The Treatment of Depression With Botulinum Type A Toxin

Study Overview
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Brief Summary
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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
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Participants will be assigned to receive either placebo or botulinum toxin injections in the forehead

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

Conditions
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Depression

Intervention / Treatment
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* Drug: botulinum toxin type A neurotoxin complex
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox, Then Placebo<br>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<br>* 29-40 U injection<br>* Other names: Botox, botulinum toxin type A (BTA);Drug: Placebo<br>* 29-40 U 0.9% NaCl injection<br>* Other names: botulinum toxin type A neurotoxin complex matched injection;|
| Experimental: Placebo, Then Botox<br>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<br>* 29-40 U injection<br>* Other names: Botox, botulinum toxin type A (BTA);Drug: Placebo<br>* 29-40 U 0.9% NaCl injection<br>* Other names: botulinum toxin type A neurotoxin complex matched injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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botox, depression