- |||||||||| Review, Journal: New Pharmacologic Approaches to the Treatment of Bipolar Depression. (Pubmed Central) - May 25, 2023
New atypical anti-psychotics lumateperone and cariprazine have demonstrated efficacy in large-scale, placebo-controlled, double-blind randomized controlled trials (RCT) in treatment of BD depression...While there are potentially efficacious, mechanistically novel agents on the horizon, they require further study and validation. Further investigation on how these agents may impact specific subgroups of patients will also advance the field.
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Enrollment closed, Phase classification, Trial completion date, Trial primary completion date: SBD-ASIB: NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation (clinicaltrials.gov) - Aug 12, 2022
P3, N=72, Active, not recruiting,
Trial primary completion date: Dec 2022 --> Mar 2023 Recruiting --> Active, not recruiting | Phase classification: P2/3 --> P3 | Trial completion date: Apr 2022 --> Sep 2023 | Trial primary completion date: Mar 2022 --> Jun 2023
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Biomarker, Trial completion: NRX-GLX: NRX101 Glx Biomarker Validation Study (clinicaltrials.gov) - Aug 9, 2022
P2/3, N=8, Completed,
Recruiting --> Active, not recruiting | Phase classification: P2/3 --> P3 | Trial completion date: Apr 2022 --> Sep 2023 | Trial primary completion date: Mar 2022 --> Jun 2023 Withdrawn --> Completed
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Biomarker, Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: NRX-GLX: NRX101 Glx Biomarker Validation Study (clinicaltrials.gov) - Jul 23, 2022
P2/3, N=0, Withdrawn,
Withdrawn --> Completed N=24 --> 0 | Trial completion date: Feb 2022 --> Aug 2022 | Active, not recruiting --> Withdrawn | Trial primary completion date: Dec 2021 --> Apr 2022
- |||||||||| Review: Investigational Drugs for the Treatment of Depression (Part 2): Glutamatergic, Cholinergic, Sestrin Modulators, and Other Agents. (Pubmed Central) - Jul 20, 2022
Sestrin modulators, cholinergic receptor modulators, or onabotulinumtoxinA have also been investigated for potential antidepressant activity. In conclusion, there is hope for new treatments in uni- and bipolar depression, as it became clear, after almost 7 decades of monoamine-modulating antidepressants, that new pathogenetic pathways should be targeted to increase the response rate in this population.
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Journal: Treatment-resistant bipolar depression: concepts and challenges for novel interventions. (Pubmed Central) - May 25, 2022
Although there is no consensus about the concept of TRBD, better clarification of the neurobiology associated with treatment non-response could help identify novel strategies. More research is warranted, mainly focusing on personalizing current treatments to optimize response and remission rates.
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Phase classification, Enrollment change, Trial completion date, Trial primary completion date: MBD: NRX101 for Bipolar Depression and Sub-acute Suicidal Ideation and Behavior (clinicaltrials.gov) - Mar 31, 2022
P2, N=70, Not yet recruiting,
Not yet recruiting --> Recruiting Phase classification: P2/3 --> P2 | N=150 --> 70 | Trial completion date: Jul 2022 --> Mar 2023 | Trial primary completion date: Jun 2022 --> Dec 2022
- |||||||||| Review, Journal: Novel Glutamatergic Modulators for the Treatment of Mood Disorders: Current Status. (Pubmed Central) - Jan 7, 2022
Furthermore, to date, most have demonstrated relatively modest effects compared with (R,S)-ketamine and esketamine, though some have shown more favorable characteristics. Of these novel agents, the most promising, and the ones for which the most evidence exists, appear to be those targeting ionotropic glutamate receptors.
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Biomarker, Trial completion date, Trial primary completion date: NRX-GLX: NRX101 Glx Biomarker Validation Study (clinicaltrials.gov) - Sep 8, 2021
P2/3, N=24, Active, not recruiting,
Of these novel agents, the most promising, and the ones for which the most evidence exists, appear to be those targeting ionotropic glutamate receptors. Trial completion date: Feb 2021 --> Feb 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Trial completion date, Trial primary completion date: MBD: NRX101 for Bipolar Depression and Sub-acute Suicidal Ideation and Behavior (clinicaltrials.gov) - Sep 8, 2021
P2/3, N=150, Not yet recruiting,
Trial completion date: Dec 2021 --> Apr 2022 | Trial primary completion date: Aug 2021 --> Mar 2022 Trial completion date: Mar 2022 --> Jul 2022 | Trial primary completion date: Mar 2022 --> Jun 2022
- |||||||||| ganaxolone oral (CCD-1042) / Marinus
Review, Journal: Emerging Therapeutics Based on the Amino Acid Neurotransmitter System: An Update on the Pharmaceutical Pipeline for Mood Disorders. (Pubmed Central) - Jun 16, 2021
We cover both glutamate-targeting drugs such as: esketamine, AVP-786, REL-1017, AXS-05, rapastinel (GLYX-13), AV-101, NRX-101; as well as GABA-targeting drugs such as: brexanolone (SAGE-547), ganaxolone, zuranolone (SAGE-217), and PRAX-114. We focus the review on phase-II and phase-III clinical trials and evaluate the extant data and progress of these compounds.
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Biomarker, Trial completion date, Trial primary completion date: NRX-GLX: NRX101 Glx Biomarker Validation Study (clinicaltrials.gov) - Oct 30, 2020
P2/3, N=24, Active, not recruiting,
Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Sep 2020 --> Aug 2021 Trial completion date: Feb 2020 --> Feb 2021 | Trial primary completion date: Dec 2019 --> Dec 2020
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Trial completion date, Trial primary completion date: MBD: NRX101 for Bipolar Depression and Sub-acute Suicidal Ideation and Behavior (clinicaltrials.gov) - Oct 30, 2020
P2/3, N=150, Not yet recruiting,
Trial completion date: Feb 2020 --> Feb 2021 | Trial primary completion date: Dec 2019 --> Dec 2020 Trial completion date: Mar 2019 --> Mar 2022 | Trial primary completion date: Mar 2019 --> Mar 2022
- |||||||||| ganaxolone oral (CCD-1042) / Marinus
Review, Journal: A new generation of antidepressants: an update on the pharmaceutical pipeline for novel and rapid-acting therapeutics in mood disorders based on glutamate/GABA neurotransmitter systems. (Pubmed Central) - Aug 3, 2019
Here, we review progress in the development of compounds that act on these systems as well as their purported mechanisms of action. We include glutamate-targeting drugs, such as racemic ketamine, esketamine, lanicemine (AZD6765), traxoprodil (CP-101,606), EVT-101, rislenemdaz (CERC-301/MK-0657), AVP-786, AXS-05, rapastinel (formerly GLYX-13), apimostinel (NRX-1074/AGN-241660), AV-101, NRX-101, basimglurant (RO4917523), decoglurant (RG-1578/RO4995819), tulrampator (CX-1632/S-47445), and riluzole; and GABA-targeting agents, such as brexanolone (SAGE-547), ganaxolone, and SAGE-217.
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Enrollment open: SBD-ASIB: NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation (clinicaltrials.gov) - Jul 9, 2019
P2/3, N=72, Recruiting,
We include glutamate-targeting drugs, such as racemic ketamine, esketamine, lanicemine (AZD6765), traxoprodil (CP-101,606), EVT-101, rislenemdaz (CERC-301/MK-0657), AVP-786, AXS-05, rapastinel (formerly GLYX-13), apimostinel (NRX-1074/AGN-241660), AV-101, NRX-101, basimglurant (RO4917523), decoglurant (RG-1578/RO4995819), tulrampator (CX-1632/S-47445), and riluzole; and GABA-targeting agents, such as brexanolone (SAGE-547), ganaxolone, and SAGE-217. Active, not recruiting --> Recruiting
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Biomarker, Enrollment closed: NRX-GLX: NRX101 Glx Biomarker Validation Study (clinicaltrials.gov) - Jun 18, 2019
P2/3, N=24, Active, not recruiting,
Not yet recruiting --> Active, not recruiting | Trial completion date: Mar 2020 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Sep 2020 Recruiting --> Active, not recruiting
- |||||||||| ketamine/D-cycloserine/lurasidone (NRX-100/NRX-101) / NeuroRx, ketamine intravenous (NRX100) / NeuroRx, Cyclurad (cycloserine/lurasidone) / NeuroRx
Trial completion, Trial primary completion date: STABIL-B: Sequential Therapy for the Treatment of Severe Bipolar Depression. (clinicaltrials.gov) - Nov 30, 2018
P2, N=20, Completed,
Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial primary completion date: Dec 2018 --> Aug 2018
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Biomarker, Trial completion date, Trial initiation date, Trial primary completion date: NRX-GLX: NRX101 Glx Biomarker Validation Study (clinicaltrials.gov) - Nov 30, 2018
P2/3, N=24, Recruiting,
Active, not recruiting --> Completed | Trial primary completion date: Dec 2018 --> Aug 2018 Trial completion date: Mar 2019 --> Feb 2020 | Initiation date: Mar 2018 --> Nov 2018 | Trial primary completion date: Mar 2019 --> Dec 2019
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Trial completion date, Trial initiation date, Trial primary completion date: SBD-ASIB: NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation (clinicaltrials.gov) - Nov 30, 2018
P2/3, N=72, Not yet recruiting,
Trial completion date: Mar 2019 --> Feb 2020 | Initiation date: Mar 2018 --> Nov 2018 | Trial primary completion date: Mar 2019 --> Dec 2019 Trial completion date: Mar 2019 --> Mar 2020 | Initiation date: May 2018 --> Jan 2019 | Trial primary completion date: Mar 2019 --> Dec 2019
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Trial initiation date: MBD: NRX101 for Bipolar Depression and Sub-acute Suicidal Ideation and Behavior (clinicaltrials.gov) - Nov 30, 2018
P2/3, N=150, Not yet recruiting,
Trial completion date: Mar 2019 --> Mar 2020 | Initiation date: May 2018 --> Jan 2019 | Trial primary completion date: Mar 2019 --> Dec 2019 Initiation date: Apr 2018 --> Jan 2019
- |||||||||| ketamine/D-cycloserine/lurasidone (NRX-100/NRX-101) / NeuroRx, ketamine intravenous (NRX100) / NeuroRx, Cyclurad (cycloserine/lurasidone) / NeuroRx
Enrollment closed, Enrollment change: STABIL-B: Sequential Therapy for the Treatment of Severe Bipolar Depression. (clinicaltrials.gov) - Aug 27, 2018
P2, N=20, Active, not recruiting,
Initiation date: Apr 2018 --> Jan 2019 Recruiting --> Active, not recruiting | N=120 --> 20
- |||||||||| Cyclurad (cycloserine/lurasidone) / NeuroRx
Biomarker, Enrollment open: NRX-GLX: NRX101 Glx Biomarker Validation Study (clinicaltrials.gov) - Mar 19, 2018
P2/3, N=24, Recruiting,
N=155 --> 72 Not yet recruiting --> Recruiting
- |||||||||| ketamine/D-cycloserine/lurasidone (NRX-100/NRX-101) / NeuroRx, ketamine intravenous (NRX100) / NeuroRx, Cyclurad (cycloserine/lurasidone) / NeuroRx
Enrollment open, Phase classification: STABIL-B: Sequential Therapy for the Treatment of Severe Bipolar Depression. (clinicaltrials.gov) - Mar 8, 2018
P2, N=120, Recruiting,
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Phase classification: P2/3 --> P2
- |||||||||| ketamine/D-cycloserine/lurasidone (NRX-100/NRX-101) / NeuroRx, ketamine intravenous (NRX100) / NeuroRx, Cyclurad (cycloserine/lurasidone) / NeuroRx
Trial initiation date: STABIL-B: Sequential Therapy for the Treatment of Severe Bipolar Depression. (clinicaltrials.gov) - Jan 9, 2018
P2/3, N=120, Not yet recruiting,
Not yet recruiting --> Recruiting | Phase classification: P2/3 --> P2 Initiation date: Jun 2017 --> Jan 2018
- |||||||||| ketamine/D-cycloserine/lurasidone (NRX-100/NRX-101) / NeuroRx, ketamine intravenous (NRX100) / NeuroRx, Cyclurad (cycloserine/lurasidone) / NeuroRx
Trial initiation date: STABIL-B: Sequential Therapy for the Treatment of Severe Bipolar Depression. (clinicaltrials.gov) - Mar 27, 2017
P2/3, N=120, Not yet recruiting,
Initiation date: Jun 2017 --> Jan 2018 Initiation date: Jan 2017 --> Jun 2017
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