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.
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.|