Back to resultsTrial of OnabotulinumtoxinA for Depression in Parkinson Disease
Primary Purpose
Parkinson Disease, Depression
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
OnabotulinumtoxinA
Control
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Parkinsonism, Depression, OnabotulinumtoxinA, BOTOX
Eligibility Criteria
Inclusion Criteria:
- Written informed consent is obtained in the English language;
- They are a 18 to 95 years old;
- They meet United Kingdom Brain Bank Criteria for probable idiopathic Parkinson disease;
- They meet Diagnostic and Statistical Manual (DSM)-IV criteria for major depressive disorder (MDD) as diagnosed by the M.I.N.I. at screening;
- They are judged by the investigator to have the capacity to understand the nature of the study;
- They are willing to comply with all the requirements of the study;
- They are considered by the investigator to be likely to adhere to the protocol.
Exclusion Criteria:
- They have been treated with onabotulinumtoxinA injected into the facial muscles for any reason in the 3 months prior to screening;
- They have Bipolar Disorder, Post-Traumatic Stress Disorder, a Psychotic Disorder or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening;
- They endorse active suicidal ideation at enrollment or during any study visit, or have attempted suicide in the six months prior to screening;
- They have a history of substance abuse or dependence in the 2 months prior to screening;
- They test positive for illicit drugs on urine screen, and this has not been adequately explained to the satisfaction of the investigator
- They are considered to be at significant risk of committing homicide;
- They have an unstable medical condition;
- Women of childbearing potential who are pregnant or are considering becoming pregnant during the length of the study;
- There has been a change in their PD medication or psychotherapy treatment regimen in the 30 days preceding screening;
- They are regarded, for any reason, by the principal investigator as being an unsuitable candidate for the protocol.
Sites / Locations
- Johns Hopkins University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
One injection of onabotulinumtoxinA (29 units for women and 40 units for men) will be injected into two facial muscles - the corrugator and procerus.
One injection of saline solution will be injected into two facial muscles - the corrugator and procerus.
Outcomes
Primary Outcome Measures
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)
Clinical Global Impression - Improvement (CGI-I)
Improvement on a measure of global change from screening to study discontinuation
Clinical Global Impression - Severity (CGI-S)
Improvement on measure of global illness severity from screening to study discontinuation
Beck Depression Inventory II
Improvement on a participant-rated subjective scale for depression as assessed over two visits
Secondary Outcome Measures
Clinical Severity Score for Glabellar Frown Lines
Assessment of change in participant frowning before and after onabotulinumtoxinA injections and relationship with depressive symptoms
Full Information
NCT ID
NCT03069911
First Posted
February 28, 2017
Last Updated
August 2, 2019
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03069911
Brief Title
Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
Official Title
Randomized Controlled Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit required participants
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Depression
Keywords
Parkinson Disease, Parkinsonism, Depression, OnabotulinumtoxinA, BOTOX
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
One injection of onabotulinumtoxinA (29 units for women and 40 units for men) will be injected into two facial muscles - the corrugator and procerus.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
One injection of saline solution will be injected into two facial muscles - the corrugator and procerus.
Intervention Type
Biological
Intervention Name(s)
OnabotulinumtoxinA
Other Intervention Name(s)
Botox, Botulinum Toxin Type A
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Control
Other Intervention Name(s)
Normal saline
Intervention Description
0.9% sodium chloride solution (saline) solution injections (0.725mL for women, 1mL for men)
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HDRS)
Description
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)
Title
Clinical Global Impression - Improvement (CGI-I)
Description
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)
Title
Clinical Global Impression - Severity (CGI-S)
Description
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)
Title
Beck Depression Inventory II
Description
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)
Secondary Outcome Measure Information:
Title
Clinical Severity Score for Glabellar Frown Lines
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent is obtained in the English language;
They are a 18 to 95 years old;
They meet United Kingdom Brain Bank Criteria for probable idiopathic Parkinson disease;
They meet Diagnostic and Statistical Manual (DSM)-IV criteria for major depressive disorder (MDD) as diagnosed by the M.I.N.I. at screening;
They are judged by the investigator to have the capacity to understand the nature of the study;
They are willing to comply with all the requirements of the study;
They are considered by the investigator to be likely to adhere to the protocol.
Exclusion Criteria:
They have been treated with onabotulinumtoxinA injected into the facial muscles for any reason in the 3 months prior to screening;
They have Bipolar Disorder, Post-Traumatic Stress Disorder, a Psychotic Disorder or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening;
They endorse active suicidal ideation at enrollment or during any study visit, or have attempted suicide in the six months prior to screening;
They have a history of substance abuse or dependence in the 2 months prior to screening;
They test positive for illicit drugs on urine screen, and this has not been adequately explained to the satisfaction of the investigator
They are considered to be at significant risk of committing homicide;
They have an unstable medical condition;
Women of childbearing potential who are pregnant or are considering becoming pregnant during the length of the study;
There has been a change in their PD medication or psychotherapy treatment regimen in the 30 days preceding screening;
They are regarded, for any reason, by the principal investigator as being an unsuitable candidate for the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Pantelyat, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Deidentified group data will be shared between the two study sites (Johns Hopkins and NIH)
Learn more about this trial
Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
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