Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboPlaceboKetamineWithdrawn

Ketamine and Scopolamine Infusions for Treatment-resistant Major Depressive Disorder

This study plas 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.

Target Enrollment
Not specified
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

Background reports show ketamine infusions produce acute reductions in depression and suicidal ideation; scopolamine also shows significant antidepressant effects sustained over time.

Randomized, parallel-design study comparing three arms (ketamine+placebo; scopolamine+placebo; ketamine+scopolamine). Treatments given twice weekly for three weeks (six sessions); follow-up assessments every two weeks for three months.

Study Protocol

Preparation

sessions

Dosing

6 sessions
60 min each

Integration

sessions

Study Arms & Interventions

Ketamine + placebo

experimental

15-minute saline then IV ketamine 0.25 mg/kg over 45 minutes; twice weekly for 3 weeks.

Interventions

  • Ketamine0.25 mg/kg
    via IV• twice a week for 3 weeks• 6 doses total

    45 min ketamine infusion following 15 min placebo

Scopolamine + placebo

experimental

IV scopolamine 2 µg/kg over 15 minutes then 45-minute saline infusion; twice weekly for 3 weeks.

Interventions

  • Placebo2 µg/kg
    via IV• twice a week for 3 weeks• 6 doses total

    Scopolamine 2 µg/kg over 15 min (active); saline 45 min as placebo comparator; compound recorded as placeholder reference

Ketamine + scopolamine

experimental

IV scopolamine 2 µg/kg over 15 min followed by IV ketamine 0.25 mg/kg over 45 min; twice weekly for 3 weeks.

Interventions

  • Placebo2 µg/kg
    via IV• twice a week for 3 weeks• 6 doses total

    Scopolamine 2 µg/kg over 15 min (active); compound recorded as placeholder reference

  • Ketamine0.25 mg/kg
    via IV• twice a week for 3 weeks• 6 doses total

    Ketamine 0.25 mg/kg over 45 min

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • 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

  • 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 Details

Locations

Depression Clinical and Reseach Program - MGH — Boston, Massachusetts, United States

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