Ketamine and Scopolamine Infusions for Treatment-resistant Major Depressive Disorder

Not Applicable

Withdrawn

• Conditions: Major Depressive Disorder
• Interventions: Drug: Ketamine; Drug: Scopolamine

• Registration Number: NCT01613820
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study First Submitted: 2012-05-31
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-07
• Study Start: 2015-09
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine plus scopolamine	Ketamine	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.
Scopolamine plus placebo	Scopolamine	Subjects will receive a 15 minute infusion of IV scopolamine 2ug/kg followed by a 45 minute infusion of normal saline (placebo).
Ketamine plus placebo	Ketamine	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.
Ketamine plus scopolamine	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.

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale - 28 items	up to 4 months	Subjects will be assessed with HAMD-28

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Depression Clinical and Reseach Program - MGH; 🇺🇸 Boston, Massachusetts, United States