Clinical Trials Logo
  1. Home
  2. Treatment Resistant Depression
  3. NCT01246908

Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression — CX157-201  

Treatment Resistant Depression Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Assessment of the Efficacy, Safety and Tolerability of CX157 Modified Release Tablet, 125 mg Twice Per Day in Subjects With Treatment Resistant Depression

Clinical Trial Summary

The purpose of this study is to determine if CX157 is effective and safe in patients with treatment of treatment resistant depression over six weeks of treatment.

Clinical Trial Description

The primary objective of this study is to examine the efficacy of CX157 Modified Release Tablet, 125 mg administered twice per day (BID) as compared to placebo in subjects with Treatment Resistant Depression (TRD). Secondary objectives are to evaluate the safety and tolerability of CX157 Modified Release Tablet, 125 mg BID in TRD subjects and characterize steady-state pharmacokinetic profile and explore pharmacodynamic relationships. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01246908
Study type Interventional
Source CeNeRx BioPharma Inc.
Contact
Status Completed
Phase Phase 2
Start date November 2010
Completion date May 2012
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04124341 - PCS in Severe Treatment Resistant Depression N/A
Recruiting NCT03887715 - 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 N/A
Completed NCT04727229 - Stellate Ganglion Block for Major Depressive Disorder. Phase 4
Completed NCT04634669 - Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE) Phase 2
Withdrawn NCT03175887 - Investigational TMS Treatment for Depression N/A
Completed NCT03134066 - Neurocognitive Features of Patients With Treatment-Resistant Depression
Active, not recruiting NCT01984710 - Deep Brain Stimulation for Treatment Resistant Depression With the Medtronic Activa PC+S N/A
Completed NCT01935115 - Comparing Ketamine and Propofol Anesthesia for Electroconvulsive Therapy Phase 4
Terminated NCT01687478 - A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression Phase 3
Completed NCT00531726 - Berlin Deep Brain Stimulation Depression Study N/A
Recruiting NCT04041479 - Biomarker-guided rTMS for Treatment Resistant Depression Phase 3
Recruiting NCT05870540 - BPL-003 Efficacy and Safety in Treatment Resistant Depression Phase 2
Recruiting NCT04959253 - Psilocybin in Depression Resistant to Standard Treatments Phase 2
Completed NCT04856124 - Intranasal Esketamine to Maintain the Antidepressant Response to IV Racemic Ketamine
Recruiting NCT03272698 - ECT With Ketamine Anesthesia vs High Intensity Ketamine With ECT Rescue for Treatment-Resistant Depression Phase 4
Active, not recruiting NCT04451135 - CET- REM (Correlating ECT Response to EEG Markers) N/A
Recruiting NCT05680220 - 40 Hz Light Neurostimulation for Patients With Depression (FELIX) N/A
Completed NCT03288675 - Stepped Care aiTBS 2 Depression Study (Ghent) N/A
Recruiting NCT06138691 - KET-RO Plus RO DBT for Treatment Resistant Depression Phase 1
Terminated NCT02675556 - Allogeneic Human Mesenchymal Stem Cells (hMSCs) Infusion in Patients With Treatment Resistant Depression Phase 1