Treatment Resistant DepressionPhase 2RAPID KORNCT01913535
Proof-of-Concept Trial of CERC-501 Augmentation of Antidepressant Therapy in Treatment-Resistant Depression
A Phase 2 study testing CERC-501 in people with Treatment Resistant Depression, run by Massachusetts General Hospital at 4 sites in United States.
Trial summary
This study is looking at the efficacy, rapidity, safety, and tolerability of two doses of oral CERC-501 for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- CERC-501
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Sep 2013to 22 Jan 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18-65 years old.
- Able to read, understand, and provide written, dated informed consent prior to screening.
- Diagnosed with Major Depressive Disorder (MDD), single or recurrent, and currently experiencing a Major Depressive Episode (MDE) of at least eight weeks in duration, prior to screening.
- Has a history of treatment resistance during the current MDE.
- Meet the threshold on the total MADRS score of greater than or equal to 20 at both screening and baseline visits, as confirmed by the remote centralized MGH CTNI rater between the screen visit and the baseline visit.
- In good general health
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- For female participants, status of non-childbearing potential or use of an acceptable form of birth control
- Body mass index between 18-40 kg/m2
- Concurrent psychotherapy will be allowed if the type and frequency of the therapy has been stable for at least three months prior to screening and is expected to remain stable during participation in the study
- Concurrent benzodiazepine and hypnotic therapy will be allowed if the therapy has been stable for at least 4 weeks prior to screening and if it is expected to remain stable during the course of the subject's participation in the study.
Who cannot join
- Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study
- Female that is pregnant or breastfeeding
- Female with a positive pregnancy test at screening or baseline
- History during the current MDE of failure to achieve a satisfactory response to >3 treatment courses of a therapeutic dose of an antidepressant therapy of at least 8 weeks duration during the current episode
- Total MADRS score of <20 at the screen or baseline visits, or as assessed by the remote, independent MGH CTNI rater and reported to the site
- Current diagnosis of a Substance Use Disorder (Abuse or Dependence) with the exception of nicotine dependence, at screening or within six months prior to screening
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- Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder or Specific Phobia (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past 6 months or more)
- History of bipolar disorder, schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes
- History of eating disorders within five years of screening
- Any Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant at any time within 6 months prior to screening
- Subject is considered at significant risk for suicidal behavior during the course of their participation in the study
- Subject has had electroconvulsive therapy in the current episode of depression
- Has received vagus nerve stimulation (VNS) at any time prior to screening
- Dementia, delirium, amnestic, or any other cognitive disorder
- Has a clinically significant abnormality on the screening physical examination
- Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation
- Known history or current episode of: Uncontrolled hypertension, Recent myocardial infarction (within one year) or a history of more than one myocardial infarction, Syncopal event within the past year, Congestive heart failure, Angina pectoris, Systolic BP <85 or >160 mmHg or diastolic BP >95 mmHg or heart rate <50 or >105 beats per minute at screening or randomization, or QTcF greater than or equal to 450 msec at screening or randomization.
- Chronic lung disease
- Lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system disorder, epilepsy, mental retardation, or any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system, or a history of significant head trauma within the past 2 years
- Presents with a history of Thyroid stimulating hormone outside of the normal limits and clinically significant as determined by the investigator
- Patients with diabetes mellitus fulfilling any of the following criteria:
- Unstable diabetes mellitus defined as glycosylated hemoglobin (HbA1c) >8.5% at screening
- Admitted to hospital for treatment of diabetes mellitus or diabetes mellitus related illness in the past 12 weeks
- Not under physician care for diabetes mellitus
- Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to screening. For thiazolidinediones (glitazones) this period should not be less than 8 weeks.
- Any other clinically significant abnormal laboratory result (as determined after evaluation by study investigator and MGH CTNI medical monitor) at the time of the screening exam.
- History of hypothyroidism and has been on a stable dosage of thyroid replacement medication, or was surgically treated less than six months prior to screening
- History of hyperthyroidism which was treated (medically or surgically) less than six months prior to screening
- Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with the interpretation of study results
- History of positive screening urine test for drugs of abuse
- Patients with exclusionary laboratory values, or requiring treatment with exclusionary concomitant medications, including tricyclic antidepressants and monoamine oxidase inhibitors, or on two or more concomitant antidepressant therapies
- Patients currently taking a proton pump inhibitor (PPI)/histamine 2 (H2) blocker or with a history of chronic NSAID use
- Patients with a positive test for Helicobacter pylori (urea breath test)
- Patients with any of the following GI-related findings:
- Clinically evident GI complaints or GI disease at Screening or Visit 1
- Past history of gastric disease (including but not limited to peptic ulcer disease, gastritis (including atrophic gastritis), upper GI bleeding, any other GI precancerous conditions), and of any other clinically relevant GI disease.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rush University
Chicago, Illinois
Temple University
Philadelphia, Pennsylvania
Brown University-Butler Hospital
Providence, Rhode Island
University of Kansas
Wichita, Kansas
About this study
Official title: Double-Blind, Placebo-Controlled, Proof-of-Concept (POC) Trial of CERC-501, a Kappa-Selective Opioid Receptor Antagonist, Augmentation of Antidepressant Therapy in Treatment-Resistant Depression (TRD)
This study is looking at the efficacy, rapidity, safety, and tolerability of two doses of oral CERC-501 for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.
Read the detailed description
This study will involve 10 visits to the clinical site over approximately 1.5 months. There will be a screening visit (7-28 days may pass between the screening visit and the first treatment visit), a baseline/treatment visit (first day of study drug treatment), followed by 5 consecutive days of treatment visits. Follow-up visits will occur 6, 13, and 20 days after first receiving study drug.
- Conditions
- Treatment Resistant Depression
- Being tested
- CERC-501, Placebo
- Keywords
- Depression, Treatment Resistant Depression, Antidepressant, Major Depression, MDD
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CERC-501Drug
Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).
High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).
For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.
For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days.
PlaceboDrug
For patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days).
For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.
For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Drug-Drug Arm | Active comparator | Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2) Receives: Drug: CERC-501 |
| High Dose Drug-Drug Arm | Active comparator | Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2) Receives: Drug: CERC-501 |
| Placebo/Low-Dose Drug Arm | Other | Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2) Receives: Drug: CERC-501; Drug: Placebo |
| Placebo/High-Dose Drug Arm | Other | Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2) Receives: Drug: CERC-501; Drug: Placebo |
| Placebo/Placebo Arm | Placebo comparator | Patients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)
This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms. Total scores range from 0 (normal) to 22 (severe).
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Measured: Baseline and 72 hours after initiating treatment
Secondary outcomes (12)
Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6), Day 20
This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms. Total scores range from 0 (normal) to 22 (severe).
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Measured: Baseline and 20 days after initiating treatment
Number of Participants With Response on Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)
Compare response rates at 72 hours for of patients treated with either dose (10 mg/day or 20 mg/day) of CERC-501 to those assigned to placebo therapy, using the Sequential Parallel Comparison Design (SPCD), with response defined as a 50% or greater reduction from baseline to Day 3 on the HAM-D-6 total score).
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
The HAM-D-6 instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms.
Measured: 72 hours after treatment initiation
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity (in past 3 days), was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression.
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Measured: Baseline and 72 hours and 20 days after initiating treatment
Change in Clinical Global Impression -Severity (CGI-S)
The CGI-S scale was administered by clinicians to measure depressive severity (CGI-S). Each item is rated on a seven-point scale (1=normal to 7=among the most severe), so a higher total score indicates greater depressive severity. Severity is assessed based on the last 24 hours.
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Measured: Baseline and 72 hours and 20 days after initiating treatment
Clinical Global Impression-Improvement (CGI-I)
The CGI-I scale was administered by clinicians to measure improvement in depressive severity (CGI-I). Each item is rated on a seven-point scale (1=very much improved to 7=very much worse), so a higher total score indicates less improvement in depressive severity. Improvement is assessed based on the last 24 hours.
Measured: 72 hours and 20 days after initiating treatment
Change in Symptoms of Depression Questionnaire (SDQ)
This validated self-rating instrument has 44 items on a scale of 1-6, measuring multiple depressive symptom domains. Each item is rated based on a subject's perception of what is normal for the individual (score = 2), what is better than normal (score = 1), and what is worse than normal (scores = 3-6). This scale is rated based on the past 24 hours. A total score is calculated by summing the 44 item scores, for a range of 0-264.
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Measured: Baseline and 72 hours and 20 days after initiating treatment
Change in Perceived Stress Scale (PSS)
This is a 10-item, validated, self-rated measure of perceived stress, that is of the degree to which the subjects perceives things to be stressful and overwhelming. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. This scale is rated based on the past 24 hours.
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Measured: Baseline and 72 hours and 20 days after treatment initiation
Change in Positive Affect Scale (PAS)
This is a validated, self-rated measure of positive affect uses 5-point scales (1 = very slightly/not at all to 5 = extremely). Higher scores represent higher levels of positive affect. The scale is rated based on the past 24 hours. The total score is the sum of 10 items, for a range of 10-50.
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Measured: Baseline and 72 hours and 20 days after initiating treatment
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction With Participation in Social Roles and Discretionary Activities
These are two well-validated 7-item self-rating scales that measure social health. A higher score represents higher satisfaction on each scale. The scales are rated based on the past 24 hours. Each item is rated 1-5 (1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much). Each 7-item subscale score is the sum of each of the 7 items and ranges from 7-35.
To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
Measured: Baseline and 72 hours and 20 days after initiating treatment
Change in the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior. It is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the level and type of suicidality present. The C-SSRS will be performed to assess suicidal ideation and behavior. It contains a 5-item rating scale for suicidal ideation and a 7-item rating scale for suicidal behavior. Higher total scores indicate higher severity. Each item is coded 1=yes, 0=no, so a total score of 0 on each scale means that a no response was entered for each of the 5 suicidal ideation and for each of the 7 suicidal behavior questions, i.e., 0=lowest severity score. Total suicidal ideation score ranges from 0 (least severe) to 5 (most severe). Total suicidal behavior score ranges from 0 (least severe) to 7 (most severe).
Measured: Baseline and 72 hours after initiating treatment
Number of Participants With Clinically Significant Abnormal ECG
Number of Participants with clinically significant abnormal electrocardiogram (ECG)
Measured: 72 hours after treatment initiation
Number of Participants With Clinically Significant Abnormal Labs
Total number of participants with clinically significant abnormal labs
Measured: 72 hours after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study start12 Sep 2013
- Primary completion22 Jan 2016
- Study completion22 Jan 2016
Why it stopped: slow enrollment
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.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Model description
- sequential parallel comparison design (SPCD) with two phases
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Butler Hospital, Rush University, Temple University, University of Kansas
- Responsible party
- Principal investigator, Maurizio Fava, MD, Massachusetts General Hospital
- Investigators
- Maurizio Fava, MD, Principal investigator, Massachusetts General Hospital (Coordinating Center)Linda L Carpenter, MD, Principal investigator, Brown University-Butler HospitalJohn Zajecka, MD, Principal investigator, Rush UniversityMary F Morrison, MD, Principal investigator, Temple UniversityMatthew Macaluso, DO, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913535
- Sponsor's protocol ID
- RAP-002
- Other IDs
- 271201100006I-0-27100007-1
- Acronym
- RAPID KOR
- Status last verified
- May 2017
- First submitted
- 30 Jul 2013
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Proof-of-Concept (POC) Trial of CERC-501, a Kappa-Selective Opioid Receptor Antagonist, Augmentation of Antidepressant Therapy in Treatment-Resistant Depression (TRD)
- ClinicalTrials.gov ID
- NCT01913535
- Acronym / sponsor ID
- RAPID KOR / RAP-002
- Conditions
- Treatment Resistant Depression
- Keywords
- Depression, Treatment Resistant Depression, Antidepressant, Major Depression, MDD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Butler Hospital, Rush University, Temple University, University of Kansas
- Study start
- 12 Sep 2013 (actual)
- Primary completion
- 22 Jan 2016 (actual)
- Study completion
- 22 Jan 2016 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is looking at the efficacy, rapidity, safety, and tolerability of two doses of oral CERC-501 for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.
Detailed description
This study will involve 10 visits to the clinical site over approximately 1.5 months. There will be a screening visit (7-28 days may pass between the screening visit and the first treatment visit), a baseline/treatment visit (first day of study drug treatment), followed by 5 consecutive days of treatment visits. Follow-up visits will occur 6, 13, and 20 days after first receiving study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- sequential parallel comparison design (SPCD) with two phases
| Arm | Type | Receives |
|---|---|---|
| Low Dose Drug-Drug Arm | Active comparator | Drug: CERC-501Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2) |
| High Dose Drug-Drug Arm | Active comparator | Drug: CERC-501Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2) |
| Placebo/Low-Dose Drug Arm | Other | Drug: CERC-501, Drug: PlaceboPatients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2) |
| Placebo/High-Dose Drug Arm | Other | Drug: CERC-501, Drug: PlaceboPatients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2) |
| Placebo/Placebo Arm | Placebo comparator | Drug: PlaceboPatients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, 18-65 years old.
- Able to read, understand, and provide written, dated informed consent prior to screening.
- Diagnosed with Major Depressive Disorder (MDD), single or recurrent, and currently experiencing a Major Depressive Episode (MDE) of at least eight weeks in duration, prior to screening.
- Has a history of treatment resistance during the current MDE.
- Meet the threshold on the total MADRS score of greater than or equal to 20 at both screening and baseline visits, as confirmed by the remote centralized MGH CTNI rater between the screen visit and the baseline visit.
Key exclusion criteria (36 listed)
- Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study
- Female that is pregnant or breastfeeding
- Female with a positive pregnancy test at screening or baseline
- History during the current MDE of failure to achieve a satisfactory response to >3 treatment courses of a therapeutic dose of an antidepressant therapy of at least 8 weeks duration during the current episode
- Total MADRS score of <20 at the screen or baseline visits, or as assessed by the remote, independent MGH CTNI rater and reported to the site
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-501Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days). High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days). For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days. For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days. | Drug | High Dose Drug-Drug Arm, Low Dose Drug-Drug Arm, Placebo/High-Dose Drug Arm, Placebo/Low-Dose Drug Arm |
| PlaceboFor patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days). For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days. For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days. | Drug | Placebo/High-Dose Drug Arm, Placebo/Low-Dose Drug Arm, Placebo/Placebo Arm |
Primary outcome
Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)
Time frame: Baseline and 72 hours after initiating treatment
This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms. Total scores range from 0 (normal) to 22 (severe). To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.
12 secondary outcomes
Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6), Day 20
Time frame: Baseline and 20 days after initiating treatment
Number of Participants With Response on Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)
Time frame: 72 hours after treatment initiation
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline and 72 hours and 20 days after initiating treatment
Change in Clinical Global Impression -Severity (CGI-S)
Time frame: Baseline and 72 hours and 20 days after initiating treatment
Clinical Global Impression-Improvement (CGI-I)
Time frame: 72 hours and 20 days after initiating treatment
Change in Symptoms of Depression Questionnaire (SDQ)
Time frame: Baseline and 72 hours and 20 days after initiating treatment
Change in Perceived Stress Scale (PSS)
Time frame: Baseline and 72 hours and 20 days after treatment initiation
Change in Positive Affect Scale (PAS)
Time frame: Baseline and 72 hours and 20 days after initiating treatment
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction With Participation in Social Roles and Discretionary Activities
Time frame: Baseline and 72 hours and 20 days after initiating treatment
Change in the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline and 72 hours after initiating treatment
Number of Participants With Clinically Significant Abnormal ECG
Time frame: 72 hours after treatment initiation
Number of Participants With Clinically Significant Abnormal Labs
Time frame: 72 hours after treatment initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Maurizio Fava, MD principal investigator
Massachusetts General Hospital (Coordinating Center)
Linda L Carpenter, MD principal investigator
Brown University-Butler Hospital
John Zajecka, MD principal investigator
Rush University
4 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-501 in people with Treatment Resistant Depression, run by Massachusetts General Hospital at 4 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 10 inclusion and 36 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: stopped early, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 2 Jul 2017). 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 in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6) (time frame: Baseline and 72 hours after initiating treatment). 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 2 Jul 2017.