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Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression

This study has been terminated.
(limited enrollment)
Sponsor:
Information provided by (Responsible Party):
James Murrough, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01309581
First received: March 2, 2011
Last updated: July 29, 2013
Last verified: July 2013

March 2, 2011
July 29, 2013
April 2010
October 2010   (final data collection date for primary outcome measure)
Hamilton Rating Scale for Depression-24 (HRSD24) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ] [ Designated as safety issue: No ]
The HDRS-24 is used to rate depressive symptoms. This instrument is considered one of the "gold standard" clinician-rated instruments for depressive symptoms. We have established procedures for the maintenance of inter-rater reliability.
Same as current
Complete list of historical versions of study NCT01309581 on ClinicalTrials.gov Archive Site
Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ] [ Designated as safety issue: No ]
The QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3. Total score ranges from 0 to 27, with ranges of 0-5 (normal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate to severe), and 21+ (severe).
  • Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ] [ Designated as safety issue: No ]
    The QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3. Total score ranges from 0 to 27, with ranges of 0-5 (normal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate to severe), and 21+ (severe).
  • Brief Psychiatric Rating Scale (BPRS) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ] [ Designated as safety issue: Yes ]
    The BPRS is used to assess acute behavioral changes during the infusions. Four key BPRS items for the positive (+) symptoms of psychosis will be used: conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content. Three items representing the negative (-) symptoms of psychosis will also be used: blunted affect, emotional withdrawal, and motor retardation.
  • Patient Rated Inventory of Side Effects (PRISE) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ] [ Designated as safety issue: Yes ]
    The PRISE assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other). Each system will score 0 to 2 based on the severity of the complaints (0 = no side effect, 1 = tolerable side effect, 2 = distressing side effect) and the total score is calculated.
  • Autobiographical Memory Interview (AMI) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ] [ Designated as safety issue: Yes ]
  • Clinician-Administered Dissociative States Scale (CADSS) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ] [ Designated as safety issue: Yes ]
    The CADSS is used to measure dissociative effects during the infusions. The scale includes 19 questions and 8 observer ratings scored from 0 (not at all) to 4 (extremely). The CADSS measures impairment in body perception, environmental perception, time perception, memory impairment, and feelings of unreality.
  • The Rey Auditory Verbal Learning Test (AVLT) [ Time Frame: Change from beginning of ECT treatment to end; on average 3 weeks ] [ Designated as safety issue: Yes ]
    This scale is brief and easy to administer and has been well-validated. Equivalent alternate forms are available
Not Provided
Not Provided
 
Use of Ketamine to Enhance Electroconvulsive Therapy (ECT) in Depression
Ketamine Anesthesia to Enhance Efficacy and Tolerability of Electroconvulsive Therapy in Patients With Unipolar or Bipolar Depression

The primary objectives of this study are to investigate the potential for ketamine anesthesia to increase the antidepressant efficacy of Electroconvulsive therapy (ECT) and to decrease acute ECT-induced adverse cognitive effects.

Electroconvulsive therapy (ECT) is one of the most robust antidepressant treatments available. However, there is the potential for significant acute and longer term adverse cognitive effects with ECT and the antidepressant response requires multiple treatment sessions, increasing risk of adverse effects. Further, antidepressant response to ECT is often less than maximal and relapse is common. Growing preclinical and clinical evidence of the rapid-acting antidepressant properties of the anesthetic agent ketamine suggests the use of ketamine anesthesia as a strategy to increase rate of response and shorten treatment course in the administration of ECT. In addition, preclinical and clinical evidence suggests the potential of ketamine to decrease the adverse cognitive effects associated with ECT.

The investigators propose a pilot study to measure both acute therapeutic efficacy and cognitive side effects of ECT using ketamine compared to methohexital in depressed patients. The investigators will also explore other parameters of ECT such as seizure duration and morphology, as well as hemodynamic and behavioral changes.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Major Depression
  • Bipolar Depression
  • Drug: Ketamine
    Ketamine 1-2 mg/kg IV as indicated for ECT
  • Drug: Methohexital
    Methohexital 1 mg/kg IV as indicated for ECT
  • Experimental: Ketamine
    Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
    Intervention: Drug: Ketamine
  • Active Comparator: Methohexital
    Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
    Intervention: Drug: Methohexital
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female patients: 18 to 59 years
  2. Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study
  3. DSM IV MINI diagnosis of major depressive episode (MDD), unipolar or bipolar
  4. Pretreatment 24-item Hamilton Rating Scale for Depression score > 21
  5. ECT is clinically indicated
  6. Patient has the capacity to provide informed consent.

Exclusion Criteria:

  1. DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or mental retardation
  2. Current primary diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression
  3. Current diagnosis of delirium, dementia, or amnestic disorder
  4. Baseline Mini Mental State Exam (MMSE) score < 24 and a total score falling two standard deviations below the age- and education-adjusted mean
  5. Any active general medical condition or CNS disease which can affect cognition or response to treatment
  6. Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week
  7. Lifetime history of ketamine or PCP abuse or dependence
  8. ECT within three months
  9. The presence of any known or suspected contraindication to methohexital or ketamine including but not limited to known allergic reactions to these agents, uncontrolled hypertension arrhythmia severe coronary artery disease and porphyria
  10. Pregnancy
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01309581
GCO 09-2251, KETECT-MSSM-01
Yes
James Murrough, Mount Sinai School of Medicine
James Murrough
Not Provided
Principal Investigator: James W Murrough, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP