Condition: Major Depressive Disorder · Sponsor: Praxis Precision Medicines
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Praxis Research Site | Phoenix, Arizona, United States | — |
| Praxis Research Site | Garden Grove, California, United States | — |
| 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 | Pico Rivera, 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 | — |
+ 19 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.