Proof-of-Concept Trial of CERC-501 Augmentation of Antidepressant Therapy in Treatment-Resistant Depression

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Treatment Resistant Depression

In brief

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.

Key facts

Study ID: NCT01913535
Run by: Massachusetts General Hospital
People needed: 8
Starts: 2013-09-12
Expected to finish: 2016-01-22
Last updated by the study team: 2017-07-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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.

You may not qualify if…

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
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.

Where it is running

Rush University — Chicago, Illinois, United States
University of Kansas — Wichita, Kansas, United States
Temple University — Philadelphia, Pennsylvania, United States
Brown University-Butler Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.