P3b Short-term Study of CTN in Patients With ADHD and Comorbid Anxiety (NCT06973577) | Clinical Trial Compass
CompletedPhase 3
P3b Short-term Study of CTN in Patients With ADHD and Comorbid Anxiety
United States315 participantsStarted 2025-03-26
Plain-language summary
Primary: To evaluate the efficacy of CTN in adults ages with ADHD and comorbid anxiety (AISRS) Key Secondary: To assess the efficacy of CTN in adults ages with ADHD and comorbid anxiety
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participants between 18 and 65 years of age, inclusive.
✓. Diagnosis of ADHD per the DSM-5-TR criteria and confirmed using the ACDS Version 1.2 at screening.
✓. AISRS total score of ≥ 28 at baseline.
✓. Diagnosis of GAD and/or SAD per DSM-5-TR criteria and confirmed using the MINI at screening.
✓. HAM-A total score ≥ 20 at baseline.
✓. CGI-S-ADHD and CGI-S-anxiety rating ≥ 4 at baseline.
✓. Body mass index from 18.0 to 40.0 kg/m2 (inclusive).
✓. Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
Exclusion criteria
✕. In the clinical opinion of the investigator, participant has not derived therapeutic benefit from 2 or more ADHD therapies of 2 different classes (eg, amphetamine and methylphenidate, or amphetamine and atomoxetine) given with an acceptable dose and duration during adulthood (aged 18 years or older).
✕. In the clinical opinion of the investigator, participant has not derived therapeutic benefit from 2 or more anxiety therapies of 2 different classes (eg, selegiline and duloxetine, or buspirone and lorazepam) given with an acceptable dose and duration during adulthood (aged 18 years or older).
✕
What they're measuring
1
Change in Adult Investigator Symptom Rating Scale (AISRS)
Timeframe: Baseline to Week 8
Trial details
NCT IDNCT06973577
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
. Current use of prohibited psychotropic medications that cannot be discontinued 2 weeks prior to randomization. Fluoxetine is prohibited within 28 days of randomization.
✕. Participants who have started individual or group psychotherapy within the past 3 months prior to screening (ongoing psychotherapy that is not expected to change in frequency or type during the trial is permissible).
✕. Any disorder that is the primary focus of treatment other than ADHD.
✕. Participants with lifetime DSM-5-TR diagnosis of neurocognitive disorder, schizophrenia or any psychotic disorder, bipolar disorder, autism spectrum disorder, or personality disorders. Participants with current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, any substance use disorder, eating disorders, major depressive disorder; or other anxiety disorders such as panic disorder, agoraphobia, separation anxiety disorder, selective mutism, substance or medication induced anxiety, or due to medical condition, or specific phobia will be excluded.
✕. Participant is, in the investigator's judgment, at significant risk for suicide. A participant with a Columbia-Suicide Severity Rating Scale (C-SSRS) ideation score of 4 or 5 within the last 6 months or participants who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) within the past year must be excluded.
✕. Participants with a positive UDS for illicit drugs at screening or baseline. Participants with a positive drug test at screening for ADHD or anxiety medications including methylphenidate, or amphetamines, may continue while undergoing the required washout. Participants with a positive drug test at baseline for ADHD or anxiety medications are excluded. A positive drug test at baseline for drugs of abuse, including cannabis, unless all of the following cannabis specific conditions are met: