Could qelbree tame ADHD and mood swings in adults?
NCT ID NCT06185985
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the drug Qelbree (viloxazine) in 161 adults with ADHD who also had mood symptoms. Participants took the medication for several weeks, and researchers tracked changes in ADHD symptoms using a standard rating scale. The goal was to see if Qelbree is both safe and effective for this specific group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Qelbree (viloxazine extended-release capsules)
- What this could lead to
- If successful, this could show that Qelbree is a safe and effective option for adults with ADHD who also have mood symptoms, potentially expanding treatment choices.
- What could go wrong
- This was an open-label trial with no placebo group, so results may be less reliable. The study is completed but not yet published, so we don't know the outcomes. Side effects are possible, as with any medication.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
161 people
The number who actually took part.
- Started
-
Mar 2024
- Finished
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Dec 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: To be eligible for participation in this study, a participant must meet all of the following criteria: 1. Is male or female, ≥18 years of age. 2. Is willing and capable of providing and signing electronic informed consent. 3. Has a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders; Fifth Edition, Text Revision (DSM-5-TR) as confirmed with the Mini-International Neuropsychiatric Interview for ADHD Studies (MINI-AS). 4. Has an AISRS Total score ≥24 at Screening. 5. Has a CGI-S score ≥3 at Screening. 6. Has a MADRS (SIGMA) Total score \>22 at Screening and/or HAM-A (SIGH-A) Total score \>22 at Screening. 7. If potential participant is a biological female, one of the following (a, b, or c) must be met: 1. Has undergone menopause, defined as a biological female who reports amenorrhea for at least 12 consecutive months prior to providing informed consent. 2. Is a non-pregnant Female of Childbearing Potential (FOCP) who is not seeking fertility treatment during the study and agrees to use one of the following acceptable birth control methods beginning 14 days prior to the first dose of study medication, throughout the study while taking study medication, and for 7 days following the last dose of study medication: i. Hormonal contraceptive; ii.Barrier method: simultaneous use of male condom and diaphragm or cervical cap with spermicidal foam/gel/film/cream/suppository. 3. Has had bilateral tubal ligation, hysterectomy, bilateral oophorectomy (permanently sterilized) at least 6 months prior to providing informed consent. 8. If potential participant is a biological male, one of the following must be met: 1. Is capable of having children and agrees to use 2 methods of contraception beginning 14 days prior to the first dose of study medication, throughout the study while taking study medication, and for 7 days following the last dose of study medication. 2. Has had sterilization surgery (permanently sterilized) at least 6 months prior to providing informed consent. 9. Owns a functioning smartphone device, has access to an internet connection (Wi-Fi or data plan), is willing to download and use the study mobile app throughout the study, and is willing to have visual telemedicine appointments (televisits) at times designated in the study protocol. Exclusion Criteria: A participant who meets any of the following criteria will be excluded from participation in the study: 1. Has a history of substance use disorder (alcohol, opioids, etc.) within the last 6 months prior to providing informed consent with exception of nicotine and cannabis. 2. Is currently taking or has taken Qelbree for treatment of ADHD in the last 3 months or is currently taking another non-stimulant medication for treatment of ADHD, like atomoxetine (Strattera), Clonidine (Catapres, Kapvay) or Guanfacine (Tenex, Intuniv). Stimulant medications for ADHD and most medications for mood symptoms (symptoms of depression and/or anxiety) are allowed. 3. Is taking a prohibited concomitant medication per the Qelbree prescribing information. 4. Is a FOCP who is pregnant, nursing, sexually active with a male partner and not willing to use one of the acceptable birth control methods throughout the study and/or is seeking fertility treatment. 5. Has a history of moderate or severe head trauma or other neurological disorder or systemic medical disease that, in the Investigator's opinion, is likely to affect central nervous system functioning. This would include participants with: 1. A current diagnosis of a major neurological disorder; or 2. Seizures, seizure disorder or seizure-like events; or a history of seizure disorder within the immediate family (siblings, parents); or 3. Encephalopathy 6. Has attempted suicide within the 6 months prior to the C-SSRS assessment at Screening, 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 behavior on the C-SSRS within the 6 months prior to the C-SSRS assessment at Screening. 7. Is currently participating in another clinical trial or has participated in a clinical trial within the 60 days prior to providing informed consent. 8. Has any history of schizophrenia, schizoaffective disorder, or bipolar disorder, or has any other psychiatric disorders in the investigator's clinical judgement would interfere with their ability to participate in the study. 9. Has any unstable, clinically significant cardiovascular condition that in the investigator's clinical judgement would preclude their participating in the study. 10. Has any disease or taking any medication that could, in the Investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with study conduct or interpretation of results. 11. History of unexplained loss of consciousness, unexplained syncope, unexplained irregular heartbeat or palpitations or near drowning with hospital admission. 12. In the Investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any other reason.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ObvioHealth
New York, New York, 10001, United States
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Other studies related to the condition(s) this trial covers.
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