A dose-response study of scopolamine in major depressive disorder

Conditions

None listed

Brief summary

Depression is one of the leading health burdens in New Zealand. Currently prescribed medicines are ineffective in approximately one third of patients and so new treatments are needed. Some clinical trials indicate that the anti-nausea drug scopolamine may have anti-depressant effects. However, a re cent trial has shown no effects of scopolamine on depression. Further the dose response profile of scopolamine and the time-course of antidepressant effects (if any) have not been thoroughly described. In this trial we will conduct a dose-response trial of scopolamine in major depressive disorder and characterise the time-course of associated antidepressant effects.

Chen JCC, Sumner RL, Thorstensen EB, Hannam JA, Hoeh N, Ayeni HA, Singh V, Wilson A, Campbell D, Sundram F, Muthukumaraswamy S.

2025-11-01

10.1002/hup.70022

A Randomized Controlled Trial of Intravenous Scopolamine Versus Active-Placebo Glycopyrrolate in Patients With Major Depressive Disorder

Joseph C. C. Chen, Rachael L. Sumner, Venkat Krishnamurthy Naga, Nicholas Hoeh, Hafis Adetokunbo Ayeni et al. (10 authors)

The Journal of Clinical Psychiatry2022-08-1212 citations

10.4088/jcp.21m14310

A randomised, double-blind, active placebo-controlled, parallel groups, dose-response study of scopolamine hydrobromide (4-6 μg/kg) in patients with major depressive disorder.

Chen JCC, Sumner RL, Krishnamurthy Naga V, Hoeh N, Ayeni HA, Singh V, Sundram F, Campbell D, Muthukumaraswamy S.

2020-02-101 citations

10.1186/s13063-020-4089-6

Interventions

Arm 1: A single intravenous infusion of 4 µg/kg scopolamine hydrobromide given over 15 minutes under clinical observation Arm 2: A single intravenous infusion of 5 µg/kg scopolamine hydrobromide given over 15 minutes under clinical observation Arm 3: A single intravenous infusion of 6 µg/kg scopolamine hydrobromide given over 15 minutes under clinical observation

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

No

Inclusion criteria

• Major depressive disorder for at least two weeks, as assessed by both Clinical Interview using and the Mini-International Neuropsychiatric Interview (MINI) • A pre-trial Montgomery-Asberg Depression Rating Scale score of greater than 20 • Male or female, aged 18 years or above and less than 60. • In the Investigators’ opinion, is able and willing to comply with all trial requirements. • Participant is willing and able to give informed consent for participation in the trial.

Exclusion criteria

• Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. • Regular use of any medication deemed to be contraindicating as judged by the attending study clinicians. See • Contraindication to the use of scopolamine or glycopyrrolate according to manufacturer guideline • Significant renal or hepatic impairment. • Participants with glaucoma • Cardiovascular conditions including abnormal heart rate and blood pressure checked at screening. • History of psychosis. • Any unstable medical or neurologic condition. • Planned major changes to psychotropic medication. • Imminent risk of suicide as determined by clinical interview. • Problematic substance dependence in previous 3 months • Inability to speak or read English. • Stage 3 or higher treatment-resistant depression as defined by the Thase and Rush Staging criteria • Patients who have been referred by their GP to a Community Mental Health Centre (CMHC) for management, or who are under the care of a CMHC. • Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial.

Outcome results