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Ketamine as an Alternative Treatment to ECT in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT02659085
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Pouya Movahed Rad, Region Skane

Brief Summary:
Developing more effective and faster acting antidepressant is of outmost clinical importance. Available antidepressant therapies have a delayed therapeutic effect. It typically takes several weeks before symptom relief is evident. Furthermore, antidepressants are relatively ineffective - as many as 30% of patients do not respond to any medication at all. In this study the investigators evaluate the NMDA-receptor antagonist ketamine as a potentially new antidepressant treatment for severely depressed patients and compare its effectiveness with that of electroconvulsive therapy (ECT).

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Ketamine IV Infusion Procedure: ECT Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Non-inferiority Trial Comparing Ketamine With ECT in Patients With Major Depressive Disorder
Study Start Date : February 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Electroconvulsive Therapy (ECT)
ECT given in line with standard procedures (including anesthesia, muscle relaxation and oxygenation) thrice weekly. Each participating clinic decides for each patient whether the treatment is given uni- or bilateral, as well as the exact stimulation parameters. Choice of anesthetic drug (e.g. thiopental of propofol) and muscle relaxant is done by local anesthesiologist. The procedure differs in no way from how a given patient would have been treated if he or she were not included in the study.
Procedure: ECT
ECT given in line with standard procedures (including anesthesia, muscle relaxation and oxygenation) thrice weekly.

Experimental: Ketamine IV Infusion
Ketamin intra venous infusions of racemic ketamine (0.5mg/kg), delivered over a period of 40 minutes thrice weekly, as ECT (Monday, Wednesday and Friday).
Drug: Ketamine IV Infusion
Patients randomized to the experimental treatment receive intravenous infusions of racemic ketamine (0.5 mg/kg), delivered over a period of forty minutes thrice weekly (Monday, Wednesday, Friday) under supervision.
Other Name: Ketamine




Primary Outcome Measures :
  1. Proportion of patients in remission in each treatment arm assessed by Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Follow up of one year after treatment cessation ]
    Primary outcome is the proportion of patients in remission in each treatment arm. Remission is defined as a MADRS ≤ 10.


Secondary Outcome Measures :
  1. Time to remission compared between the two treatments. [ Time Frame: The MADRS score is measured for a maximum of 4 weeks. ]
    Time (days) to reach remission (defined as MADRS≤ 10) is compared between the groups.

  2. Time to response compared between the two treatments. [ Time Frame: The MADRS score is measured for a maximum of 4 weeks. ]
    Time (days) to response (defined as a drop of 50% from the pre-treatment MADRS value)) is compared between the groups.

  3. Ketamine treatment is associated with a smaller decrease in the performance in a CANTAB cognitive test battery compared to ECT. [ Time Frame: Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment. ]
    Cognitive function are assessed with Cambridge Automated Neuropsychological Test Automated Battery (CANTAB).

  4. Remission from severe depression is associated with improved performance in the performance in a CANTAB cognitive test battery. [ Time Frame: Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment. ]
    Cognitive function are assessed with Cambridge Automated Neuropsychological Test Automated Battery (CANTAB).

  5. The antidepressant effect of ketamine is longer lasting than that of ECT, assessed by the proportion of patients in remission (defined by a maximum score of 9 in the Montgomery-Asberg Depression Rating Scale (MADRS)). [ Time Frame: Within one week after remission and at three additional time points (3, 6 and 12 months) after remission ]
    The antidepressant effect will be assessed with MADRS baseline score and measured within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment.

  6. Ketamine treatment is associated with a smaller decrease in the performance in Rey Auditory Verbal Learning Test (RAVLT) compared to ECT. [ Time Frame: Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment. ]
    Reys Auditory Verbal Learning Test (RAVLT)

  7. Remission from severe depression is associated with improved performance in the performance in Rey Auditory Verbal Learning Test (RAVLT). [ Time Frame: Assessed prior to the first treatment, after two weeks, within one week after remission and at three additional time points (3, 6 and 12 months) after conclusion of the treatment. ]
    Reys Auditory Verbal Learning Test (RAVLT)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-85
  • Diagnosed with major depressive disorder (MDD, according to DSM-IV)
  • Inpatients who have been offered and have accepted ECT
  • Are eligible to participate
  • Score ≥ 20 Points on Montgomery Åsberg Depression Rating Scale (MADRS)
  • Must be proficient in spoken and written Swedish
  • American Society of Anaesthesiologists physical status classification (ASA) 1-3

Exclusion Criteria:

  • Co-morbid conditions that could interfere with the treatment (e.g. primary psychosis)
  • Habitual difficulties to speak, hear, remember or reason
  • Treatment according to LPT (Lagen om psykiatrisk tvångsvård; Compulsory Psychiatric Care Act)
  • On-going or recent (6 months) drug abuse
  • Known allergy to the active substance
  • Pregnant or breastfeeding women
  • Known cardiovascular disease, including angina, acute/chronic congestive heart failure, moderly hypertension or tachyarrhythmia (because exacerbation by sympathomimetic properties of ketamine)
  • Pathological conditions in central nervous system with risk of increased intracranial pressure (increased ICP with ketamine)
  • Glaucoma (increased IOP with ketamine)
  • Porphyria or thyroid disorder (enhanced sympathomimetic properties by ketamine)
  • Ongoing severe infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659085


Contacts
Contact: Pouya Movahed, MD, PhD +4646178825 pouya.movahed_rad@med.lu.se

Locations
Sweden
Department of Psychiatry Recruiting
Lund, Sweden, 221 85
Contact: Pouya Movahed, MD, PhD    +4646178825    Pouya.movahed_rad@med.lu.se   
Sponsors and Collaborators
Pouya Movahed Rad
Investigators
Principal Investigator: Pouya Movahed Rad, MD, PhD Psychiatric Neuromodulation Unit, Dept of Clinical Sciences Lund, Faculty of Medicine Lund University, Sweden

Responsible Party: Pouya Movahed Rad, MD, PhD, Region Skane
ClinicalTrials.gov Identifier: NCT02659085     History of Changes
Other Study ID Numbers: 2011-001520-37
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Pouya Movahed Rad, Region Skane:
Depressive Disorder, Major
Antidepressive Agents/adverse effects
Depressive Disorder, Major/drug therapy
Infusions, Intravenous
Ketamine/administration & dosage*
Ketamine/adverse effects
Treatment Outcome
Electroconvulsive therapy

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action