Clinical trial NCT02327013: Investigating the Effect of Vortioxetine in Adult ADHD Patients
Official title: Interventional, Randomised, Double-blind, Placebo-controlled, Fixed-dose Study of Vortioxetine in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2014-12-30
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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

Primary outcomes:
measure: Change in ADHD Investigator Symptom Rating Scale (AISRS) Total Score
timeFrame: 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
timeFrame: Baseline to Week 6
measure: Cognitive Function/Global Executive Function: Change in BRIEF-A Using the Global Executive Composite Score
timeFrame: Baseline to Week 6
measure: Overall Functioning: Change in Sheehan Disability Scale (SDS) Total Score
timeFrame: Baseline to Week 6
measure: Productivity: Change in Work Limitations Questionnaire (WLQ) Productivity Loss Score
timeFrame: Baseline to Week 6
measure: Change in AISRS Inattention Sub-score
timeFrame: Baseline to Week 6
measure: Change AISRS Hyperactivity/Impulsivity Sub-score
timeFrame: Baseline to Week 6
measure: Percentage of Patients Responding (Response Defined as 30% or Greater Reduction From Baseline in AISRS Total Score)
timeFrame: Baseline to Week 6
measure: Change in Adult ADHD Self-Report Scale (ASRS) Total Score
timeFrame: Baseline to Week 6
measure: Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
timeFrame: Baseline to Week 6
measure: Clinical Global Impression - Global Improvement (CGI-I) Score
timeFrame: Week 6
measure: Response (Defined as a CGI-I Score of 1 or 2), Stage 1
timeFrame: Week 6
measure: Change in BRIEF-A Using the Behavioural Regulation Index
timeFrame: Baseline to Week 6
measure: Change in BRIEF-A Subscales - Inhibit
timeFrame: Baseline to Week 6
measure: Change BRIEF-A Subscales - Initiate
timeFrame: Baseline to Week 6
measure: Change in BRIEF-A Subscales - Organization of Materials
timeFrame: Baseline to Week 6
measure: Change in BRIEF-A Subscales - Planning/Organize
timeFrame: Baseline to Week 6
measure: Change in BRIEF-A Subscales - Shift
timeFrame: Baseline to Week 6
measure: Change in BRIEF-A Subscales - Self Monitor
timeFrame: Baseline to Week 6
measure: Change in BRIEF-A Subscales - Task Monitor
timeFrame: Baseline to Week 6
measure: Change in BRIEF-A Subscales - Working Memory
timeFrame: Baseline to Week 6
measure: Change in BRIEF-A Subscales - Emotional Control
timeFrame: Baseline to Week 6
measure: Change in Perceived Deficits Questionnaire - Depression (PDQ-D) Total Score
timeFrame: Baseline to Week 6
measure: Change in PDQ-D Subscales - Attention and Concentration Sub-score
timeFrame: Baseline to Week 6
measure: Change in PDQ-D Sub-scales - Retrospective Memory Sub-score
timeFrame: Baseline to Week 6
measure: Change in PDQ-D Sub-scales - Prospective Memory Sub-score
timeFrame: Baseline to Week 6
measure: Change in PDQ-D Sub-scales - Planning and Organisation Sub-score
timeFrame: Baseline to Week 6
measure: Change in SDS Item Scores - Family
timeFrame: Baseline to Week 6
measure: Change in SDS Item Scores - Work
timeFrame: Baseline to Week 6
measure: Change in SDS Item Scores - Social Life
timeFrame: Baseline to Week 6
measure: Change in SDS Item Scores - Number of Days Lost
timeFrame: Baseline to Week 6
measure: Change in SDS Item Scores - Number of Underproductive Days
timeFrame: Baseline to Week 6
measure: Change in WLQ Using the Global Productivity Index
timeFrame: Baseline to Week 6
measure: Change in WLQ Domain Scores - Limitations Handling Time
timeFrame: Baseline to Week 6
measure: Change in WLQ Domain Scores - Mental-Interpersonal Work Demands
timeFrame: Baseline to Week 6
measure: Change in WLQ Domain Scores - Physical Demands
timeFrame: Baseline to Week 6
measure: Change in WLQ Domain Scores - Output Demands
timeFrame: Baseline to Week 6
measure: Change in Adult ADHD Quality of Life Measure (AAQoL) Total Score
timeFrame: Baseline to Week 6
measure: Change in AAQoL Subscales - Life Productivity Sub-score
timeFrame: Baseline to Week 6
measure: Change in AAQoL Subscales - Psychological Health Sub-score
timeFrame: Baseline to Week 6
measure: Change in AAQoL Subscales - Life Outlook Sub-score
timeFrame: Baseline to Week 6
measure: Change in AAQoL Subscales - Relationships Sub-score
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: US015
state: California
city: Garden Grove
country: United States
facility: US002
state: California
city: National City
country: United States
facility: US004
state: California
city: Bradenton
country: United States
facility: US013
state: Florida
city: Gainesville
country: United States
facility: US006
state: Florida
city: Alpharetta
country: United States
facility: US010
state: Georgia
city: Libertyville
country: United States
facility: US014
state: Illinois
city: Baltimore
country: United States
facility: US011
state: Maryland
city: Boston
country: United States
facility: US009
state: Massachusetts
city: Las Vegas
country: United States
facility: US016
state: Nevada
city: New York
country: United States
facility: US005
state: New York
city: New York
country: United States
facility: US008
state: New York
city: Austin
country: United States
facility: US001
state: Texas
city: Herndon
country: United States
facility: US007
state: Virginia
city: Bellevue
country: United States
facility: US003
state: Washington
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: