Investigating the Effect of Vortioxetine in Adult ADHD Patients

NCT ID: NCT02327013

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-09-30

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

vortioxetine 10 mg tablet

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.

Group Type: EXPERIMENTAL

vortioxetine 10 mg tablet

Intervention Type: DRUG

Oral tablets, once daily

vortioxetine 20 mg tablet

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.

Group Type: EXPERIMENTAL

vortioxetine 20 mg tablet

Intervention Type: DRUG

Oral tablets, once daily

Placebo tablet

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.

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: OTHER

Oral tablets, once daily

Interventions

vortioxetine 10 mg tablet

Oral tablets, once daily

Intervention Type: DRUG

vortioxetine 20 mg tablet

Oral tablets, once daily

Intervention Type: DRUG

Placebo tablet

Oral tablets, once daily

Intervention Type: OTHER

Other Intervention Names

Brintellix®; Lu AA21004; Trintellix®; Brintellix®; Lu AA21004; Trintellix®

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

US015

Beverly Hills, California, United States

US002

Garden Grove, California, United States

US004

National City, California, United States

US013

Bradenton, Florida, United States

US006

Gainesville, Florida, United States

US010

Alpharetta, Georgia, United States

US014

Libertyville, Illinois, United States

US011

Baltimore, Maryland, United States

US009

Boston, Massachusetts, United States

US016

Las Vegas, Nevada, United States

US005

New York, New York, United States

US008

New York, New York, United States

US001

Austin, Texas, United States

US007

Herndon, Virginia, United States

US003

Bellevue, Washington, United States

Countries

United States

Other Identifiers

15996A

Identifier Type: -

Identifier Source: org_study_id