Ketamine and Scopolamine Infusions for Treatment-resistant Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01613820
• Other study ID #: 2012-P-000624
• Status: Withdrawn
• Phase: N/A
• First received: May 31, 2012
• Last updated: February 15, 2018
• Start date: September 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• Ketamine
ketamine IV 0.25mg/kg infusions twice a week for 3 weeks as augmentation of ongoing antidepressant regimen.
• Scopolamine
Scopolamine 2ug/kg over 15 minutes twice a week for 3 weeks as augmentation of ongoing antidepressant regimen

Locations

Country	Name	City	State
United States	Depression Clinical and Reseach Program - MGH	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale - 28 items	Subjects will be assessed with HAMD-28	up to 4 months
Secondary	Systematic Assessment for Treatment Emergent Events (SAFTEE)	Subjects will be monitored for emergence of side effects weekly for the first 8 weeks, then every two weeks for 8 weeks.	up to 4 months