Ketamine and Scopolamine Infusions for Treatment-resistant Major Depressive Disorder

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01613820

Collaborator

(none)

Enrollment

Location

Arms

17.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Ketamine Drug: Scopolamine	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Combination of Anticholinergic and Glutamatergic Effects in Treatment-resistant Major Depressive Disorder. A Pilot Study

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Hamilton Depression Rating Scale - 28 items [up to 4 months]
Subjects will be assessed with HAMD-28

Secondary Outcome Measures

Systematic Assessment for Treatment Emergent Events (SAFTEE) [up to 4 months]
Subjects will be monitored for emergence of side effects weekly for the first 8 weeks, then every two weeks for 8 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Depression Clinical and Reseach Program - MGH	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator: Cristina Cusin, M.D., MGH Department of Psychiatry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cristina Cusin, MD, Instructor HMS, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01613820

Other Study ID Numbers:

2012-P-000624

First Posted:

Jun 7, 2012

Last Update Posted:

Feb 19, 2018

Last Verified:

Feb 1, 2018

Additional relevant MeSH terms:

Depressive Disorder

Depression

Depressive Disorder, Major

Scopolamine

Ketamine

Butylscopolammonium Bromide

Study Results

No Results Posted as of Feb 19, 2018