The Treatment of Depression With Botulinum Type A Toxin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seton Family of Hospitals
ClinicalTrials.gov Identifier:
NCT01392963
First received: July 8, 2011
Last updated: January 22, 2014
Last verified: January 2014

July 8, 2011
January 22, 2014
July 2011
November 2012   (final data collection date for primary outcome measure)
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.

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 >30% as compared to baseline). To be measured at 0, 3, 6, 12, 15, 18, 24 weeks
Complete list of historical versions of study NCT01392963 on ClinicalTrials.gov Archive Site
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).
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
Not Provided
Not Provided
 
The Treatment of Depression With Botulinum Type A Toxin
The Treatment of Depression With Botulinum Type A Toxin (Botox): A Randomized, Double Blind, Crossover Study

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Depression
  • Drug: Clostridium botulinum toxin type A neurotoxin complex
    Botulinum Toxin Type A: Neurotoxin Complex
    Other Name: Clostridium Botulinum Toxin Type A: Neurotoxin Complex
  • Other: 0.9% NaCl solution
    0.9% NaCl Solution: Placebo Comparator
    Other Name: 0.9% NaCl solution B. Braun
  • 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.
    Intervention: Drug: Clostridium botulinum toxin type A neurotoxin complex
  • Placebo Comparator: Placebo
    0.9% NaCl solution will be injected like the experimental compound
    Intervention: Other: 0.9% NaCl solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2013
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01392963
CR-11-021
Yes
Seton Family of Hospitals
Seton Family of Hospitals
Not Provided
Principal Investigator: Michelle Magid, MD Seton Family of Hospitals
Seton Family of Hospitals
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP