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Treatment Resistant DepressionPhase 2CX157-201NCT01246908

Efficacy, Safety and Tolerability of CX157 in Treatment Resistant Depression

A Phase 2 study testing CX157 (TriRima) in people with Treatment Resistant Depression, run by CeNeRx BioPharma Inc. at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Treatment Resistant Depression
What is being tested?
CX157 (TriRima)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
360 participants
Where
30 sitesUnited States
Study dates
Nov 2010to May 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Atlanta Institute of Medicine and Research

    Atlanta, Georgia, 30328

  • Community Clinical Research, Inc.

    Austin, Texas, 78754

  • NorthCoast Clinical Trials, Inc.

    Beachwood, Ohio, 44122

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • McLean Hospital

    Belmont, Massachusetts, 02478

  • Patient Priority Clinical Sites, LLC

    Cincinnati, Ohio, 45215

  • Introspect of Buxmont, Ltd

    Colmar, Pennsylvania, 18915

  • FutureSearch Trials of Dallas

    Dallas, Texas, 75231

  • Northbrooke Research Center

    Deer Brown, Wisconsin, 53223

  • Synergy Escondido

    Escondido, California, 92025

  • AccelRx Research

    Fall River, Massachusetts, 02721

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida, 33912

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32216

  • Clinical Neurosciences Solutions, Inc.

    Memphis, Tennessee, 38119

  • North Star Medical Research, LLC

    Middleburg Heights, Ohio, 44130

  • Radiant Research

    Murray, Utah, 84123

  • Synergy Clinical Research Center

    National City, California, 91950

  • Eastside Comprehensive Medical Center

    New York, New York, 10021

  • The Segal Institute of Clinical Research

    North Miami, Florida, 33161

  • Excell Research

    Oceanside, California, 92056

  • Pacific Clinical Research

    Orange, California, 92868

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32806

  • Oregon Center for Clinical Investigations, Inc

    Portland, Oregon, 97210

  • Summitt Research Network (Oregon)

    Portland, Oregon, 97210

  • Richard H. Weisler, M.D. and Associates

    Raleigh, North Carolina, 27609

  • Summit Research Network (Seattle) LLC

    Seattle, Washington, 98104

  • Nathan Shapira, MD, Ph.D

    Smyrna, Georgia, 30080

  • University of South Florida College of Medicine Psychiatry Center

    Tampa, Florida, 33163

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • Kolin Research Group

    Winter Park, Florida, 32789

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Placebo, CX157 (TriRima)
Keywords
TRD
Medical subject headings
Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Also called Sugar Pill

    Placebo administered twice per day for six weeks.

  • CX157 (TriRima)Drug

    One tablet administered twice per day (total daily dose of 250 mg) for six weeks.

Study groups in NCT01246908
Study groupRoleWhat they receive
CX157 (TriRima)ExperimentalCX157 (TriRima) in a reversible monoamine oxidase inhibitor (MAOI)
Receives: Drug: CX157 (TriRima)
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montgomery Asberg Depression Rating Scale (MADRS)

    The MADRS will be administered by a trained rater at the study site and assess symptoms of depression.

    Measured: Over six weeks of study treatment

Secondary outcomes (3)

  1. Severity of illness (CGI-S);

    To measure severity of depression

    Measured: Over six weeks of treatment with study drug.

  2. Global Improvement (CGI-I)

    To measure overall improvment.

    Measured: Over six weeks of treatment

  3. Hospital Anxiety Depression Rating Scale (HADS)

    To measure symptoms of depression

    Measured: over six weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01246908
Sponsor's protocol ID
CX157-201
Acronym
CX157-201
Status last verified
Jul 2012
First submitted
2 Nov 2010
Last updated
10 Jul 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CX157 (TriRima) in people with Treatment Resistant Depression, run by CeNeRx BioPharma Inc. at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery Asberg Depression Rating Scale (MADRS) (time frame: Over six weeks of study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01246908.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.

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