- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01957410
A Study to Investigate Evoked Potentials as Markers of Ketamine-induced Cortical Plasticity in Patients With Major Depressive Disorder
December 5, 2016 updated by: Janssen Research & Development, LLC
An Open-Label and Double-Blind Study to Investigate Evoked Potentials as Markers of Ketamine-induced Cortical Plasticity in Subjects With Major Depressive Disorder
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Ketamine Intravenous (IV)
Patients will receive a single IV dose of ketamine given as a continuous infusion.
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During Cohorts 1 and 2, a single ketamine 0.5 mg/kg dose will be given as a continuous IV infusion over 40 minutes by use of an electronic syringe infusion pump.
The predefined dose and infusion rate/duration should not be adjusted.
If a patient is unable to tolerate the study medication, the infusion should be stopped.
Within 1 week of completion of the open-label treatment phase, participants can receive a single dose of ketamine 0.5 mg/kg administered as an IV infusion over 40 minutes during an optional open-label treatment phase.
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PLACEBO_COMPARATOR: Placebo Intravenous (IV)
Patients will receive a single IV dose of placebo given as a continuous infusion.
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During Cohort 2, a single placebo dose will be given as a continuous IV infusion over 40 minutes by use of an electronic syringe infusion pump.
Within 1 week of completion of the double-blind treatment phase, participants can receive a single dose of ketamine 0.5 mg/kg administered as an IV infusion over 40 minutes during an optional open-label treatment phase.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Baseline and Day 1 (4 hours postdose)
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SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve.
SEPs are read on the skull with electroencephalography (EEG).
SEPs was recorded using a 64-channel EEG system at baseline (predose) and regularly after study drug administration.
The change from baseline was calculated as post-baseline value minus baseline value for each participant.
Since the number of participants at baseline differ from the number of participants at post-baseline measure (that is [i.e.] not all baseline values are paired), the mean change is not equal to the difference between the means at the two time points.
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Baseline and Day 1 (4 hours postdose)
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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
Time Frame: Baseline and Day 1 (4 hours postdose)
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MEPs are generated when stimulation of the brain on the motor cortex (with Transcranial Magnetic Stimulation [TMS]) causes the spinal cord and peripheral muscles to produce neuroelectrical signals.
MEPs are typically measured in the hand muscles.
The Motor Evoked Response to Transcranial Magnetic Stimulation (TMS MEPs) was evaluated at baseline and regularly after study drug administration.
Intracortical inhibition and facilitation was also evaluated using TMS.
A figure-of-eight coil with external loop diameters of 9 cm was used to elicit motor responses in the contralateral first dorsal interosseus.
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Baseline and Day 1 (4 hours postdose)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (ACTUAL)
September 1, 2015
Study Completion (ACTUAL)
September 1, 2015
Study Registration Dates
First Submitted
September 30, 2013
First Submitted That Met QC Criteria
September 30, 2013
First Posted (ESTIMATE)
October 8, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
January 27, 2017
Last Update Submitted That Met QC Criteria
December 5, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- CR102607
- KETIVTRD2004 (OTHER: Janssen Research & Development, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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