NRX101 for Moderate Bipolar Depression and Suicidal Ideation (MBD)
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|ClinicalTrials.gov Identifier: NCT03395392|
Recruitment Status : Not yet recruiting
First Posted : January 10, 2018
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Depression Suicidal Ideation||Drug: NRX-101 Drug: Lurasidone HCl||Phase 2 Phase 3|
Background and Rationale: NMDA antagonist drugs have increasingly been demonstrated to reduce symptoms of depression and suicidal ideation. Specifically, NRX-100 (ketamine HCl, 0.5 mg/kg IV over 40 minutes) has been shown to induce acute reductions in suicidality and depression in patients with bipolar depression, relative to control. Numerous reports have documented a 50% reduction in the MADRS depression scale and a 75% reduction in suicidality following a single infusion of ketamine in patients with suicidal ideation and depression. While the repeat use of ketamine is not supported and may be contraindicated by the literature, D-cycloserine (DCS), when combined with SSRI antidepressants in patients with treatment resistant depression, and when combined with atypical antipsychotics, in particular lurasidone (NRX-101), has shown separation from control and ability to maintain remission from suicidality and depression over 6 weeks with oral use.
- To test the hypothesis that treatment with NRX-101 is superior to lurasidone in maintaining improvement in symptoms of depression as measured by the Montgomery Asberg Depression Rating Score (MADRS).
- To test the hypothesis that patients treated with NRX-101 are less likely to experience treatment failure than those treated with standard of care. Treatment failure is defined as a 25% or greater return to baseline levels of depression or suicidality, or the need to implement a new treatment plan.
- To demonstrate that patients treated with NRX-101 are less likely to suffer from akathisia than those treated with lurasidone.
- To demonstrate safety and tolerability for both NRX-101 vs. lurasidone.
Methodology: A multi-center, randomized, double-blind, trial in which patients with moderate levels of bipolar depression (MADRS >20) and subacute levels of suicidal ideation (C-SSRS 2 or 3) are randomized to receive twice daily oral NRX-101 or lurasidone (standard of care).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Participants and Care Providers will be masked with regard to medication administered.|
|Official Title:||NRX-101 for Treatment of Moderate Bipolar Depression and Suicidal Ideation The MBD Study|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||March 31, 2019|
Following study enrollment and randomization, subjects will receive twice daily NRX-101
NRX-101, a fixed dose combination of D-cycloserine+lurasidone will be given twice a day by mouth
Active Comparator: Lurasidone
Following study enrollment, subjects will receive twice daily lurasidone
Drug: Lurasidone HCl
Lurasidone HCl will be given twice a day by mouth
- Depression [ Time Frame: Six weeks ]Mean change from baseline on the Montgomery Asberg Depression Rating Scale. (MADRS) Relative to Standard of Care. The MADRS is a 10 item scale with each item scored from 0 to 6 where 0 represents minimal symptoms and 6 represents maximum response to that item. The total MADRS score ranges from 0 to 60.
- Time to Treatment Failure [ Time Frame: 6 weeks ]Relapse is defined as a 25% or greater return to baseline level of depression on the MADRS, or suicidality, or the need to implement a new treatment plan.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395392
|Contact: Fred Grossman, DO||484-254-6134 ext firstname.lastname@example.org|
|Study Director:||Fred Grossman, DO||Chief Medical Officer, NeuroRx, Inc.|