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The Treatment of Depression With Botulinum Type A Toxin

This study is currently recruiting participants.
Verified April 2013 by Seton Family of Hospitals
Sponsor:
Information provided by (Responsible Party):
Seton Family of Hospitals
ClinicalTrials.gov Identifier:
NCT01392963
First received: July 8, 2011
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Depression
 Drug: Clostridium botulinum toxin type A neurotoxin complex
Other: 0.9% NaCl solution
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Treatment of Depression With Botulinum Type A Toxin (Botox): A Randomized, Double Blind, Crossover Study

Resource links provided by NLM:

MedlinePlus related topics: Botox Depression
U.S. FDA Resources

Further study details as provided by Seton Family of Hospitals:

Primary Outcome Measures:
  • Binary Measure of Response to Treatment [ Time Frame: 7 times throughout study ] [ Designated as safety issue: Yes ]

    Binary measure of response to treatment (positive outcome is defined as a reduction in Ham-D score by >50% as compared to baseline). To be measured at 0, 3, 6, 12, 15, 18, 24 weeks. For both placebo and active group, change from baseline (0 weeks) in Ham-D scores as compared to Ham-D scores at 3,6, and 12 weeks.

    For both placebo and active group, change from baseline (at week 12, when cross-over occurs) in Ham-D scores as compared to Ham-D scores at 15,18,and 24 weeks.



Secondary Outcome Measures:
  • Proportion of patients who achieve a Ham-D score < 8 [ Time Frame: 7 times throughout the study ] [ Designated as safety issue: No ]
    Proportion of patients who achieve a Ham-D score < 8. To be measured at 0, 3, 6,12,15,18, 24 weeks. Response rate by self report on Beck Depression Inventory (BDI)and Patient Health Questionnaire (PHQ-9) to be measured at 0, 3, 6, 12, 15, 18, 24 weeks For just the group given Botox at week 0, change from baseline (0 weeks) in Ham-D scores as compared to Ham-D scores at 3,6,12,15,18, and 24 weeks. This is to determine if there is improvement in depression even when the Botox has "worn off" according to cosmetic guidelines (i.e. approximately 16 weeks since injection).


Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Botox
clostridium botulinum toxin type A neurotoxin complex: Experimental A total of 29-40 U of clostridium botulinum toxin type A neurotoxin complex (Allergan) will be injected in the glabella region according to standard protocols of cosmetic botulinum toxin applications.
 Drug: Clostridium botulinum toxin type A neurotoxin complex
Botulinum Toxin Type A: Neurotoxin Complex
Other Name: Clostridium Botulinum Toxin Type A: Neurotoxin Complex
Placebo Comparator: Placebo
0.9% NaCl solution will be injected like the experimental compound
 Other: 0.9% NaCl solution
0.9% NaCl Solution: Placebo Comparator
Other Name: 0.9% NaCl solution B. Braun

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392963

Contacts
Contact: Poppy E Poth 512.324.1000 ext 89612 botoxfordepression@gmail.com
Contact: Araceli Guzman 512.324.3380

Locations
United States, Texas
Seton Mind Institute: Medical Park Tower Recruiting
Austin, Texas, United States, 78705
Contact: Poppy E Poth     512-324-1000 ext 89612     botoxfordepression@gmail.com    
Sponsors and Collaborators
Seton Family of Hospitals
Investigators
Principal Investigator: Michelle Magid, MD Seton Family of Hospitals
  More Information

No publications provided

Responsible Party: Seton Family of Hospitals
ClinicalTrials.gov Identifier: NCT01392963     History of Changes
Other Study ID Numbers: CR-11-021
Study First Received: July 8, 2011
Last Updated: April 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Seton Family of Hospitals:
botox
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Botulinum Toxins, Type A
Botulinum Toxins
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013