Attention Deficit Hyperactivity DisorderPhase 2NCT02327013
Investigating the Effect of Vortioxetine in Adult ADHD Patients
A Phase 2 study testing vortioxetine 10 mg tablet and vortioxetine 20 mg tablet in people with Attention Deficit Hyperactivity Disorder, run by H. Lundbeck A/S at 15 sites in United States.
Trial summary
The purpose is to determine the effect of vortioxetine treatment on ADHD symptoms in adult patients with ADHD in a 12 weeks study. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- vortioxetine 10 mg tablet and vortioxetine 20 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- 15 sitesUnited States
- Study dates
- Dec 2014to Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
US010
Alpharetta, Georgia
US001
Austin, Texas
US011
Baltimore, Maryland
US003
Bellevue, Washington
US015
Beverly Hills, California
US009
Boston, Massachusetts
US013
Bradenton, Florida
US006
Gainesville, Florida
US002
Garden Grove, California
US007
Herndon, Virginia
US016
Las Vegas, Nevada
US014
Libertyville, Illinois
US004
National City, California
US005
New York, New York
US008
New York, New York
About this study
Official title: Interventional, Randomised, Double-blind, Placebo-controlled, Fixed-dose Study of Vortioxetine in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
The purpose is to determine the effect of vortioxetine treatment on ADHD symptoms in adult patients with ADHD in a 12 weeks study.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- vortioxetine 10 mg tablet, vortioxetine 20 mg tablet, Placebo tablet
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vortioxetine 10 mg tabletDrug
Also called Brintellix®, Lu AA21004, Trintellix®
Oral tablets, once daily
vortioxetine 20 mg tabletDrug
Also called Brintellix®, Lu AA21004, Trintellix®
Oral tablets, once daily
Placebo tabletOther
Oral tablets, once daily
| Study group | Role | What they receive |
|---|---|---|
| vortioxetine 10 mg tablet | Experimental | In Stage 1, patients will receive vortioxetine 10mg/day for 6 weeks.
In Stage 2, patients who received vortioxetine 10mg/day in Stage 1 will continue on the same treatment for additionally 6 weeks. Placebo non-responders will be re-randomized to placebo, or vortioxetine 10 or 20mg/day for additionally 6 weeks. Receives: Drug: vortioxetine 10 mg tablet |
| vortioxetine 20 mg tablet | Experimental | In Stage 1, patients will receive vortioxetine 20mg/day for 6 weeks.
In Stage 2, patients who received vortioxetine 20mg/day in Stage 1 will continue on the same treatment for additionally 6 weeks. Placebo non-responders will be re-randomized to placebo, or vortioxetine 10 or 20mg/day for additionally 6 weeks. Receives: Drug: vortioxetine 20 mg tablet |
| Placebo tablet | Placebo comparator | In Stage 1, the patients will receive placebo for 6 weeks.
In Stage 2, placebo responders will continue on placebo for additionally 6 weeks. Placebo non-responders will be re-randomized to placebo, or vortioxetine 10 or 20mg/day for additionally 6 weeks. Receives: Other: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD Investigator Symptom Rating Scale (AISRS) Total Score
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.
Measured: Baseline to Week 6
Secondary outcomes (41)
Inattention/Meta-cognition: Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Using Metacognition Index
The Metacognition Index (MI) is an index score of the BRIEF-A consisting of 5 scales: initiate, working memory, plan/organise, task monitor, and organization of materials. Each item is rated on a 3-point scale with the numeric score of 1 to 3. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Cognitive Function/Global Executive Function: Change in BRIEF-A Using the Global Executive Composite Score
BRIEF-A is a validated questionnaire composed of 75-item within nine non-overlapping scales: 4 scales in the Behavioral Regulation Index (BRI) (inhibit, shift, emotional control, and self-monitor), and 5 scales in the Metacognition Index (MI) (initiate, working memory, plan/organise, task monitor, and organization of materials). Each item is rated on a 3-point scale with the numeric score of 1 to 3. The BRIEF-A yields an overall score (Global Executive Composite) composed of two index scores, the MI and the BRI. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Overall Functioning: Change in Sheehan Disability Scale (SDS) Total Score
The SDS comprises a series of patient rated scales designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and 3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment. The number of days lost and the number of underproductive days last from work/school due to symptoms are also captured. The total score is calculated as a sum of the 3 visual analogue scales, ranges from 0 to 30. A higher score represents more severe functional impairment. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Productivity: Change in Work Limitations Questionnaire (WLQ) Productivity Loss Score
The WLQ is a patient self-rated scale designed to assess on-the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental-interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5-point scale from "All of the Time" (score 5) to "None of the Time" (score 0), or "Does Not Apply to My Job". The WLQ Productivity Loss Score is derived from the Global Productivity Index, which is calculated as a weighed sum of the 4 dimensions. Reduction in WLQ Productivity Loss score indicates less work limitation and represents the estimated percentage of productivity loss in the past two weeks due to presenteeism relative to a healthy benchmark sample. WLQ Productivity Loss Score ranges from 0% to 24,9%.
Measured: Baseline to Week 6
Change in AISRS Inattention Sub-score
The AISRS inattentive subscale score consists of 9 items from the AISRS which address inattention. Each item is rated from 0 to 3. The AISRS inattentive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD inattentiveness.
Measured: Baseline to Week 6
Change AISRS Hyperactivity/Impulsivity Sub-score
The AISRS hyperactive/impulsive subscale score consists of 9 items from the AISRS which address hyperactivity and impulsivity. Each item is rated from 0 to 3. The AISRS hyperactive/impulsive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD hyperactivity/impulsivity.
Measured: Baseline to Week 6
Percentage of Patients Responding (Response Defined as 30% or Greater Reduction From Baseline in AISRS Total Score)
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.
Measured: Baseline to Week 6
Change in Adult ADHD Self-Report Scale (ASRS) Total Score
The Adult ADHD Self-Report Scale (ASRS) is a patient-rated scale designed to assess the ADHD symptoms in adults based on the diagnostic criteria of DSM-IVTM. The ASRS consist of 18 items, each rated on a 5-point scale from "Never" to "Very Often". The categories "Never" and "Rarely" were combined when calculating the total score to mirror the scoring of the AISRS, with 0 representing "Never"/"Rarely" and 3 representing "Very Often". The Total Score ranges from 0 to 54. A reduction in score indicates less severity of ADHD.
Measured: Baseline to Week 6
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening.
Measured: Baseline to Week 6
Clinical Global Impression - Global Improvement (CGI-I) Score
The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicate worsening.
Measured: Week 6
Response (Defined as a CGI-I Score of 1 or 2), Stage 1
The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicate worsening.
Measured: Week 6
Change in BRIEF-A Using the Behavioural Regulation Index
The Behavioral Regulation Index (BRI) is an index score of the BRIEF-A and consists of 4 scales: inhibit, shift, emotional control, and self-monitor). Each item is rated on a 3-point scale with the numeric score of 1 to 3. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in BRIEF-A Subscales - Inhibit
The BRIEF-A subscale Inhibit is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change BRIEF-A Subscales - Initiate
The BRIEF-A subscale Initiate is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in BRIEF-A Subscales - Organization of Materials
The BRIEF-A subscale Organization of Materials is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in BRIEF-A Subscales - Planning/Organize
The BRIEF-A subscale Planning/Organize is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in BRIEF-A Subscales - Shift
The BRIEF-A subscale Shift is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in BRIEF-A Subscales - Self Monitor
The BRIEF-A subscale Self Monitor is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in BRIEF-A Subscales - Task Monitor
The BRIEF-A subscale Task Monitor is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in BRIEF-A Subscales - Working Memory
The BRIEF-A subscale Working Memory is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in BRIEF-A Subscales - Emotional Control
The BRIEF-A subscale Emotional Control is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in Perceived Deficits Questionnaire - Depression (PDQ-D) Total Score
The PDQ-D is a patient-rated scale designed to assess cognitive impairment/dysfunction adapted for MDD. Each item is rated on a scale from 0 (never) to 4 (almost always). The total score of the 20 items ranges from 0 to 80 with higher scores reflect greater subjective cognitive impairment. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in PDQ-D Subscales - Attention and Concentration Sub-score
The PDQ-D attention/concentration sub-score consists of items 1, 5, 9, 13, and 17 of the PDQ with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.
Measured: Baseline to Week 6
Change in PDQ-D Sub-scales - Retrospective Memory Sub-score
The PDQ-D retrospective memory sub-score consists of items 2, 6, 10, 14, and 18 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.
Measured: Baseline to Week 6
Change in PDQ-D Sub-scales - Prospective Memory Sub-score
The PDQ-D prospective memory sub-score consists of items 3, 7, 11, 15, and 19 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.
Measured: Baseline to Week 6
Change in PDQ-D Sub-scales - Planning and Organisation Sub-score
The PDQ-D planning and organisation sub-score consists of items 4, 8, 12, 16, and 20 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.
Measured: Baseline to Week 6
Change in SDS Item Scores - Family
The SDS item family is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in SDS Item Scores - Work
The SDS item work is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in SDS Item Scores - Social Life
The SDS item social life is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in SDS Item Scores - Number of Days Lost
This SDS item captures days lost from school or work (see outcome 4).
Measured: Baseline to Week 6
Change in SDS Item Scores - Number of Underproductive Days
This SDS item captures the number of underproductive days (see outcome 4)
Measured: Baseline to Week 6
Change in WLQ Using the Global Productivity Index
The WLQ is a patient self-rated scale designed to assess on-the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental-interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5-point scale from "All of the Time" (score 5) to "None of the Time" (score 0), or "Does Not Apply to My Job". The Global Productivity Index is calculated as a weighed sum of the 4 dimensions, and ranges from 0.000 to 0.286. Reduction in score indicates less work limitation.
Measured: Baseline to Week 6
Change in WLQ Domain Scores - Limitations Handling Time
Limitations Handling Time is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.
Measured: Baseline to Week 6
Change in WLQ Domain Scores - Mental-Interpersonal Work Demands
Mental-Interpersonal Work Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.
Measured: Baseline to Week 6
Change in WLQ Domain Scores - Physical Demands
Physical Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.
Measured: Baseline to Week 6
Change in WLQ Domain Scores - Output Demands
Output Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.
Measured: Baseline to Week 6
Change in Adult ADHD Quality of Life Measure (AAQoL) Total Score
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Total score is based on all 29 items and ranges from 29 to 145. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in AAQoL Subscales - Life Productivity Sub-score
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Life productivity subscale is based on 11 items and ranges from 11 to 55. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in AAQoL Subscales - Psychological Health Sub-score
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Psychological Health subscale is based on 6 items and ranges from 6 to 30. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in AAQoL Subscales - Life Outlook Sub-score
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Life Outlook subscale is based on 7 items and ranges from 7 to 35. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Change in AAQoL Subscales - Relationships Sub-score
The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Relationship subscale is based on 5 items and ranges from 5 to 25. A reduction in score indicates less impairment.
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327013
- Sponsor's protocol ID
- 15996A
- Status last verified
- Feb 2018
- First submitted
- 18 Dec 2014
- Last updated
- 7 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomised, Double-blind, Placebo-controlled, Fixed-dose Study of Vortioxetine in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02327013
- Acronym / sponsor ID
- 15996A
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Posted 31 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vortioxetine 10 mg tablet | Experimental | Drug: vortioxetine 10 mg tabletIn Stage 1, patients will receive vortioxetine 10mg/day for 6 weeks. In Stage 2, patients who received vortioxetine 10mg/day in Stage 1 will continue on the same treatment for additionally 6 weeks. Placebo non-responders will be re-randomized to placebo, or vortioxetine 10 or 20mg/day for additionally 6 weeks. |
| vortioxetine 20 mg tablet | Experimental | Drug: vortioxetine 20 mg tabletIn Stage 1, patients will receive vortioxetine 20mg/day for 6 weeks. In Stage 2, patients who received vortioxetine 20mg/day in Stage 1 will continue on the same treatment for additionally 6 weeks. Placebo non-responders will be re-randomized to placebo, or vortioxetine 10 or 20mg/day for additionally 6 weeks. |
| Placebo tablet | Placebo comparator | Other: Placebo tabletIn Stage 1, the patients will receive placebo for 6 weeks. In Stage 2, placebo responders will continue on placebo for additionally 6 weeks. Placebo non-responders will be re-randomized to placebo, or vortioxetine 10 or 20mg/day for additionally 6 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vortioxetine 10 mg tabletAlso: Brintellix®, Lu AA21004, Trintellix®Oral tablets, once daily | Drug | vortioxetine 10 mg tablet |
| vortioxetine 20 mg tabletAlso: Brintellix®, Lu AA21004, Trintellix®Oral tablets, once daily | Drug | vortioxetine 20 mg tablet |
| Placebo tabletOral tablets, once daily | Other | Placebo tablet |
Primary outcome
Change in ADHD Investigator Symptom Rating Scale (AISRS) Total Score
Time frame: Baseline to Week 6
AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.
41 secondary outcomes
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 Score
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 Limitations Questionnaire (WLQ) 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
Percentage of Patients Responding (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), Stage 1
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) Total 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vortioxetine 10 mg tablet and vortioxetine 20 mg tablet in people with Attention Deficit Hyperactivity Disorder, run by H. Lundbeck A/S at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADHD Investigator Symptom Rating Scale (AISRS) Total Score (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.