Investigating the Effect of Vortioxetine in Adult ADHD Patients

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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