A Double-Blind, Randomized, Parallel-Group Study with Quetiapine Extended Release as Comparator to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients with Major Depressive Disorder with Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy
Sponsor: Janssen Research & Development
PI: Matthew Macaluso, D.O.
Clinicaltrials.gov: NCT04532749
Location: Birmingham
Contact: (205) 934-2484
A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants with Treatment-resistant Depression
Sponsor: Janssen Research & Development
PI: Matthew Macaluso, D.O.
Clinicaltrials.gov: NCT04599855
Location: Birmingham
Contact: (205) 934-2484
A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/ quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer’s type
Sponsor: Avanir Pharmaceuticals, Inc.
PI: Matthew Macaluso, D.O.
Clinicaltrials.gov: NCT04408755
Location: Birmingham
Contact: (205) 934-2484
A Phase II, 6-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group trial with a quetiapine arm to evaluate the efficacy, tolerability and safety of oral BI 1358894 in patients with Major Depressive Disorder with inadequate response to antidepressants
Sponsor: Boehringer-Ingelheim Pharmaceuticals
PI: Matthew Macaluso, D.O.
Clinicaltrials.gov: NCT04521478
Location: Birmingham
Contact: (205) 934-2484
RECOVER: A Prospective, Multi-cEnter, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Sponsor: LivaNova
PI: Matthew Macaluso, D.O.
Clinicaltrials.gov: NCT03887715
Location: Birmingham/Huntsville
Contact: (205) 934-2484 / (256) 551-4431
A Phase 2a, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-1942 Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression
Sponsor: Merck Sharp & Dohme LLC
PI: Matthew Macaluso, D.O.
Clinicaltrials.gov: NCT04663321
Location: Birmingham
Contact: (205) 934-2484
MicroRNA Correlates of Childhood Maltreatment and Suicidality
Sponsor: University of Alabama at Birmingham
PI: Yogesh Dwivedi, Ph.D.
Clinicaltrials.gov: NCT04923685
Location: Huntsville
Contact: (256) 551-4431
Neural-Derived Plasma Exosomal MicroRNAs As Promosing Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
Sponsor: University of Alabama at Birmingham
PI: Yogesh Dwivedi, Ph.D.
Clinicaltrials.gov: NCT05437588
Location: Huntsville
Contact: (256) 551-4431
A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
Sponsor: Janssen Research & Development, LLC
PI:
Clinicaltrials.gov: NCT04599855
Location: Huntsville
Contact: (256) 551-4431
Study to Assess the Efficacy and Safety of Adjunctive NBI-1065845 in Adults with Major Depressive Disorder (SAVITRI)
Sponsor: Neurocrine Biosciences
PI:
Clinicaltrials.gov: NCT05203341
Location: Huntsville
Contact: (256) 551-4431
A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated with Bipolar I Disorder
Sponsor: Sunovion
PI:
Clinicaltrials.gov: NCT05169710
Location: Huntsville
Contact: (256) 551-4431
A Study of JNJ-55308942 in the Treatment of Bipolar Depression
Sponsor: Janssen Pharmaceutica N.V., Belgium
PI:
Clinicaltrials.gov: NCT05328297
Location: Huntsville
Contact: (256) 551-4431
ENLIGHTEN: A Biomarker-Guided, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety of Liafensine in Patients with Treatment Resistant Depression
Sponsor: Denovo Biopharma LLC
PI:
Clinicaltrials.gov: NCT05113771
Location: Huntsville
Contact: (256) 551-4431
Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants with Treatment-Resistant Depression (TRD)
Sponsor: Novartis Pharmaceuticals
PI:
Clinicaltrials.gov: NCT05454410
Location: Huntsville
Contact: (256) 551-4431
A Study of Aticaprant in Adult and Elderly Participants with Major Depressive Disorders (VENTURA-LT)
Sponsor: Janssen Research & Development, LLC
PI:
Clinicaltrials.gov: NCT05518149
Location: Huntsville
Contact: (256) 551-4431