Status:
COMPLETED
A Study of CX157 (TriRima) for the Treatment of Depression
Lead Sponsor:
CeNeRx BioPharma Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine the efficacy of CX157 60 mg administered three times a day (180 mg daily dose) as compared to placebo in subjects with Major Depressive Disorder (MDD). Secondar...
Detailed Description
This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multi-center study comparing the efficacy, safety and tolerability of CX157 60mg TID and placebo. This study will be c...
Eligibility Criteria
Inclusion
- Male or female = 18 years of age and \<60 years
- Able to read, understand, converse in English
- Willing to comply with diet restrictions, concomitant medication restrictions, \& all study requirements
- Good general health as ascertained by:Medical history, Physical exam, Supine \& standing vital signs, Clinical lab evaluations, 12-lead Electrocardiogram (ECG)
- Diagnosis of MDD;
- A total score =\>40 on the IDS-SR30 assessed via IVRS at Screening and Randomization
Exclusion
- Subject's current MDD episode is \>2 years
- History of Substance Use Disorder at Screening or 12 months prior (except for nicotine)
- Current diagnosis of Obsessive-Compulsive Disorder;
- Panic Disorder or Post-Traumatic Stress Disorder;
- Anorexia nervosa, Bulimia nervosa, or eating disorder not otherwise specified;
- Any Axis I Disorder clinically predominant to their MDD (within 6 mo);
- Presence of psychotic features with current depressive episode;
- Antisocial or Borderline Personality Disorder
- At risk for suicide
- Lack of response to \>2 trials of adequate dose \& duration of antidepressants of different mechanistic classes
- Electroconvulsive therapy within 1 year of Screening
- Subject has taken any psychoactive drug within 2 weeks of Randomization
- History of cardiac abnormalities including abnormal vital sign measurements
- Clinically significant abnormal ECG at Screening
- History within past 2 years of: Significant head trauma;
- Surgical procedure involving brain or meninges; Encephalitis or meningitis;
- Degenerative CNS disorder (Alzheimer's or Parkinson's);
- Epilepsy;
- Mental retardation
- Clinically significant Liver Function Test (LFT) and other lab abnormalities
- A history of hypothyroidism and treatment with a stable dosage of thyroid replacement medication for \<6 months prior to Screening
- A history of hyperthyroidism treated (medically or surgically) \<6 months prior to Screening
- Participation in a clinical investigation of a psychotropic drug within 90 days prior to Screening OR used any other investigational drug within 60 days prior to Screening
- Presence of any medical history which includes:
- Hypersensitivity to CX157 or excipients, other MAO inhibitors, or other phenylethylamines;
- Diabetes mellitus Type I, uncontrolled Type II, or controlled Type II managed with insulin; Malignancy/chemotherapy within 2 years prior to Screening;
- Malignancy \>2 yrs may not preclude participation if the malignancy was local and without metastasis or recurrence and, if treated with chemotherapy, had no nervous system complications (e.g basal cell carcinoma);
- Pheochromocytoma
- Positive urine test for drugs of abuse (blood for alcohol)
- Female subject who is pregnant or lactating
- Poor likelihood of subject's cooperation or compliance
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT00739908
Start Date
September 1 2008
End Date
July 1 2009
Last Update
June 27 2012
Active Locations (14)
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1
Birmingham Research Group
Birmingham, Alabama, United States, 35216
2
Southwestern Research, Inc.
Beverly Hills, California, United States
3
The George Washington University
Washington D.C., District of Columbia, United States
4
Irving S. Kolin, M.D.
Winter Park, Florida, United States, 32789