103
Participants
Start Date
July 25, 2023
Primary Completion Date
January 24, 2024
Study Completion Date
January 24, 2024
CTx-1301-Dexmethylphenidate 12.5 mg (titration only)
Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg
CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose)
Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg
CTx-1301-Dexmethylphenidate 25mg (randomized fixed dose)
Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg
CTx-1301-Dexmethylphenidate 37.5 mg (randomized fixed dose)
Subjects will be randomized at Visit 2 to CTx-1301 to 12.5mg, then week 1 to 18.75 mg, then week 2 to 25 mg, then week 3 to 37.5 mg
Placebo
Subjects will be randomized at Visit 2 to Placebo
Icahn School of Medicine at Mount Sinai, New York
Clinical Research Partners LLC, Petersburg
Coastal Carolina Research Center, North Charleston
Coastal Pediatric Associates, Charleston
Atlanta Center for Medical Research, Atlanta
Clinical Neuroscience Solutions, Inc., Jacksonville
Meridien Research, Maitland
Clinical Neuroscience Solutions, Inc., Orlando
Access Clinical Trials Inc., Nashville
Clinical Neuroscience Solutions, Inc., Memphis
Dayton Clinical Research, Dayton
Neurobehavioral Medicine Group, Bloomfield Hills
St Charles Psychiatric Associates & Midwest Research Group, Saint Charles
SP Research PLLC, Oklahoma City
FutureSearch Trials, Dallas
Red Oak Psychiatry Associates, PA, Houston
Family Psychiatry of The Woodlands, Woodland
Houston Clinical Trials, Bellaire
Gadolin Research, Beaumont
BioBehavioral Research of Austin, Austin
Center for Psychiatry and Behavioral Medicine. Inc., Las Vegas
Summit Research Network, LLC, Portland
Sisu Bhr, Llc, Springfield
Hassman Research Institute, Berlin
Lead Sponsor
Collaborators (1)
Premier Research
OTHER
Cingulate Therapeutics
INDUSTRY