The Treatment of Depression With Botulinum Type A Toxin

NCT01392963 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CR-11-021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

botox; depression

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6

  HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6 post injection score - baseline week 0 score). PRIMARY OUTCOME MEASURE IS THE CHANGE IN HDRS-21 SCORE AFTER WEEK 6

  baseline and week 6

Secondary Outcomes (1)

• 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)

  Baseline (Week 0), Week 6, and Week 18

Study Arms (2)

Botox, Then Placebo

EXPERIMENTAL

At baseline visit (week 0) participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications. After a 3 month evaluation period, participants received a placebo injection (matching botulinum toxin) to glabella region at study visit 4 (week 12).

Drug: botulinum toxin type A neurotoxin complex; Drug: Placebo

Placebo, Then Botox

EXPERIMENTAL

At baseline visit (week 0) participants received a placebo injection (matching botulinum toxin) to glabella region. After a 3 month evaluation period, participants received an injection of clostridium botulinum toxin type A neurotoxin complex (Allergan; total injection of 29-40 U) in the glabella region according to standard protocols of cosmetic botulinum toxin applications at study visit 4 (week 12).

Drug: botulinum toxin type A neurotoxin complex; Drug: Placebo

Interventions

botulinum toxin type A neurotoxin complex DRUG

29-40 U injection

Also known as: Botox, botulinum toxin type A (BTA)

Botox, Then Placebo; Placebo, Then Botox

Placebo DRUG

29-40 U 0.9% NaCl injection

Also known as: botulinum toxin type A neurotoxin complex matched injection

Botox, Then Placebo; Placebo, Then Botox

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/Female between the ages of 18 and 65
• 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
• History of depression for at least 6 months
• Initial score 14 or higher on initial Hamilton Depression rating scale.
• 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

You may not qualify if:

• Active substance abuse
• Bipolar Depression
• Subjects who are pregnant, nursing or trying to become pregnant during study participation
• Subjects who are currently on more than 3 psychiatric medications at the time of enrollment
• Current medications used to treat depression must be stable for at least 60 days prior to enrollment
• Previous Botox treatment
• 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.

Sponsors & Collaborators

• Seton Healthcare Family: lead

Study Sites (1)

Seton Mind Institute: Medical Park Tower

Austin, Texas, 78705, United States

Location

Related Publications (2)

• 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.

  PMID: 24910934 RESULT

• 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.

  PMID: 35588104 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

93% of participants were female. This did not allow for statistical analysis based on gender. Although statistically significant, the sample size of this study was small.

Results Point of Contact

• Title: Katherine Sebastian
• Organization: Seton Family of Hospitals

krsebastian@seton.org

512-324-9999

Study Officials

• Michelle Magid, MD

  Seton Healthcare Family

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 13, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: June 1, 2013
• Last Updated: July 26, 2018
• Results First Posted: July 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)