Clinical trial NCT01392963: The Treatment of Depression With Botulinum Type A Toxin
Official title: The Treatment of Depression With Botulinum Type A Toxin (Botox): A Randomized, Double Blind, Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: botox
depression
Lead sponsor: Seton Healthcare Family
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A 24-week Randomized, Double-blind study treating people who suffer from depression who also have moderate to severe frown lines in forehead region with Botox injections. Subjects participating will have their photos taken and complete a questionnaire regarding their depression. They will see a psychiatrist at every visit who will assess their depression.

Detailed description: Participants will be assigned to receive either placebo or botulinum toxin injections in the forehead

Eligibility criteria: Inclusion Criteria:

1. Male/Female between the ages of 18 and 65
2. Major Depression Disorder as defined by DSM IV criteria and diagnosed by a psychiatrist. DSM (Diagnostic and Statistical Manual) IV criteria for depression are: a depressed mood or anhedonia for at least a two week period. This mood must represent a change from the person's normal mood; social, occupational, educational or other important functioning must also be negatively impaired by the change in mood. Major depressive disorder cannot be diagnosed if a person has a history of bipolar disorder or if the depressed mood is better accounted for by substance abuse or a psychotic disorder. In addition, the patient must have 5 of the following symptoms:

   * Significant weight loss or weight gain.
   * Insomnia or hypersomnia
   * Psychomotor agitation or retardation
   * Feelings of worthlessness or excessive guilt
   * Poor Concentration
   * Fatigue or loss of energy
   * Suicidal thoughts
3. History of depression for at least 6 months
4. Initial score 14 or higher on initial Hamilton Depression rating scale.
5. Melancholic facial expressions amenable to treatment with Botox. Photos will be taken of potential participants and ranked independently by two investigators, on a scale of 1-10 based on how negative they look, 10 being the highest. Patients with an average score of 6 or above will be included in the study

Exclusion Criteria:

1. Active substance abuse
2. Bipolar Depression
3. Subjects who are pregnant, nursing or trying to become pregnant during study participation
4. Subjects who are currently on more than 3 psychiatric medications at the time of enrollment
5. Current medications used to treat depression must be stable for at least 60 days prior to enrollment
6. Previous Botox treatment
7. The Principle Investigator has determined that this study is not in the best interest of the subject and therefore the subject will not be enrolled.

Primary outcomes:
measure: Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6
timeFrame: baseline and week 6
Secondary outcomes:
measure: Change From Baseline (Week 0) in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) at Week 6 (Six Weeks Post Placebo Injection at Week 0) and Week 18 (Six Weeks Post Botox Injection at Week 12)
timeFrame: Baseline (Week 0), Week 6, and Week 18
Other outcomes:
Locations:
city: Austin
country: United States
facility: Seton Mind Institute: Medical Park Tower
state: Texas
Study officials:
affiliation: Seton Healthcare Family
name: Michelle Magid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magid M, Reichenberg JS, Poth PE, Robertson HT, LaViolette AK, Kruger TH, Wollmer MA. Treatment of major depressive disorder using botulinum toxin A: a 24-week randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014 Aug;75(8):837-44. doi: 10.4088/JCP.13m08845.
citation: Crowley JS, Silverstein ML, Reghunathan M, Gosman AA. Glabellar Botulinum Toxin Injection Improves Depression Scores: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2022 Jul 1;150(1):211e-220e. doi: 10.1097/PRS.0000000000009240. Epub 2022 May 20.