The Treatment of Depression With Botulinum Type A Toxin

NCT ID: NCT01392963

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-06-30

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

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Botox, Then Placebo

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).

Group Type: EXPERIMENTAL

botulinum toxin type A neurotoxin complex

Intervention Type: DRUG

29-40 U injection

Placebo

Intervention Type: DRUG

29-40 U 0.9% NaCl injection

Placebo, Then Botox

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).

Group Type: EXPERIMENTAL

botulinum toxin type A neurotoxin complex

Intervention Type: DRUG

29-40 U injection

Placebo

Intervention Type: DRUG

29-40 U 0.9% NaCl injection

Interventions

botulinum toxin type A neurotoxin complex

29-40 U injection

Intervention Type: DRUG

Placebo

29-40 U 0.9% NaCl injection

Intervention Type: DRUG

Other Intervention Names

Botox, botulinum toxin type A (BTA); botulinum toxin type A neurotoxin complex matched injection

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seton Healthcare Family

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Magid, MD

Role: PRINCIPAL_INVESTIGATOR

Seton Healthcare Family

Locations

Seton Mind Institute: Medical Park Tower

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24910934 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35588104 (View on PubMed)

Other Identifiers

CR-11-021

Identifier Type: -

Identifier Source: org_study_id