Clinical Trial of PRAX-114 to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy in Participants with Major Depressive Disorder

A Phase 2 Clinical Trial of PRAX-114 to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy in Participants with Major Depressive Disorder

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000575134

Enrollment

Registered

2019-04-12

Start date

2019-05-21

Completion date

2021-04-29

Last updated

2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a clinical trial of PRAX-114 to assess the safety, tolerability, PK, and efficacy in participants with moderate to severe MDD. Each participant will complete 3 study periods: Screening, Treatment Period (14 days) and Safety Follow-up.

Interventions

Part A (inpatient and outpatient) and Part B (outpatient only): PRAX-114 60mg orally once daily for 14 days Part C: PRAX-114 60mg orally once daily for 27 days

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

For Part A: - Male or females between the ages of 18 and 65 years - Clinical diagnosis of major depressive disorder (MDD) - Chronic medications or interventions must be stable for at least 4 weeks prior to Screening and remain stable throughout the clinical trial - Willing to comply with the protocol (including inpatient stay) For Part B: - Females 40 years of age or older with irregular menses - Historical self-report of vasomotor symptoms - Clinical diagnosis of major depressive disorder (MDD) - Chronic medications or interventions must be stable for at least 4 weeks prior to Screening and remain stable throughout the clinical trial - Willing to comply with the protocol For Part C: - Male or females between the ages of 18 and 65 years - Clinical diagnosis of major depressive disorder (MDD) - Chronic medications or interventions must be stable for at least 4 weeks prior to Screening and remain stable throughout the clinical trial - Willing to comply with the protocol

Exclusion criteria

- Clinically significant unstable medical or psychiatric condition, other than MDD - History of treatment resistant depression (failed 3 adequate trials of antidepressant therapy) - History of a suicide attempt in last 2 years - History of bipolar disorder - History of a psychotic episode in last 2 years - History of alcohol abuse in last 2 years - History of substance abuse in last 2 years - History of seizures in last 5 years

Outcome results