Randomized Controlled Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
|Parkinson Disease Depression||Biological: OnabotulinumtoxinA Biological: Control||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial of OnabotulinumtoxinA for Depression in Parkinson Disease|
- Hamilton Rating Scale for Depression (HDRS) [ Time Frame: Baseline and two visits over three months (weeks 6 and 12) ]Improvement on a clinician-rated objective scale for depression as assessed over two weeks (6 weeks and 12 weeks after treatment)
- Clinical Global Impression - Improvement (CGI-I) [ Time Frame: Baseline and two visits over three months (weeks 6 and 12) ]Improvement on a measure of global change from screening to study discontinuation
- Clinical Global Impression - Severity (CGI-S) [ Time Frame: Baseline and two visits over three months (weeks 6 and 12) ]Improvement on measure of global illness severity from screening to study discontinuation
- Beck Depression Inventory II [ Time Frame: Baseline and two visits over three months (weeks 6 and 12) ]Improvement on a participant-rated subjective scale for depression as assessed over two visits
- Clinical Severity Score for Glabellar Frown Lines [ Time Frame: Baseline and two visits over three months (weeks 6 and 12) ]Assessment of change in participant frowning before and after onabotulinumtoxinA injections and relationship with depressive symptoms
|Actual Study Start Date:||February 27, 2017|
|Estimated Study Completion Date:||February 28, 2018|
|Estimated Primary Completion Date:||December 31, 2017 (Final data collection date for primary outcome measure)|
One injection of onabotulinumtoxinA (29 units for women and 40 units for men) will be injected into two facial muscles - the corrugator and procerus.
OnabotulinumtoxinA (29 units for women; 40 units for men) diluted with 0.9% sodium chloride (saline) solution to 40 units per milliliter (mL) (0.725 mL for women, 1 mL for men)
Placebo Comparator: Control
One injection of saline solution will be injected into two facial muscles - the corrugator and procerus.
0.9% sodium chloride solution (saline) solution injections (0.725mL for women, 1mL for men)
Other Name: Normal saline
Depression is a common, but treatable, comorbid condition often seen in persons with Idiopathic Parkinson Disease (iPD). Depression in Parkinson Disease may be hard to treat as patients with iPD may be sensitive to side effect of medication. As a result, other treatments which have better side effects profiles than antidepressants may be equivalent (or better) options.
OnabotulinumtoxinA is a purified formulation of botulinum toxin serotype A which is widely utilized for neurological (and cosmetic) purposes in medicine. OnabotulinumtoxinA has preliminary studies showing it may be beneficial for the treatment of Major Depressive Disorder when given in isolated injections to facial muscles (corrugator and procerus). When given in low doses, onabotulinumtoxinA is thought to have minimal side effects.
The investigators propose that a single treatment onabotulinumtoxinA may improve symptoms of depression in persons with Parkinson Disease over three months compared to placebo. The investigators plan to use both subjective and objective evaluations of depression symptoms and regular physical exams to ensure physical (motor) symptoms of Parkinson Disease do not worsen.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03069911
|Contact: Alexander Pantelyat, MD||410-614-1522|
|United States, Maryland|
|Johns Hopkins University School of Medicine||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Alexander Pantelyat, MD 410-502-3290 firstname.lastname@example.org|
|Contact: Ankur Butala, MD 410-502-0133 email@example.com|
|National Institutes of Health||Not yet recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: Mark Hallett, MD 301-496-9526 firstname.lastname@example.org|
|Contact: Imran Khan, MD 301-496-9526 email@example.com|
|Principal Investigator:||Alexander Pantelyat, MD||Johns Hopkins University|