Text Size

Ketamine and Scopolamine Infusions for Treatment-resistant Major Depressive Disorder

This study is not yet open for participant recruitment.
Verified January 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01613820
First received: May 31, 2012
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

Ketamine infusions resulted in an acute reduction in global depression scores and in severity of suicidal ideation. Scopolamine infusions produced also a significant improvement in depression that was sustained over time.

We therefore plan to investigate the feasibility and efficacy of open-label repeated intravenous administration of ketamine and scopolamine combined in this population of severely depressed, treatment-resistant patients. The results from this study could lead to the development of new strategies for the treatment of patients with TRD.


Condition Intervention
Major Depressive Disorder
 Drug: Ketamine
Drug: Scopolamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination of Anticholinergic and Glutamatergic Effects in Treatment-resistant Major Depressive Disorder. A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale - 28 items [ Time Frame: up to 4 months ] [ Designated as safety issue: No ]
    Subjects will be assessed with HAMD-28


Secondary Outcome Measures:
  • Systematic Assessment for Treatment Emergent Events (SAFTEE) [ Time Frame: up to 4 months ] [ Designated as safety issue: Yes ]
    Subjects will be monitored for emergence of side effects weekly for the first 8 weeks, then every two weeks for 8 weeks.


Estimated Enrollment: 15
Study Start Date: May 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine plus placebo
Subjects assigned to this paradigm will receive a 15 minute infusion of normal saline (placebo) followed by IV ketamine at 0.25mg/kg over 45 minutes twice a week for 3 weeks.
 Drug: Ketamine
ketamine IV 0.25mg/kg infusions twice a week for 3 weeks as augmentation of ongoing antidepressant regimen.
Experimental: Scopolamine plus placebo
Subjects will receive a 15 minute infusion of IV scopolamine 2ug/kg followed by a 45 minute infusion of normal saline (placebo).
 Drug: Scopolamine
Scopolamine 2ug/kg over 15 minutes twice a week for 3 weeks as augmentation of ongoing antidepressant regimen
Experimental: Ketamine plus scopolamine
Subject will receive an IV scopolamine infusion at a dose of 2ug/kg over 15 minutes, followed by an IV infusion of ketamine at a dose of 0.25mg/kg over 45 minutes.
 Drug: Ketamine
ketamine IV 0.25mg/kg infusions twice a week for 3 weeks as augmentation of ongoing antidepressant regimen.
Drug: Scopolamine
Scopolamine 2ug/kg over 15 minutes twice a week for 3 weeks as augmentation of ongoing antidepressant regimen

Detailed Description:

Patients will undergo two weeks of prospective observation, they will then receive IV infusions of ketamine, scopolamine or both per randomization as augmentation of their ongoing antidepressant regime. The schedule of administration will be twice a week of three weeks. After this phase the subject will be followed with assessments every two weeks for three months.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients with sever treatment-resistant depression
  • Currently depressed
  • Currently under regular psychiatric care
  • On an aggressive antidepressant regimen, stable for 4 weeks

Exclusion Criteria:

  • No history of other major psychiatric illnesses, including bipolar disorder
  • No history of psychosis
  • No history of drug abuse
  • No major medical illness or unstable medical condition.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613820

Contacts
Contact: Kelley Durham 1-877-552-5838

Locations
United States, Massachusetts
Depression Clinical and Reseach Program - MGH Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Kelley Durham     887-552-5837     kedurham@partners.org    
Principal Investigator: Cristina Cusin, M.D.            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Cristina Cusin, M.D. MGH Department of Psychiatry
  More Information

No publications provided

Responsible Party: Cristina Cusin, MD, Instructor HMS, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01613820     History of Changes
Other Study ID Numbers: 2012-P-000624
Study First Received: May 31, 2012
Last Updated: January 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Scopolamine
Butylscopolammonium Bromide
Ketamine
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Parasympatholytics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on May 19, 2013