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Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.

NCT05631626 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-08-14

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in adults with ADHD in a laboratory classroom setting.

Conditions

  • ADHD
  • ADHD - Combined Type
  • Attention Deficit Hyperactivity Disorder Combined
  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

CTx-1301 - Dexmethylphenidate 25mg

25mg CTx-1301 (Dexmethylphenidate tablet)

DRUG

CTx-1301 - Dexmethylphenidate 37.5mg

37.5mg CTx-1301 (Dexmethylphenidate tablet)

DRUG

CTx-1301 - Dexmethylphenidate 50mg

50mg CTx-1301 (Dexmethylphenidate tablet)

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Rho, Inc.

    collaborator INDUSTRY

  • Cingulate Therapeutics

    lead INDUSTRY

Principal Investigators

  • Ann Childress, MD · Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-29
Primary Completion
2023-06-13
Completion
2023-06-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05631626 on ClinicalTrials.gov