NRX-101 for Bipolar Depression With Subacute Suicidal Ideation
Completed · Phase 2/Phase 3
Conditions studied: Bipolar Depression, Suicidal Ideation and Behavior
In brief
NMDA antagonist drugs have shown to reduce symptoms of depression and suicidal ideation. NeuroRx has developed NRX-101 (fixed dose combination of D-cycloserine and lurasidone) for oral use in the treatment of bipolar depression with suicidal ideation. This study will test the hypothesis that NRX-101 is superior to lurasidone alone (standard of care) in maintaining remission from symptoms of depression (primary endpoint) and suicidal ideation or behavior (declared secondary endpoint) over a six week period of twice-daily oral dosing.
Key facts
- Study ID
- NCT03395392
- Run by
- NeuroRx, Inc.
- People needed
- 74
- Starts
- 2022-05-12
- Expected to finish
- 2024-03-30
- Last updated by the study team
- 2024-05-08
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with bipolar disorder by a qualified rater according to the criteria defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and supported by the Mini International Neuropsychiatric Interview (MINI) 7.0.2.
- Confirmed active suicidal ideation (without the intention to act) as evidenced by an answer of 'Yes' on item 3 and/or item 4 and not requiring hospitalization at Screening and an answer of "No" on item 5 of the C-SSRS.
- A total score greater than or equal to 30 on the 10 items of the MADRS.
- Subject has no co-morbidities as ascertained by medical history, physical examination (including measurement of vital signs), clinical laboratory evaluations, and electrocardiogram (ECG)
You may not qualify if…
- Subject has current DSM-5 diagnosis of moderate or severe substance use disorder (except marijuana or tobacco use disorder) within the 12 months prior to Screening.
- Subject has a lifetime history of:
- phencyclidine (PCP)/ketamine drug abuse, or
- failed use of ketamine for depression or suicidality.
- Subject has schizophrenia or schizoaffective disorder, or any history of psychotic symptoms when not in an acute bipolar mood episode.
- Subject has a current major psychiatric disorder, diagnosed at Screening
- Subject has been prescribed more than one agent in each of the following categories at randomization:
- Approved SSRIs
- Approved serotonin and norepinephrine reuptake inhibitors (SNRIs)
- Approved tetracyclic antidepressants (TeCAs)
- Approved Mood stabilizers (e.g., lithium, valproic acid, and lamotrigine)
- Subject has signs and symptoms of active or residual COVID-19, or unresolved symptoms of COVID-19 that impact health
Where it is running
- Science 37 — Culver City, California, United States
- San Marcus Research Clinic, Inc. — Miami Lakes, Florida, United States
- ACMR — Atlanta, Georgia, United States
- iResearch Atlanta, LLC — Decatur, Georgia, United States
- iResearch Savannah — Savannah, Georgia, United States
- CBH Health — Gaithersburg, Maryland, United States
- Omaha Insomnia and Psychiatric Services — Omaha, Nebraska, United States
- Dent Neurologic Institute — Amherst, New York, United States
- Peace Health Medical Group — Eugene, Oregon, United States
- University of Texas Health Austin — Austin, Texas, United States
- Roots Behavioral Health — Austin, Texas, United States
- JPS Health — Fort Worth, Texas, United States
- Houston Mind and Brain — Houston, Texas, United States
- Health Texas — Richmond, Texas, United States
Full record on ClinicalTrials.gov
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