Investigating the Effect of Vortioxetine in Adult ADHD Patients

NCT02327013 | Completed Phase 2 Results

• 1 other identifier: 15996A
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 15

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline to Week 6

• Cognitive Function/Global Executive Function: Change in BRIEF-A Using the Global Executive Composite Score

  Baseline to Week 6

• Overall Functioning: Change in Sheehan Disability Scale (SDS) Total Score

  Baseline to Week 6

• Productivity: Change in Work Limitations Questionnaire (WLQ) Productivity Loss Score

  Baseline to Week 6

• Change in AISRS Inattention Sub-score

  Baseline to Week 6

Study Arms (3)

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.

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.

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.

Other: Placebo tablet

Interventions

vortioxetine 10 mg tablet DRUG

Oral tablets, once daily

Also known as: Brintellix®, Lu AA21004, Trintellix®

vortioxetine 10 mg tablet

vortioxetine 20 mg tablet DRUG

Oral tablets, once daily

Also known as: Brintellix®, Lu AA21004, Trintellix®

vortioxetine 20 mg tablet

Placebo tablet OTHER

Oral tablets, once daily

Placebo tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (15)

US015

Beverly Hills, California, United States

Location

US002

Garden Grove, California, United States

Location

US004

National City, California, United States

Location

US013

Bradenton, Florida, United States

Location

US006

Gainesville, Florida, United States

Location

US010

Alpharetta, Georgia, United States

Location

US014

Libertyville, Illinois, United States

Location

US011

Baltimore, Maryland, United States

Location

US009

Boston, Massachusetts, United States

Location

US016

Las Vegas, Nevada, United States

Location

US005

New York, New York, United States

Location

US008

New York, New York, United States

Location

US001

Austin, Texas, United States

Location

US007

Herndon, Virginia, United States

Location

US003

Bellevue, Washington, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Vortioxetine; Tablets

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

Combined analysis: the overall number of participants analyzed corresponds to the total number of patients in the two stage-wise analyses, where Stage 2 includes patients already included in Stage 1 (patient data not used in the combined analysis).

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

+4536301311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 30, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 7, 2018
• Results First Posted: January 31, 2018

Record last verified: 2018-02

Locations

US (15)