Clinical trial NCT01246908: Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Treatment Resistant Depression
Keywords: TRD
Lead sponsor: CeNeRx BioPharma Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-24
Enrollment: 360
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Over six weeks of study treatment
Secondary outcomes:
measure: Severity of illness (CGI-S);
timeFrame: Over six weeks of treatment with study drug.
measure: Global Improvement (CGI-I)
timeFrame: Over six weeks of treatment
measure: Hospital Anxiety Depression Rating Scale (HADS)
timeFrame: over six weeks of treatment
Other outcomes:
Locations:
city: Escondido
country: United States
facility: Synergy Escondido
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Orange
country: United States
facility: Pacific Clinical Research
state: California
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: North Miami
country: United States
facility: The Segal Institute of Clinical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Tampa
country: United States
facility: University of South Florida College of Medicine Psychiatry Center
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Winter Park
country: United States
facility: Kolin Research Group
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine and Research
state: Georgia
city: Smyrna
country: United States
facility: Nathan Shapira, MD, Ph.D
state: Georgia
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Fall River
country: United States
facility: AccelRx Research
state: Massachusetts
city: NYC
country: United States
facility: Eastside Comprehensive Medical Center
state: New York
city: Raleigh
country: United States
facility: Richard H. Weisler, M.D. and Associates
state: North Carolina
city: Beachwood
country: United States
facility: NorthCoast Clinical Trials, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites, LLC
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC
state: Ohio
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations, Inc
state: Oregon
city: Portland
country: United States
facility: Summitt Research Network (Oregon)
state: Oregon
city: Colmar
country: United States
facility: Introspect of Buxmont, Ltd
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neurosciences Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Murray
country: United States
facility: Radiant Research
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
city: Deer Brown
country: United States
facility: Northbrooke Research Center
state: Wisconsin
Study officials:
affiliation: Summitt Research Network - Oregon
name: Alan Yeo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastside Comprehensive Medical Center
name: Ram Shrivastava, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlanta Institute of Medicine and Research
name: Angelo Sambunaris, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NorthCoast Clinical Trials
name: Bijan Bastani, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stedman Clinical Trials
name: Mary Stedman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Richard H. Weisler, M.D. and Associates
name: Richard Weisler, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Neuroscience Solutions, Inc.
name: Mark Joyce, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research
name: Fares Arguello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Neurosciences Solutions, Inc.
name: Valerie Arnold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwest Clinical Research Center
name: Arif Khan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kolin Research Group
name: Irving Kolin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Excell Research
name: Jelena Kunovac, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Summit Research Network (Seattle) LLC
name: Jerry Steiert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Patient Priority Clinical Sites, LLC
name: Lorena Wallhauser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Synergy Clinical Research Center
name: Mohammed Bari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Synergy Escondido
name: Prakash Bhatia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: FutureSearch Trials of Dallas
name: Michael Downing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Community Clinical Research, Inc.
name: David Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida College of Medicine Psychiatry Center
name: Rosario Hidalgo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mclean Hospital
name: Alec Bodkin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AccelRx Research
name: Russell Pet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Center for Clinical Investigations, Inc
name: Beal Essink, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Segal Institute of Clinical Research
name: Scott Segal, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northbrooke Research Center
name: Jeffrey Simon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pacific Clinical Research
name: Charmaine Semeniuk, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gulfcoast Clinical Research Center
name: John Prater, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: North Star Medical Research LLC
name: Mark Woyshville, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Carman Research
name: Nathan Shapira, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Neuroscience Solutions, Inc.
name: Robert Molpus, MD
role: PRINCIPAL_INVESTIGATOR
References: