Trial of OnabotulinumtoxinA for Depression in Parkinson Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03069911
• Date of registration: 28/02/2017
• Prospective Registration: Yes
• Primary sponsor: Johns Hopkins University
• Public title: Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
• Scientific title: Randomized Controlled Trial of OnabotulinumtoxinA for Depression in Parkinson Disease
• Date of first enrolment: November 1, 2018
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03069911
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Alexander Pantelyat, MD
• Affiliation: Johns Hopkins University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 95 Years
Gender: All

Health Condition(s) or Problem(s) studied

Depression

Parkinson Disease

Intervention(s)

Biological: Control

Biological: OnabotulinumtoxinA

Primary Outcome(s)

Hamilton Rating Scale for Depression (HDRS) [Time Frame: Baseline and two visits over three months (weeks 6 and 12)]

Clinical Global Impression - Severity (CGI-S) [Time Frame: Baseline and two visits over three months (weeks 6 and 12)]

Beck Depression Inventory II [Time Frame: Baseline and two visits over three months (weeks 6 and 12)]

Clinical Global Impression - Improvement (CGI-I) [Time Frame: Baseline and two visits over three months (weeks 6 and 12)]

Secondary Outcome(s)

Clinical Severity Score for Glabellar Frown Lines [Time Frame: Baseline and two visits over three months (weeks 6 and 12)]

Secondary ID(s)

IRB00082708

Source(s) of Monetary Support

Please refer to primary and secondary sponsors