Overview

This trial has been completed.

Condition attention deficit hyperactivity disorder
Treatments vortioxetine 10 mg tablet, vortioxetine 20 mg tablet, placebo tablet
Phase phase 2
Sponsor H. Lundbeck A/S
Start date December 2014
End date September 2016
Trial size 227 participants
Trial identifier NCT02327013, 15996A

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
vortioxetine 10 mg tablet Brintellix®
Oral tablets, once daily
(Experimental)
vortioxetine 20 mg tablet Brintellix®
Oral tablets, once daily
(Placebo Comparator)
placebo tablet
Oral tablets, once daily

Primary Outcomes

Measure
Change in ADHD Investigator Symptom Rating Scale (AISRS) total score
time frame: Baseline to Week 6

Secondary Outcomes

Measure
Inattention/Meta-cognition: Change in Behavior Rating Inventory of Executive Function - Adult version (BRIEF-A) using Metacognition Index
time frame: Baseline to Week 6
Cognitive Function/Global executive function: Change in BRIEF-A using the Global Executive Composite
time frame: Baseline to Week 6
Overall functioning: Change in Sheehan Disability Scale (SDS) total score
time frame: Baseline to Week 6
Productivity: Change in Work Limitation Questionnaire (WLQ) using the Productivity Loss score
time frame: Baseline to Week 6
Change in AISRS inattention sub-score
time frame: Baseline to Week 6
Change AISRS hyperactivity/impulsivity sub-score
time frame: Baseline to Week 6
Change in AISRS individual item scores
time frame: Baseline to Week 6
Response (defined as 30% or greater reduction from baseline in AISRS total score)
time frame: Baseline to Week 6
Change in Adult ADHD Self-Report Scale (ASRS) total score
time frame: Baseline to Week 6
Change in Clinical Global Impression - Severity of Illness (CGI-S) score
time frame: Baseline to Week 6
Clinical Global Impression - Global Improvement (CGI-I) score
time frame: Week 6
Response (defined as a CGI-I score of 1 or 2)
time frame: Week 6
Change in BRIEF-A using the Behavioural Regulation Index
time frame: Baseline to Week 6
Change in BRIEF-A subscales - Inhibit
time frame: Baseline to Week 6
Change BRIEF-A subscales - Initiate
time frame: Baseline to Week 6
Change in BRIEF-A subscales - Organization of Materials
time frame: Baseline to Week 6
Change in BRIEF-A subscales - Planning/Organize
time frame: Baseline to Week 6
Change in BRIEF-A subscales - Shift
time frame: Baseline to Week 6
Change in BRIEF-A subscales - Self Monitor
time frame: Baseline to Week 6
Change in BRIEF-A subscales - Task Monitor
time frame: Baseline to Week 6
Change in BRIEF-A subscales - Working Memory
time frame: Baseline to Week 6
Change in BRIEF-A subscales - Emotional Control
time frame: Baseline to Week 6
Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score
time frame: Baseline to Week 6
Change in PDQ-D subscales - Attention and concentration sub-score
time frame: Baseline to Week 6
Change in PDQ-D sub-scales - Retrospective memory sub-score
time frame: Baseline to Week 6
Change in PDQ-D sub-scales - Prospective memory sub-score
time frame: Baseline to Week 6
Change in PDQ-D sub-scales - Planning and organisation sub-score
time frame: Baseline to Week 6
Change in SDS item scores - family
time frame: Baseline to Week 6
Change in SDS item scores - work
time frame: Baseline to Week 6
Change in SDS item scores - social life
time frame: Baseline to Week 6
Change in SDS item scores - number of days lost
time frame: Baseline to Week 6
Change in SDS item scores - number of underproductive days
time frame: Baseline to Week 6
Change in WLQ using the Global Productivity Index
time frame: Baseline to Week 6
Change in WLQ Domain scores - Limitations Handling Time
time frame: Baseline to Week 6
Change in WLQ Domain scores - Mental-Interpersonal Work Demands
time frame: Baseline to Week 6
Change in WLQ Domain scores - Physical Demands
time frame: Baseline to Week 6
Change in WLQ Domain scores - Output Demands
time frame: Baseline to Week 6
Change in Adult ADHD Quality of Life Measure (AAQoL) score
time frame: Baseline to Week 6
Change in AAQoL subscales - Life productivity sub-score
time frame: Baseline to Week 6
Change in AAQoL subscales - Psychological Health sub-score
time frame: Baseline to Week 6
Change in AAQoL subscales - Life Outlook sub-score
time frame: Baseline to Week 6
Change in AAQoL subscales - Relationships sub-score
time frame: Baseline to Week 6

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - The patient is aged ≥18 years and ≤55 years. - 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

Additional Information

Official title Interventional, Randomised, Double-blind, Placebo-controlled, Fixed-dose Study of Vortioxetine in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Description The study consisted of 2 stages of 6-weeks each.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by H. Lundbeck A/S.