Ketamine and Scopolamine Infusions for Treatment-resistant Major Depressive Disorder

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01613820

Enrollment

Registered

2012-06-07

Start date

2015-09-30

Completion date

2017-02-28

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

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.

Interventions

DRUGKetamine

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

DRUGScopolamine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Hamilton Depression Rating Scale - 28 items	up to 4 months	Subjects will be assessed with HAMD-28

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026