• US003 — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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