Major Depressive DisorderPhase 2NCT01941043
A Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Study of CERC-301 in the Adjunctive Treatment of Subjects With Severe Depression and Recent Active Suicidal Ideation Despite Antidepressant Treatment
A Phase 2 study testing CERC-301 in people with Major Depressive Disorder, run by Avalo Therapeutics, Inc. at 24 sites in United States.
Trial summary
The current study will evaluate the antidepressant effect of CERC-301 during 28 days of treatment in subjects with MDD who are currently experiencing a severe depressive episode despite stable ongoing treatment with selective serotonin- or serotonin-norepinephrine reuptake inhibitors (SSRI or SNRI). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- CERC-301
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,357 participants
- Where
- 24 sitesUnited States
- Study dates
- Nov 2013to Oct 2014
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 to 70 years of age inclusive.
- Females must be either:
- Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or-
- Women of childbearing potential (WOCBP) meeting the criteria below:
- Uses an acceptable double-barrier method of contraception as determined by the Investigator -and- ii. Is not lactating, has a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test prior to randomization on Day 0.
- Male subjects must agree to use a condom if partner is of childbearing potential.
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- Diagnosis of MDD recurrent without psychotic features according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria with diagnosis confirmed using the Structured Clinical Interview for DSM-IV Axis I Disorders Clinical Trials Version (SCID-CT).
- Currently adhering to antidepressant drug regimen that consists of stable SSRI or SNRI therapy
- Inadequate antidepressant response to current antidepressant therapy despite adequate dose and duration
- HDRS-17 score ≥ 21 on the HDRS-17 performed by the site at screening
- Recent active suicidal ideation defined as a score of 2 on the intensity of ideation section on the Columbia-Suicide Severity Rating Scale (C-SSRS) during the four weeks prior to screening using the "Baseline/Screening" version of the C-SSRS.
- In otherwise good general health without any unstable medical conditions (as determined by medical history, physical examination, 12-lead ECG, clinical laboratory testing, etc.).
Who cannot join
- History of substance abuse or dependence within the 3 months prior to screening.
- Positive urine drug test at screening and prior to randomization on Day 0 unless due to a permitted medication that is documented in the subject's medication history.
- Positive ethanol breath test at screening and/or prior to randomization on Day 0.
- Elevated semi-recumbent blood pressure at screening and prior to randomization on Day 0, defined as systolic blood pressure > 140 mm Hg and diastolic blood pressure
- Active, comorbid disease that might limit the ability of the subject to participate in the study as determined by the Investigator (i.e. poorly controlled diabetes mellitus, unstable angina, coronary artery disease, congestive heart failure, etc.).
- Subjects with clinical laboratory test abnormality deemed clinically significant by the Investigator at screening.
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- Axis I diagnosis of obsessive compulsive disorder, posttraumatic stress disorder, bipolar I or II mood disorders, eating disorders (e.g., anorexia nervosa, bulimia nervosa), psychotic disorders (e.g., schizoaffective disorder, schizophrenia), significant cognitive disorders (e.g., delirium, dementia, amnesia), or dissociative disorders.
- Subjects with Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder.
- Subjects with a neurologic disorder that could cause or contribute to depression (e.g., Alzheimer's disease, Parkinson's disease).
- Female subjects currently experiencing postpartum depression.
- Subjects who, in the opinion of the Investigator, are not appropriate for a 35-day placebo-controlled study due to risk of significant threat to self or others during screening or study conduct.
- Use of other NMDA-receptor modulators (e.g., dextromethorphan, ketamine, amantadine, memantine) within 30 days of screening and throughout the study.
- The following concomitant medication use is excluded within six weeks prior to screening:
- Bupropion or tricyclic antidepressants
- Intermittent, symptomatic use of benzodiazepines (e.g. symptomatic treatment of anxiety or panic attacks)
- Antipsychotics
- Lithium
- Any medications known to directly interact with central or peripheral serotonergic receptors, other than the permitted antidepressants.
- Any medications known to directly interact with central noradrenergic receptors, other than the permitted antidepressants.
- Electroconvulsive therapy, transcranial magnetic stimulation, or vagal nerve stimulation during the current depressive episode.
- Participation in an investigational drug or device study within the 6 months prior to screening.
- Subjects with suicidal behavior within 6 months prior to screening as measured by the C-SSRS "Baseline/Screening" version.
- Subjects with a C-SSRS score > 2 on the intensity of ideation section at randomization (Visit 2a), using the "Since Last Visit" version of the C-SSRS.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Sheppard Pratt Health System
Baltimore, Maryland, 21285
Northwest Clinical Research Center
Bellevue, Washington, 98007
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, 44718
Chicago Psychiatry Associates
Chicago, Illinois, 60602
ProScience Research Group
Culver City, California, 90230
FutureSearch Trials of Dallas
Dallas, Texas, 75231
Collaborative NeuroScience Network, Inc.
Garden Grove, California, 92845
Behavioral Research Specialists
Glendale, California, 91206
Clinical Neuroscience Solutions
Jacksonville, Florida, 32256
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Suburban Research Associates
Media, Pennsylvania, 19063
Bioscience Research
Mount Kisco, New York, 10549
Synergy Clinical Research Center
National City, California, 91950
The Medical Research Network
New York, New York, 10128
Scientific Clinical Research, Inc.
North Miami, Florida, 33161
PCRC
O'Fallon, Missouri, 63368
Pacific Clinical Trials, LLC
Oakland, California, 94612
Southern CA Psychiatrists
Oceanside, California, 92056
Clinical Neuroscience Solutions
Orlando, Florida, 32806
Arizona TMS Therapy Center
Phoenix, Arizona, 85032
Finger Lakes Clinical Research
Rochester, New York, 14618
Artemis Institute for Clinical Research
San Diego, California, 92123
About this study
The current study will evaluate the antidepressant effect of CERC-301 during 28 days of treatment in subjects with MDD who are currently experiencing a severe depressive episode despite stable ongoing treatment with selective serotonin- or serotonin-norepinephrine reuptake inhibitors (SSRI or SNRI). The study population will be enriched for subjects that would benefit most from rapid onset, those with recent active suicidal ideation, but not a risk to themselves or others and are deemed appropriate for an out-patient study with careful safety surveillance. This will allow the study to focus on the antidepressant effects of CERC-301 but also explore effects on suicidal ideation. To explore rapid onset, the primary endpoint will be at 7 days, but effects over the 28 days of treatment will be examined as a secondary endpoint.
- Conditions
- Major Depressive Disorder
- Being tested
- CERC-301, Placebo
- 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.
CERC-301Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| CERC-301, Treatment Sequence 1 | Experimental | Treatment Sequence 1 - 7 days on placebo and 28 days on study drug (either 12mg or 8mg) Receives: Drug: CERC-301; Other: Placebo |
| CERC-301, Treatment Sequence 2 | Experimental | Treatment Sequence 2 - Placebo for 7 days and study drug for 28 days (8 mgs) Receives: Drug: CERC-301; Other: Placebo |
| Placebo, Treatment Sequence 3 | Placebo comparator | Treatment Sequence 3 - Placebo for 35 Day treatment period Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDRS-17 after 7 days of dosing with study drug
The overall between-treatment difference will be computed as the weighted average of the differences (drug vs. placebo)
Measured: Screening & Days 0, 4, 7, 11, 14, 21,28, & 35
Secondary outcomes (2)
HDRS-17 Averaged between 7 and 28 days of treatment with study drug
This will be analyzed using the mixed effects model for repeated measures. The between-group (drug vs. placebo) differences will be estimated by the least squares mean for the contrast in the main effect.
Measured: Screening, Days 0, 4, 7, 11, 14, 21, 28, & 35
HDRS-17 after 28 days of dosing with study drug
This will be analyzed using the mixed effects model for repeated measures . The between-group difference will be estimates by the least squares mean difference at Day 28 as a simple contrast from the model.
Measured: Screening, Days 0, 4, 7, 11, 14, 21, 28, 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avalo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Vornov, MD, PhD, Study director, Avalo Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941043
- Sponsor's protocol ID
- Clin301-201
- Status last verified
- Dec 2017
- First submitted
- 5 Sep 2013
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Study of CERC-301 in the Adjunctive Treatment of Subjects With Severe Depression and Recent Active Suicidal Ideation Despite Antidepressant Treatment
- ClinicalTrials.gov ID
- NCT01941043
- Acronym / sponsor ID
- Clin301-201
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,357 participants (actual)
- Lead sponsor
- Avalo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study will evaluate the antidepressant effect of CERC-301 during 28 days of treatment in subjects with MDD who are currently experiencing a severe depressive episode despite stable ongoing treatment with selective serotonin- or serotonin-norepinephrine reuptake inhibitors (SSRI or SNRI). The study population will be enriched for subjects that would benefit most from rapid onset, those with recent active suicidal ideation, but not a risk to themselves or others and are deemed appropriate for an out-patient study with careful safety surveillance. This will allow the study to focus on the antidepressant effects of CERC-301 but also explore effects on suicidal ideation. To explore rapid onset, the primary endpoint will be at 7 days, but effects over the 28 days of treatment will be examined as a secondary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CERC-301, Treatment Sequence 1 | Experimental | Drug: CERC-301, Other: PlaceboTreatment Sequence 1 - 7 days on placebo and 28 days on study drug (either 12mg or 8mg) |
| CERC-301, Treatment Sequence 2 | Experimental | Drug: CERC-301, Other: PlaceboTreatment Sequence 2 - Placebo for 7 days and study drug for 28 days (8 mgs) |
| Placebo, Treatment Sequence 3 | Placebo comparator | Other: PlaceboTreatment Sequence 3 - Placebo for 35 Day treatment period |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female 18 to 70 years of age inclusive.
- Females must be either:
- Male subjects must agree to use a condom if partner is of childbearing potential.
- Diagnosis of MDD recurrent without psychotic features according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria with diagnosis confirmed using the Structured Clinical Interview for DSM-IV Axis I Disorders Clinical Trials Version (SCID-CT).
- Currently adhering to antidepressant drug regimen that consists of stable SSRI or SNRI therapy
Key exclusion criteria (23 listed)
- History of substance abuse or dependence within the 3 months prior to screening.
- Positive urine drug test at screening and prior to randomization on Day 0 unless due to a permitted medication that is documented in the subject's medication history.
- Positive ethanol breath test at screening and/or prior to randomization on Day 0.
- Elevated semi-recumbent blood pressure at screening and prior to randomization on Day 0, defined as systolic blood pressure > 140 mm Hg and diastolic blood pressure
- Active, comorbid disease that might limit the ability of the subject to participate in the study as determined by the Investigator (i.e. poorly controlled diabetes mellitus, unstable angina, coronary artery disease, congestive heart failure, etc.).
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 |
|---|---|---|
| CERC-301 | Drug | CERC-301, Treatment Sequence 1, CERC-301, Treatment Sequence 2 |
| Placebo | Other | CERC-301, Treatment Sequence 1, CERC-301, Treatment Sequence 2, Placebo, Treatment Sequence 3 |
Primary outcome
HDRS-17 after 7 days of dosing with study drug
Time frame: Screening & Days 0, 4, 7, 11, 14, 21,28, & 35
The overall between-treatment difference will be computed as the weighted average of the differences (drug vs. placebo)
2 secondary outcomes
HDRS-17 Averaged between 7 and 28 days of treatment with study drug
Time frame: Screening, Days 0, 4, 7, 11, 14, 21, 28, & 35
HDRS-17 after 28 days of dosing with study drug
Time frame: Screening, Days 0, 4, 7, 11, 14, 21, 28, 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
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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.
James Vornov, MD, PhD study director
Avalo Therapeutics, Inc.
24 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 CERC-301 in people with Major Depressive Disorder, run by Avalo Therapeutics, Inc. at 24 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 12 inclusion and 23 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 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
HDRS-17 after 7 days of dosing with study drug (time frame: Screening & Days 0, 4, 7, 11, 14, 21,28, & 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2017; AzTrials last refreshed its copy on 26 Oct 2026.