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A Study to Investigate Evoked Potentials as Markers of Ketamine-induced Cortical Plasticity in Patients With Major Depressive Disorder

Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Ketamine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Janssen Research & Development, LLC

Official(s) and/or principal investigator(s):
Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Comparison of change from baseline to 4 hr post-dose on Day 1 in somatosensory evoked potential amplitudes (SEPs) between ketamine responders and ketamine non-responders.

Comparison of change from baseline to 4 hr post-dose on Day 1 in motor evoked potential amplitudes (MEPs) between ketamine responders and ketamine 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

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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

Locations and Contacts

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: JNJ.CT@sylogent.com

Durham, North Carolina, United States; Recruiting
Additional Information

To learn how to participate in this trial please click here.

Starting date: February 2014
Last updated: August 7, 2015

Page last updated: August 23, 2015

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