A Phase 1 interventional study of OnabotulinumtoxinA and Control in Parkinson Disease and Depression, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2019-08-06.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Treatment
This study evaluates the efficacy of onabotulinumtoxinA (BOTOX®) in the treatment of depression associated with Idiopathic Parkinson Disease in adults. As a Randomized Controlled Trial, half of the participants will receive onabotulinumtoxinA injections and half will receive a placebo saline solution.
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.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's enrollment of 3 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Exclusion Criteria:
One injection of onabotulinumtoxinA (29 units for women and 40 units for men) will be injected into two facial muscles - the corrugator and procerus.
Biological: OnabotulinumtoxinA
One injection of saline solution will be injected into two facial muscles - the corrugator and procerus.
Biological: Control
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)
Also known as: Botox, Botulinum Toxin Type A
0.9% sodium chloride solution (saline) solution injections (0.725mL for women, 1mL for men)
Also known as: Normal saline
Hamilton Rating Scale for Depression (HDRS)
Improvement on a clinician-rated objective scale for depression as assessed over two weeks (6 weeks and 12 weeks after treatment)
Time frame: Baseline and two visits over three months (weeks 6 and 12)
Clinical Global Impression - Improvement (CGI-I)
Improvement on a measure of global change from screening to study discontinuation
Time frame: Baseline and two visits over three months (weeks 6 and 12)
Clinical Global Impression - Severity (CGI-S)
Improvement on measure of global illness severity from screening to study discontinuation
Time frame: Baseline and two visits over three months (weeks 6 and 12)
Beck Depression Inventory II
Improvement on a participant-rated subjective scale for depression as assessed over two visits
Time frame: Baseline and two visits over three months (weeks 6 and 12)
Clinical Severity Score for Glabellar Frown Lines
Assessment of change in participant frowning before and after onabotulinumtoxinA injections and relationship with depressive symptoms
Time frame: Baseline and two visits over three months (weeks 6 and 12)
Plan to share: No — Deidentified group data will be shared between the two study sites (Johns Hopkins and NIH)
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A