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

Praxis Precision Medicines

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: 10 mg PRAX-114; Drug: 40 mg PRAX-114; Drug: 60 mg PRAX-114; Drug: 20 mg PRAX-114

Study type: Interventional

Funder types: Industry

Identifiers

NCT04969510

PRAX-114-214

Details and patient eligibility

About

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.

Enrollment: 110 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 12 weeks and no more than 24 months.
2. HAM-D17 total score of ≥20 at Screening and Baseline
3. Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).
4. 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.
5. 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.

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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110 participants in 5 patient groups, including a placebo group

PRAX-114 (10 mg)

Experimental group

Description:

10 mg PRAX-114 once daily

Treatment:

Drug: 10 mg PRAX-114

PRAX-114 (20 mg)

Experimental group

Description:

20 mg PRAX-114 once daily

Treatment:

Drug: 20 mg PRAX-114

PRAX-114 (40 mg)

Experimental group

Description:

40 mg PRAX-114 once daily

Treatment:

Drug: 40 mg PRAX-114

PRAX-114 (60 mg)

Experimental group

Description:

60 mg PRAX-114 once daily

Treatment:

Drug: 60 mg PRAX-114

Placebo

Placebo Comparator group

Description:

Placebo once daily

Treatment:

Drug: Placebo