Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000569101
Ethics application status
Approved
Date submitted
9/04/2019
Date registered
11/04/2019
Date last updated
17/08/2022
Date data sharing statement initially provided
11/04/2019
Date results information initially provided
17/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A dose-response study of scopolamine in major depressive disorder
Scientific title
A randomised, double-blind, active placebo-controlled, parallel groups dose-response study of intravenous scopolamine in major depressive disorder
Secondary ID [1] 297916 0
Nil
Universal Trial Number (UTN)
U1111-1221-5341
Trial acronym
DRESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder 312301 0
Condition category
Condition code
Mental Health 310862 310862 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 314136 0
Treatment: Drugs
Comparator / control treatment
A single intravenous infusion of 4 µg/kg glycopyrronium bromide given over 15 minutes under clinical observation
Control group
Active

Outcomes
Primary outcome [1] 319687 0
Total score of the Montomery-Asberg Depressive Rating Scale (MADRS)
Timepoint [1] 319687 0
24 hours post administration. Additional assessments are made at baseline, 2 days, 7 days, 14, days, 28 days and 42 days.
Secondary outcome [1] 369178 0
Total score of the Quantitative Inventory of Depressive Symptomology
Timepoint [1] 369178 0
24 hours post administration. Additional assessments are made at baseline, 2 days, 7 days, 14, days, 28 days and 42 days.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2019
Actual
12/08/2019
Date of last participant enrolment
Anticipated
1/05/2020
Actual
25/02/2021
Date of last data collection
Anticipated
15/06/2020
Actual
28/04/2021
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 21393 0
New Zealand
State/province [1] 21393 0

Funding & Sponsors
Funding source category [1] 302433 0
Government body
Name [1] 302433 0
Health Research Council of New Zealand
Country [1] 302433 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 302335 0
None
Name [1] 302335 0
Address [1] 302335 0
Country [1] 302335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303102 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 303102 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 303102 0
New Zealand
Date submitted for ethics approval [1] 303102 0
Approval date [1] 303102 0
08/04/2019
Ethics approval number [1] 303102 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92478 0
A/Prof Suresh Muthukumaraswamy
Address 92478 0
The University of Auckland
Building 505
85 Park Road
Grafton 1023
Auckland
Country 92478 0
New Zealand
Phone 92478 0
+64 9 3737599 ext 85398
Fax 92478 0
Email 92478 0
[email protected]
Contact person for public queries
Name 92479 0
Suresh Muthukumaraswamy
Address 92479 0
The University of Auckland
Building 505
85 Park Road
Grafton 1023
Auckland
Country 92479 0
New Zealand
Phone 92479 0
+64 9 3737599 ext 85398
Fax 92479 0
Email 92479 0
[email protected]
Contact person for scientific queries
Name 92480 0
Suresh Muthukumaraswamy
Address 92480 0
The University of Auckland
Building 505
85 Park Road
Grafton 1023
Auckland
Country 92480 0
New Zealand
Phone 92480 0
+64 9 3737599 ext 85398
Fax 92480 0
Email 92480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Chen JCC, Sumner RL, Naga VA, et al. A randomized ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised, double-blind, active placebo-controlled, parallel groups, dose-response study of scopolamine hydrobromide (4-6 mug/kg) in patients with major depressive disorder.2020https://dx.doi.org/10.1186/s13063-020-4089-6
EmbaseA Randomized Controlled Trial of Intravenous Scopolamine Versus Active-Placebo Glycopyrrolate in Patients With Major Depressive Disorder.2022https://dx.doi.org/10.4088/JCP.21m14310
N.B. These documents automatically identified may not have been verified by the study sponsor.