The Treatment of Depression With Botulinum Type A Toxin

Depression Clinical Trial

Official title:

The Treatment of Depression With Botulinum Type A Toxin (Botox): A Randomized, Double Blind, Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392963
• Other study ID #: CR-11-021
• Status: Completed
• Phase: Phase 2
• Start date: July 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2018
• Source: Seton Healthcare Family
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• botulinum toxin type A neurotoxin complex
29-40 U injection
• Placebo
29-40 U 0.9% NaCl injection

Locations

Country	Name	City	State
United States	Seton Mind Institute: Medical Park Tower	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Seton Healthcare Family

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	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 6/18 score - baseline week 0 score); Outcome measure is the change in HDRS-21 score 6 weeks after injection with placebo (week 0) and Botox (week 12) - HDRS-21 done at week 6 and week 18.	Baseline (Week 0), Week 6, and Week 18