NCT01613820

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
3.2 years until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

May 31, 2012

Last Update Submit

February 15, 2018

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale - 28 items

    Subjects will be assessed with HAMD-28

    up to 4 months

Secondary Outcomes (1)

  • Systematic Assessment for Treatment Emergent Events (SAFTEE)

    up to 4 months

Study Arms (3)

Ketamine plus placebo

EXPERIMENTAL

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

Scopolamine plus placebo

EXPERIMENTAL

Subjects will receive a 15 minute infusion of IV scopolamine 2ug/kg followed by a 45 minute infusion of normal saline (placebo).

Drug: Scopolamine

Ketamine plus scopolamine

EXPERIMENTAL

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: KetamineDrug: Scopolamine

Interventions

KetamineDRUG

ketamine IV 0.25mg/kg infusions twice a week for 3 weeks as augmentation of ongoing antidepressant regimen.

Ketamine plus placeboKetamine plus scopolamine
ScopolamineDRUG

Scopolamine 2ug/kg over 15 minutes twice a week for 3 weeks as augmentation of ongoing antidepressant regimen

Ketamine plus scopolamineScopolamine plus placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Depression Clinical and Reseach Program - MGH

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

KetamineScopolamine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Cristina Cusin, M.D.

    MGH Department of Psychiatry

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor HMS

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 7, 2012

Study Start

September 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

US(1)