A Clinical Trial of Adjunctive and Monotherapy PRAX-114 in Participants With Major Depressive Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of 10, 20, 40 and 60 mg oral PRAX-114 compared to placebo in the treatment of adults with MDD. The study will enroll participants on adjunctive treatment who had an inadequate response to their current antidepressant treatment and participants not currently being treated with pharmacotherapy for MDD. A sub-study to investigate the pharmacokinetics (PK) of PRAX-114 and metabolites when dosed in the evening in participants with MDD will be conducted in a subset of participants at selected research sites with serial PK sampling capabilities.

Key facts

Study ID

NCT04969510

Run by

Praxis Precision Medicines

People needed

110

Starts

2021-06-24

Expected to finish

2022-08-02

Last updated by the study team

2022-08-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recurrent MDD diagnosis with a current episode duration of at least 12 weeks and no more than 24 months.
• HAM-D17 total score of ≥20 at Screening and Baseline
• Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).
• Adjunctive treatment participants only: Inadequate response to treatment in the current MDD episode, defined as <50% reduction in depression severity in response to at least 1 and no more than 2 antidepressant trials at an adequate dose and duration in the current MDE as specified in the ATRQ.
• Adjunctive treatment participants only: Stable regimen of antidepressant treatment for at least 8 weeks prior to Baseline, with no clinically meaningful change (defined as no increase in dose and no decrease in dose ≥25% for tolerability) during that period.

You may not qualify if…

• Lifetime history of seizures, including febrile seizures.
• Neurodegenerative disorder (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, or Huntington's disease).
• Lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive compulsive disorder or a history of a psychotic mood episode in last 2 years.
• Any current psychiatric disorder (other than MDD).
• Lifetime history of treatment resistant depression.
• Received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) within the last year or transcranial magnetic stimulation (TMS) within the last 6 months prior to Screening.
• Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.

Where it is running

• Praxis Research Site — Lafayette, California, United States
• Praxis Research Site — Lemon Grove, California, United States
• Praxis Research Site — Oceanside, California, United States
• Praxis Research Site — Redlands, California, United States
• Praxis Research Site — Jacksonville, Florida, United States
• Praxis Research Site — Orange City, Florida, United States
• Praxis Research Site — Orlando, Florida, United States
• Praxis Research Site — Atlanta, Georgia, United States
• Praxis Research Site — Decatur, Georgia, United States
• Praxis Research Site — Gaithersburg, Maryland, United States
• Praxis Research Site — Boston, Massachusetts, United States
• Praxis Research Site — Worcester, Massachusetts, United States
• Praxis Research Site — O'Fallon, Missouri, United States
• Praxis Research Site — Las Vegas, Nevada, United States
• Praxis Research Site — Cedarhurst, New York, United States
• Praxis Research Site — Rochester, New York, United States
• Praxis Research Site — Dayton, Ohio, United States
• Praxis Research Site — Allentown, Pennsylvania, United States
• Praxis Research Site — Media, Pennsylvania, United States
• Praxis Research Site — Memphis, Tennessee, United States
• Praxis Research Site — Austin, Texas, United States
• Praxis Research Site — Charlottesville, Virginia, United States
• Praxis Research Site — Everett, Washington, United States
• Praxis Research Site — Noble Park, Victoria, Australia

Full record on ClinicalTrials.gov

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