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The Treatment of Depression With Botulinum Type A Toxin

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ClinicalTrials.gov Identifier: NCT01392963
Recruitment Status : Completed
First Posted : July 13, 2011
Results First Posted : July 25, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Seton Healthcare Family

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.

Condition or disease Intervention/treatment Phase
Depression Drug: botulinum toxin type A neurotoxin complex Drug: Placebo Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Treatment of Depression With Botulinum Type A Toxin (Botox): A Randomized, Double Blind, Crossover Study
Study Start Date : July 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: 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).
Drug: botulinum toxin type A neurotoxin complex
29-40 U injection
Other Name: Botox, botulinum toxin type A (BTA)

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

Experimental: 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).
Drug: botulinum toxin type A neurotoxin complex
29-40 U injection
Other Name: Botox, botulinum toxin type A (BTA)

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




Primary Outcome Measures :
  1. Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6 [ Time Frame: baseline and 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



Secondary Outcome Measures :
  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) [ Time Frame: Baseline (Week 0), Week 6, and Week 18 ]

    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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392963


Locations
United States, Texas
Seton Mind Institute: Medical Park Tower
Austin, Texas, United States, 78705
Sponsors and Collaborators
Seton Healthcare Family
Investigators
Principal Investigator: Michelle Magid, MD Seton Healthcare Family

Publications of Results:
Responsible Party: Seton Healthcare Family
ClinicalTrials.gov Identifier: NCT01392963     History of Changes
Other Study ID Numbers: CR-11-021
First Posted: July 13, 2011    Key Record Dates
Results First Posted: July 25, 2018
Last Update Posted: July 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Seton Healthcare Family:
botox
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Botulinum Toxins
Botulinum Toxins, Type A
Behavioral Symptoms
Mood Disorders
Mental Disorders
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents