Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Treatment Resistant Depression

Intervention / Treatment
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* Drug: Placebo
* Drug: CX157 (TriRima)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 20 to 65 years of age Able to read, understand and converse in English and provide written, dated informed consent Diagnosed with Major Depressive Disorder (MDD)and Treatment Resistant Depression(TRD) Females on acceptable method of contraception Exclusion Criteria: Major depressive episode greater than five years A history of a Substance Use Disorder with the exception of nicotine dependence in the past 12 months Obsessive-Compulsive Disorder (OCD), Panic Disorder, Post-traumatic Stress Disorder (PTSD A history of schizophrenia or schizoaffective disorders A history of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within the past five years A history of Antisocial Personality Disorder or Borderline Personality Disorder Recent suicidal behavior and is at risk of such behavior during the course of the study Electroconvulsive therapy (ECT) within the past five years Transcranial Magnetic Stimulation (TMS) for the treatment of the current episode of depression Vagus Nerve Stimulation (VNS) at any time Any psychoactive drugs within one to four weeks prior to the randomization visit depending on the type of drug Significant abnormality on the screening physical examination Significant cardiac abnormalities such as uncontrolled hypertension, recent myocardial infarction, Congestive heart failure (CHF), Angina pectoris A history within the past two years of significant head trauma, surgical procedure involving the brain,degenerative central nervous system disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation A history of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than six months A history of hyperthyroidism which was treated (medically or surgically) less than six months prior to screening Participation in an investigational study in the past one month A positive screening urine test for drugs of abuse Female subject who is pregnant or lactating

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CX157 (TriRima)<br>CX157 (TriRima) in a reversible monoamine oxidase inhibitor (MAOI) | Drug: CX157 (TriRima)<br>* One tablet administered twice per day (total daily dose of 250 mg) for six weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo administered twice per day for six weeks.<br>* Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale (MADRS) | The MADRS will be administered by a trained rater at the study site and assess symptoms of depression. | Over six weeks of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of illness (CGI-S); | To measure severity of depression | Over six weeks of treatment with study drug. | 
| Global Improvement (CGI-I) | To measure overall improvment. | Over six weeks of treatment | 
| Hospital Anxiety Depression Rating Scale (HADS) | To measure symptoms of depression | over six weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TRD