investigating the effect of vortioxetine in adult adhd patients

Conditions: Attention Deficit Hyperactivity Disorder

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

the study employed the sequential parallel comparison design (spcd), a clinical study design which intend to increase signal detection by using two stages of treatment: * stage 1 - first 6 weeks of the 12-weeks treatment period (visit 2/baseline 1 to visit 5/week 6) * stage 2 - last 6 weeks of the 12-weeks treatment period (visit 5/baseline 2 to visit 8/week 12) in stage 1, patients were randomized to placebo or vortioxetine 10 or 20mg. patients on vortioxetine 10 or 20mg/day during stage 1 remained on the same treatment in stage 2. responders to placebo in stage 1 remained on placebo in stage 2. patients who were placebo non-responders during stage 1, defined as patients with a \<30% reduction in aisrs total score from baseline 1, were re-randomized to placebo or vortioxetine 10 or 20mg/day in stage 2.

Eligibility 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