Ketamine for Bipolar Depression and Suicidal Thoughts

(SevereBD Trial)

Recruiting at 1 trial location

Overseen By Martin Brecher, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NeuroRx, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 0

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a treatment that starts with a ketamine injection to quickly reduce severe depression and suicidal thoughts, followed by maintenance pills. It targets patients with severe bipolar depression who need rapid symptom relief. Ketamine rapidly alters brain activity, and the pills help maintain these positive changes. Ketamine has shown effectiveness as a rapid-acting antidepressant with antisuicidal effects, but evidence for long-term maintenance therapy is limited.

Research Team

Martin Brecher, MD

Principal Investigator

VP, Clinical Development, NeuroRx, Inc.

Eligibility Criteria

This trial is for adults aged 18-65 with severe bipolar depression and recent suicidal thoughts or behaviors. Participants must understand the study, be likely to follow its rules, have a stable living situation, and use effective birth control if applicable. They can't join if they're pregnant or don't meet health requirements.

Inclusion Criteria

The subject had a negative urinary pregnancy test at both the screening and randomization visits, confirming that she was not pregnant.

The individual resides in a stable living situation and has an identified reliable informant who agrees that the individual has bipolar disorder

Not able to have children (e.g., physically incapable of becoming pregnant, permanently sterilized, or post-menopausal); using any form of hormonal birth control, on hormone replacement therapy started prior to 12 months of amenorrhea, using an intrauterine device (IUD), having a monogamous relationship with a partner who has had a vasectomy, or not sexually active.

Treatment Details

Interventions

• NRX100
• Placebo

Trial Overview The trial tests NRX-100 (ketamine HCL) against a placebo for quick relief of depression and suicidal thoughts in bipolar disorder patients. It aims to see if NRX-100 works better than a placebo within 24 hours after taking it.

Participant Groups

Group I: Saline (placebo) infusion Experimental Treatment 1 Intervention

Infusion of IV Saline

Group II: NRX-100 infusion Experimental Treatment 1 Intervention

Infusion of IV NRX-100 (ketamine)

Who Is Running the Clinical Trial?

NeuroRx, Inc.

Lead Sponsor

Trials

14

Recruited

1,600+

Target Health Inc.

Industry Sponsor

Trials

7

Recruited

520+