Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide
Completed
The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.
Gender:
ALL
Ages:
Between 9 years and 17 years
Trial Updated:
03/29/2025
Locations: Beacon Medical Group Clinical Research, South Bend, Indiana
Conditions: Depressive Disorder, Major
VA Aripiprazole vs Esketamine for Treatment Resistant Depression
Withdrawn
This is an open-label, parallel-group, randomized clinical trial of up to 6 months treatment of adjunctive intranasal (IN) esketamine (ESK) vs. adjunctive aripiprazole (ARI) in Veterans with unipolar Treatment Resistant Depression (TRD). This study will assess the efficacy, safety, and acceptability of adjunctive IN ESK in comparison to ARI, one of the best studied and most widely used adjunctive therapies for TRD. The primary hypothesis is that participants receiving adjunctive IN ESK will be s... Read More
Gender:
ALL
Ages:
Between 18 years and 74 years
Trial Updated:
01/03/2024
Locations: Richard L. Roudebush VA Medical Center, Indianapolis, IN, Indianapolis, Indiana
Conditions: Depressive Disorder, Major
Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Completed
RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy . PURPOSE: This randomized phase III trial is studying BAK gel to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/25/2017
Locations: St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana +8 locations
Conditions: Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Neurotoxicity, Pain, Unspecified Adult Solid Tumor, Protocol Specific