Dr. Ann Childress Shares Her Clinical Trials Experience Treating ADHD with a Nonstimulant

QBE-2022.0272

Ann Childress, MD, a board-certified psychiatrist at Clinical Research of Southern Nevada, treats children, adolescents, and adults. She received her medical degree from the Medical University of South Carolina and completed her residency and fellowship training at the Medical University of South Carolina.

In this podcast, Dr. Childress discusses her experience with treating Attention-Deficit/Hyperactivity Disorder (ADHD) patients and compares her findings in practice with those in her clinical studies. 

Read the Transcript: 

Before we begin, I would like to introduce myself. My name is Dr. Ann Childress. I’m a consultant whose been compensated by Supernus Pharmaceuticals.

I’ve served as a principal investigator on hundreds of clinical trials working with several medications and non-medications. One of these clinical trial experiences was as a principal investigator in the Qelbree (viloxazine extended-release capsules) clinical trials. Qelbree is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder in adults and pediatric patients 6 years and older.

While I will discuss safety information about Qelbree during the podcast, please see the full Important Safety Information on this webpage, directly to the left, and the full Prescribing Information including the Boxed Warning on this webpage.

These Qelbree trials I was involved with included 5 double-blind, placebo-controlled, multicenter, 3-arm, parallel-group monotherapy studies, 4 of which I will discuss in this podcast. The studies were conducted in patients ages 6 years and older in a variety of dose ranges depending on the age. In the study P301, once-daily fixed doses of either 100 milligrams or 200 milligrams versus placebo were administered to children age 6 to 11 years. Another study, P303, was conducted in the same age group using once-daily fixed doses of 200 milligrams or 400 milligrams versus placebo. Using once-daily fixed doses of 200 milligrams or 400 milligrams versus placebo, study P302 was conducted in adolescents age 12 to 17 years. Finally, P306 was conducted in adult ADHD patients 18 years and older receiving a once-daily flexible dose ranging from 200 milligrams to 600 milligrams versus a placebo.

Additionally, these studies differed in the scoring tools used to measure the effectiveness of Qelbree. At the end of the study, patients' improvement was assessed using the following scales, whether they received active treatment or placebo. The ADHD Rating Scale—5 for children and adolescents, or the ADHD-RS-5 scale, involves quick 5-minute questionnaires for parents or teachers to fill out that assess functional impairment items for children or adolescents with ADHD. The developmentally appropriate symptom descriptions are used in the age-specific versions. The Clinical Global Impression - Improvement scale is a clinician-determined summary that provides an overall impression of how a patient compares to other patients with ADHD and allows the clinician to track patients’ progress and response to treatment over time. Used in the adult study, the Adult ADHD Investigator Symptom Rating Scale or AISRS is an investigator rating scale to evaluate aspects of ADHD in adults. Finally, the Clinical Global Impression – Severity scale (the CGI-S) is designed to compare patient severity of symptoms with those of other patients with ADHD.

I emphasize the value of using rating scales in my clinical practice to evaluate ADHD. Implementing these scales at the beginning of treatment can help guide a treatment plan.

Also, I give parent rating scales to parents of young children seeking treatment for ADHD in advance of our initial appointments for parents to read and fill out ahead of time. There are also follow-up questions asking parents to assess their children for side effects and having these responses to look over can help a physician address specific needs very efficiently, which is particularly valuable during short visits.

In the 3 clinical trials with children and adolescents 6 to 17 years of age, the primary endpoint was the change from baseline to the end of study in the ADHD-RS-5 Total Score of the 6- or 8- week study compared to placebo. The secondary endpoint was the CGI-I score at the end of the study compared to placebo. For the adult trial (P306), the primary endpoint was the change from baseline to the end of study in the AISRS total scores of the 6-week study compared to placebo. The secondary endpoint was the change from baseline in the CGI-S score at the end of the study compared to placebo.

In clinical trials, higher rates of suicidal thoughts and behaviors were reported with patients treated with Qelbree than in patients treated with placebo. Closely monitor all Qelbree-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes.

It is important to note that Qelbree met the primary endpoint in the pediatric and adolescent studies P301, P302, and P303; the change from baseline on the ADHD-RS-5 total score at end of the 6 or 8 weeks of treatment was significantly reduced with Qelbree vs. placebo. In the adult trials, Qelbree met the primary and secondary endpoints.

Advise patients that MAOIs (monoamine oxidase inhibitors) should not be taken with or within 14 days of starting Qelbree. Monitor patients for changes in blood pressure and heart rate before starting and during their treatment, as Qelbree may increase these measurements.

Several of my patients have been on stimulants and they’ve had issues with tolerability, and I have switched them to Qelbree. For example, one of my patients didn't like how she felt when she was taking her stimulant, although it successfully treated her ADHD. We prescribed Qelbree as a monotherapy about a year ago. I have another patient who tried two different stimulants and experienced some tolerability issues, so we prescribed Qelbree as a monotherapy. In both cases, the patients tolerated Qelbree and are continuing with it.

In my practice, I have found that the most problematic situations patients seek treatment for depend on the age group. Parents of young children in elementary school tend to be concerned with behavior-related symptoms; in middle and high school students, we see more symptoms of lack of focus or concentration.

For one family, the younger siblings didn’t want to interact with their teenage brother who has ADHD. Since trying Qelbree, the family has shared that the younger siblings have started asking for him and wanting to play with him. The mother has also shared she notices a difference in the teenager’s demeanor since starting on Qelbree. 

The most problematic complaint I hear from adults with ADHD involves work, such as trouble getting work done and feeling overwhelmed. For example, one patient works within the medical field. She tried other medications in the past and now takes Qelbree.

Prior to initiating treatment with Qelbree, screen patients to determine if they are at risk for bipolar disorder, as Qelbree may induce manic or mixed episodes in patients. Qelbree may cause sleepiness or fatigue, so caution patients about using Qelbree before driving or operating heavy machinery.

Several aspects of Qelbree make it stand out as a treatment option for ADHD in patients 6 years and older. One of the most beneficial features of Qelbree is that it’s a once-a-day medication with full-day exposure. Patients can take it any time of day; however, they should take it at the same time each day. If each morning doesn’t work, patients can take it each evening because it has full-day exposure. Qelbree can be taken with or without food, thus providing flexibility for patients.

I also love that it’s the only nonstimulant that we can sprinkle. This characteristic is valuable in younger patients, like my 6- to 8-year-old patients who have trouble swallowing pills. Qelbree capsules may be taken whole, or the entire contents can be sprinkled over a spoonful of pudding or applesauce. Consume the soft food mixture in its entirety, without chewing, within 15 minutes for pudding or within 2 hours for applesauce; do not store for future use. Do not cut, crush, or chew the capsules or their contents.

Furthermore, it’s significant to know that there wasn’t any evidence of abuse, withdrawal symptoms, or signs of dependence in the Qelbree clinical trials. Therefore, shortly after its FDA approval in 2021, I started using Qelbree as a treatment option for my patients in my clinical practice.

The most common side effects seen in children 6 to 17 years in medical studies were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability, and in adults in a medical study were insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation.

For those who are considering using Qelbree with their patients, Qelbree dosing is based on the dosing and titration that was done in the Phase III clinical trials. 

For children ages 6 to 11 years, start with Qelbree 100 milligrams once daily and titrate 100 milligrams each over 1 to 3 weeks as needed to reach an effective dose; the maximum dose for children is 400 milligrams once daily.

For adolescents ages 12 to 17 years, start with Qelbree 200 milligrams once daily and titrate 200 milligrams over 1 week as needed to reach an effective dose; the maximum dose for adolescents is 400 milligrams once daily.

For adults 18 years and older, start with Qelbree 200 milligrams once daily and titrate 200 milligrams each week over 1 to 2 weeks as needed to reach an effective dose; the maximum dose for adults is 600 milligrams once daily.

Patients who have severe renal failure should start with Qelbree 100 milligrams once daily and are titrated slowly to a maximum dose of 200 milligrams once daily.

Thank you for joining me today to talk about Qelbree, which is approved for the treatment of ADHD in patients 6 years and older.

Individual results may vary. Please see full Important Safety Information on this webpage, directly to the left, and the full Prescribing Information including the Boxed Warning on this webpage, directly to the right. Thank you for your time.