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

Praxis Precision Medicines

Status and phase: Completed; Phase 3; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: PRAX-114; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04832425

PRAX-114-213

Details and patient eligibility

About

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). Participants will be randomized to receive 28 days of either 40 mg PRAX-114 or placebo in a 1:1 ratio.

Enrollment: 216 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Recurrent MDD diagnosis with a current episode duration of at least 8 weeks and no more than 24 months.
2. HAM-D17 total score of ≥23 at Screening and Baseline.
3. Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).

Exclusion criteria

1. Lifetime history of seizures, including febrile seizures.
2. Neurodegenerative disorder (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, or Huntington's disease).
3. 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.
4. Any current psychiatric disorder (other than MDD).
5. Lifetime history of treatment resistant depression.
6. 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.
7. Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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216 participants in 2 patient groups, including a placebo group

PRAX-114

Experimental group

Description:

40 mg PRAX-114 once daily

Treatment:

Drug: PRAX-114

Placebo

Placebo Comparator group

Description:

Placebo once daily

Treatment:

Drug: Placebo