Treatment Resistant Depression
Conditions
Keywords
TRD
Brief 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.
Detailed 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.
Interventions
DRUGPlacebo
Placebo administered twice per day for six weeks.
DRUGCX157 (TriRima)
One tablet administered twice per day (total daily dose of 250 mg) for six weeks.
Sponsors
CeNeRx BioPharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, 20 to 65 years of age 2. Able to read, understand and converse in English and provide written, dated informed consent 3. Diagnosed with Major Depressive Disorder (MDD)and Treatment Resistant Depression(TRD) 4. Females on acceptable method of contraception
Exclusion criteria
1. Major depressive episode greater than five years 2. A history of a Substance Use Disorder with the exception of nicotine dependence in the past 12 months 3. Obsessive-Compulsive Disorder (OCD), Panic Disorder, Post-traumatic Stress Disorder (PTSD 4. A history of schizophrenia or schizoaffective disorders 5. A history of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within the past five years 6. A history of Antisocial Personality Disorder or Borderline Personality Disorder 7. Recent suicidal behavior and is at risk of such behavior during the course of the study 8. Electroconvulsive therapy (ECT) within the past five years 9. Transcranial Magnetic Stimulation (TMS) for the treatment of the current episode of depression 10. Vagus Nerve Stimulation (VNS) at any time 11. Any psychoactive drugs within one to four weeks prior to the randomization visit depending on the type of drug 12. Significant abnormality on the screening physical examination 13. Significant cardiac abnormalities such as uncontrolled hypertension, recent myocardial infarction, Congestive heart failure (CHF), Angina pectoris 14. 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 15. A history of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than six months 16. A history of hyperthyroidism which was treated (medically or surgically) less than six months prior to screening 17. Participation in an investigational study in the past one month 18. A positive screening urine test for drugs of abuse 19. Female subject who is pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) | Over six weeks of study treatment | The MADRS will be administered by a trained rater at the study site and assess symptoms of depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of illness (CGI-S); | Over six weeks of treatment with study drug. | To measure severity of depression |
| Global Improvement (CGI-I) | Over six weeks of treatment | To measure overall improvment. |
| Hospital Anxiety Depression Rating Scale (HADS) | over six weeks of treatment | To measure symptoms of depression |
Countries
United States
Outcome results
None listed