Clinical trial NCT01957410: A Study to Investigate Evoked Potentials as Markers of Ketamine-induced Cortical Plasticity in Patients With Major Depressive Disorder
Official title: An Open-Label and Double-Blind Study to Investigate Evoked Potentials as Markers of Ketamine-induced Cortical Plasticity in Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Ketamine
Evoked potentials
Somatosensory evoked potentials
Motor evoked potentials
Cortical plasticity
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study will be conducted in patients with Major Depressive Disorder (MDD) and divided into 2 sequential cohorts. Cohort 1 will be conducted in 12 patients at a single center. For each patient, there will be up to 4 sequential phases: a screening phase of up to 6 weeks, an open-label treatment phase of up to 4 weeks, an optional open-label treatment phase of up to 1 week, and a follow-up phase of up to 1 week (if applicable). Cohort 2 will be conducted in 20 patients and will be a multicenter, double-blind (neither physician nor patient knows the treatment that the patient receives), randomized (the study drug is assigned by chance), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) design. For each patient, there will be up to 4 sequential phases: a screening phase of up to 6 weeks, a double-blind treatment phase of up to 4 weeks, an optional open-label treatment phase of up to 1 week, and a follow-up phase of up to 1 week (if applicable). The total study duration for each patient will be maximally about 12 weeks. Participant safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Somatosensory Evoked Potential (SEPs) Amplitudes at 4 Hours Postdose on Day 1
timeFrame: Baseline and Day 1 (4 hours postdose)
measure: Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Motor Evoked Potential (MEPs) Amplitudes at 4 Hours Postdose on Day 1
timeFrame: Baseline and Day 1 (4 hours postdose)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
state: North Carolina
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: