Status:
COMPLETED
A Clinical Trial of PRAX-114 in Participants With Major Depressive Disorder
Lead Sponsor:
Praxis Precision Medicines
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of PRAX-114 in participants with moderate to severe major depressive disorder (MDD). Participant...
Eligibility Criteria
Inclusion
- Recurrent MDD diagnosis with a current episode duration of at least 8 weeks and no more than 24 months.
- HAM-D17 total score of ≥23 at Screening and Baseline.
- Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).
Exclusion
- 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.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2022
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04832425
Start Date
March 30 2021
End Date
May 5 2022
Last Update
July 21 2022
Active Locations (31)
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1
Praxis Research Site
Phoenix, Arizona, United States, 85012
2
Praxis Research Site
Garden Grove, California, United States, 92845
3
Praxis Research Site
Lafayette, California, United States, 94549
4
Praxis Research Site
Lemon Grove, California, United States, 91945