Major Depressive DisorderPhase 2CX157-200NCT00739908
A Study of CX157 (TriRima) for the Treatment of Depression
A Phase 2 study testing CX157 (TriRima) in people with Major Depressive Disorder, run by CeNeRx BioPharma Inc. at 14 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- 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
- 285 participants
- Where
- 14 sitesUnited States
- Study dates
- Sep 2008to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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);
Show all 31Show fewer
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
FutureSearch Trials
Austin, Texas, 78756
McLean Hospital
Belmont, Massachusetts
Southwestern Research, Inc.
Beverly Hills, California
Birmingham Research Group
Birmingham, Alabama, 35216
Northbrooke Research Center
Brown Deer, Wisconsin
CRI Worldwide, LLC
Clementon, New Jersey
Fieve Clinical Services
New York, New York
Midwest Center for Neurobehavioral Medicine
Oakbrook Terrace, Illinois
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania
Richard H. Weisler, M.D., P.A.
Raleigh, North Carolina
Capital Clinical Research Associates
Rockville, Maryland
Summit Research Network (Seattle), LLC
Seattle, Washington
The George Washington University
Washington D.C., District of Columbia
Irving S. Kolin, M.D.
Winter Park, Florida, 32789
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Parallel-Group, Assessment of the Efficacy, Safety and Tolerability of CX157 (TriRima) 60mg Three Times a Day (TID) in Subjects With Major Depressive Disorder
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). Secondary objectives are to evaluate the safety and tolerability and steady state pharmacokinetic profile of CX157 in these subjects.
Read the 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 conducted at approximately 12 investigative sites in the US.
Subjects with suspected Major Depressive Disorder (MDD) and experiencing a Major Depressive Episode (MDE) who the investigator wishes to consider for enrollment in the study and who provide written informed consent will initially be evaluated by the Inventory of Depressive Symptomatology 30 item -Self Report (IDS-SR30) administered via Interactive Voice Response System (IVRS). Subjects who meet the minimum score of 40 on the IDS-SR30 will proceed with the remaining study related assessments at the Screening visit. Those subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one to two week Screening period to confirm eligibility and to capture Screening data prior to Randomization. At the Randomization visit, all eligibility requirements will be reconfirmed. The subjects who meet all criteria will be randomized to study medication and enter into a six-week treatment period and a subsequent one week Follow-Up period. The total duration of participation for subjects who complete all phases of the study will be approximately 8-9 weeks. During the treatment period, clinic visits will occur at Week 1, Week 2, Week 4, and Week 6. A subsequent clinic visit will occur at the end of the one week Follow-Up period. The clinical site will contact the subjects via telephone at Weeks 3 and 5 to inquire about their wellbeing, query about adverse events and administer the suicidality scale.
Eligible subjects will be randomized (1:1) to receive:
- CX157 60mg three times a day (TID) for a total daily dose of 180 mg, or
- Placebo administered three times a day.
Subjects who discontinue from the study for any reason will not be replaced.
- Conditions
- Major Depressive Disorder
- Being tested
- CX157 (TriRima), Placebo
- Keywords
- MDD
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX157 (TriRima)Drug
Six capsules administered three times a day for six weeks.
PlaceboDrug
Also called Sugar Pill
Six capsules administered three times a day for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| CX157 (TriRima) | Experimental | Not described Receives: Drug: CX157 (TriRima) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Randomization in Montgomery and Asberg Depression Rating Scale (MADRS)
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. MADRS was assessed at randomization and Weeks 1, 2, 4 and 6 of the study.
Measured: Randomization and study end (Week 6).
Secondary outcomes (6)
Montgomery and Asberg Depression Rating Scale (MADRS) Response Rate
MADRS is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. Percentage of participants who achieved a reduction in total MADRS score of at least 50% or more as compared to baseline. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Responder rate at Week 6 or the last available post treatment result (LOCF) is reported here.
Measured: Week 6 or the last available post treatment result (LOCF)
Montgomery and Asberg Depression Rating Scale (MADRS) Remitter Rate
Percentage of participants with total MADRS score of 11 or less. MADRS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. MADRS Remitter rate at Week 6 or the last available post treatment result (LOCF)is reported here.
Measured: Week 6 or the last available post treatment result (LOCF)
The Hospital Anxiety and Depression Scale (HADS)
HADS is a subject-rated questionnaire designed to detect states of anxiety and depression. The HADS consists of 14 questions relating to anxiety or depression, each with a choice of four responses [Zigmond, 1983]. These responses are numerically scored 0-3, with 0 representing the least severe response and 3 representing the most severe response. The highest possible total score is 42. HADS was assessed at randomization and Weeks 1, 2, 4, and 6 of the study. Change from randomization in the HADS total score at Week 6 or the last available post treatment result (LOCF) is reported here.
Measured: Randomization and Week 6 or the last available post treatment result (LOCF)
Inventory of Depressive Symptomatology 30 Item -Self Report (IDS -SR 30 Items)
IDSR-SR 30 measures the severity of depressive symptoms by subjects. This scale has 30 items. The minimum score is 0 and the maximum possible IDS-30 score is 90 (the highest severity). IDS-SR30 was administered at screening, randomization and Weeks 1, 2, 4, and 6. Change from randomization in the IDS-SR30 total score at Week 6 or the last available post treatment result (LOCF) is reported here.
Measured: Randomization and Week 6 or the last available post treatment result (LOCF)
Clinical Global Impression - Improvement of Illness (CGI-I)
The Clinical Global Impression - Improvement of Illness (CGI-I) was rated on a 7-point scale by the investigator to measure subject's total improvement compared to his/her condition at randomization according to the following scale: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. CGI-I was measured at Weeks 1, 2, 4 and 6. Percentage of participants "very much improved" and "much improved" at Week 6 or the last available post treatment result (LOCF) is reported here.
Measured: Week 6 or the last available post treatment result (LOCF)
Clinical Global Impression - Severity of Illness (CGI-S)
CGI-S measures the study rater's assessment of the severity of depression illness. CGI-S is rated on a scale of 1-7 as follows: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill patients. CGI-S was measured at randomization and Weeks 1, 2, 4 and 6. Percentage of subjects reported as normal, not at all ill; borderline mentally ill; and mildly ill is reported here at Week 6 or the last available post treatment result (LOCF).
Measured: Week 6 or the last available post treatment result (LOCF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- CeNeRx BioPharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Burch, MD, Study director, CeNeRx BioPharma Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739908
- Sponsor's protocol ID
- CX157-200
- Acronym
- CX157-200
- Status last verified
- Jun 2012
- First submitted
- 20 Aug 2008
- Last updated
- 27 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Targum SD. Early symptomatic improvement affects treatment outcome in a study of major depressive disorder. J Psychiatr Res. 2017 Dec;95:276-281. doi: 10.1016/j.jpsychires.2017.09.009. Epub 2017 Sep 8.
PubMed 28926793
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Parallel-Group, Assessment of the Efficacy, Safety and Tolerability of CX157 (TriRima) 60mg Three Times a Day (TID) in Subjects With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00739908
- Acronym / sponsor ID
- CX157-200 / CX157-200
- Conditions
- Major Depressive Disorder
- Keywords
- MDD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- CeNeRx BioPharma Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Posted 27 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). Secondary objectives are to evaluate the safety and tolerability and steady state pharmacokinetic profile of CX157 in these subjects.
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 conducted at approximately 12 investigative sites in the US.
Subjects with suspected Major Depressive Disorder (MDD) and experiencing a Major Depressive Episode (MDE) who the investigator wishes to consider for enrollment in the study and who provide written informed consent will initially be evaluated by the Inventory of Depressive Symptomatology 30 item -Self Report (IDS-SR30) administered via Interactive Voice Response System (IVRS). Subjects who meet the minimum score of 40 on the IDS-SR30 will proceed with the remaining study related assessments at the Screening visit. Those subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one to two week Screening period to confirm eligibility and to capture Screening data prior to Randomization. At the Randomization visit, all eligibility requirements will be reconfirmed. The subjects who meet all criteria will be randomized to study medication and enter into a six-week treatment period and a subsequent one week Follow-Up period. The total duration of participation for subjects who complete all phases of the study will be approximately 8-9 weeks. During the treatment period, clinic visits will occur at Week 1, Week 2, Week 4, and Week 6. A subsequent clinic visit will occur at the end of the one week Follow-Up period. The clinical site will contact the subjects via telephone at Weeks 3 and 5 to inquire about their wellbeing, query about adverse events and administer the suicidality scale.
Eligible subjects will be randomized (1:1) to receive:
- CX157 60mg three times a day (TID) for a total daily dose of 180 mg, or
- Placebo administered three times a day.
Subjects who discontinue from the study for any reason will not be replaced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CX157 (TriRima) | Experimental | Drug: CX157 (TriRima) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (31 listed)
- 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;
- At risk for suicide
- Lack of response to >2 trials of adequate dose \& duration of antidepressants of different mechanistic classes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CX157 (TriRima)Six capsules administered three times a day for six weeks. | Drug | CX157 (TriRima) |
| PlaceboAlso: Sugar PillSix capsules administered three times a day for six weeks. | Drug | Placebo |
Primary outcome
Change From Randomization in Montgomery and Asberg Depression Rating Scale (MADRS)
Time frame: Randomization and study end (Week 6).
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item checklist designed to measure the overall severity of depressive symptoms in patients with MDD [Montgomery, 1979]. Items are rated on a scale of 0-6, with scores ranging from 0 to 60 with 0 being symptom free and 60 being the most severe depression. MADRS was assessed at randomization and Weeks 1, 2, 4 and 6 of the study.
6 secondary outcomes
Montgomery and Asberg Depression Rating Scale (MADRS) Response Rate
Time frame: Week 6 or the last available post treatment result (LOCF)
Montgomery and Asberg Depression Rating Scale (MADRS) Remitter Rate
Time frame: Week 6 or the last available post treatment result (LOCF)
The Hospital Anxiety and Depression Scale (HADS)
Time frame: Randomization and Week 6 or the last available post treatment result (LOCF)
Inventory of Depressive Symptomatology 30 Item -Self Report (IDS -SR 30 Items)
Time frame: Randomization and Week 6 or the last available post treatment result (LOCF)
Clinical Global Impression - Improvement of Illness (CGI-I)
Time frame: Week 6 or the last available post treatment result (LOCF)
Clinical Global Impression - Severity of Illness (CGI-S)
Time frame: Week 6 or the last available post treatment result (LOCF)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28926793Targum SD. Early symptomatic improvement affects treatment outcome in a study of major depressive disorder. J Psychiatr Res. 2017 Dec;95:276-281. doi: 10.1016/j.jpsychires.2017.09.009. Epub 2017 Sep 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Burch, MD study director
CeNeRx BioPharma Inc.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CX157 (TriRima) in people with Major Depressive Disorder, run by CeNeRx BioPharma Inc. at 14 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 6 inclusion and 31 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 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Yes. Results are posted in the registry (first posted 27 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Randomization in Montgomery and Asberg Depression Rating Scale (MADRS) (time frame: Randomization and study end (Week 6).). 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 NCT00739908, which also lists 1 linked publication.
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 27 Jun 2012.