A Study to Investigate Evoked Potentials as Markers of Ketamine-induced Cortical Plasticity in Patients With Major Depressive Disorder
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Major Depressive Disorder
In brief
To evaluate if somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) obtained with electroencephalography (EEG) and electromyography (EMG) can be used to detect changes in cortical plasticity in responders to a single IV infusion of ketamine as compared to non-responders.
Key facts
- Study ID
- NCT01957410
- Run by
- Janssen Research & Development, LLC
- People needed
- 13
- Starts
- 2014-02-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2017-01-27
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient must be medically stable
- Patient must meet Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Mini International Psychiatric Interview (MINI)
- Patient must have had an inadequate response to at least 2 antidepressants, one of which is in the current episode of depression
- Patient must have an Inventory of Depressive Symptomatology 30-item Clinician-rated (IDS-C30) total score ≥ 34 at Screening and Day -1
- Women must be postmenopausal, surgically sterile, or, if heterosexually active, practicing a highly effective method of birth control
- Men who are heterosexually active with a woman of childbearing potential must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
You may not qualify if…
- Patient has current signs and/or symptoms of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbances
- Patient has a primary DSM-IV diagnosis of current (active) generalized anxiety disorder (GAD), panic disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD), anorexia nervosa, or bulimia nervosa
- Patient has a current diagnosis of bipolar disorder, mental retardation, or cluster b personality disorder (e.g., borderline personality disorders, antisocial personality disorder, etc)
- Patient has a current or prior diagnosis of a psychotic disorder or MDD with psychosis
- Patient has not responded to treatment with electroconvulsive therapy (ECT) in the current episode of depression
- Patient has suicidal ideation with intent to act, or has homicidal ideation/intent, during Screening phase per Investigator's clinical judgment
- Patient has any significant primary sleep disorder
Where it is running
- Study site — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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