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Trial record 33 of 1067 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

The Treatment of Depression With Botulinum Type A Toxin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE July 8, 2011
First Posted Date  ICMJE July 13, 2011
Results First Submitted Date  ICMJE October 3, 2017
Results First Posted Date  ICMJE July 25, 2018
Last Update Posted Date July 25, 2018
Study Start Date  ICMJE July 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2011)
Binary Measure of Response to Treatment [ Time Frame: 7 times throughout study ]
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
Change History Complete list of historical versions of study NCT01392963 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2011)
Proportion of patients who achieve a Ham-D score < 8 [ Time Frame: 7 times throughout the study ]
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Treatment of Depression With Botulinum Type A Toxin
Official Title  ICMJE The Treatment of Depression With Botulinum Type A Toxin (Botox): A Randomized, Double Blind, Crossover Study
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.
Detailed Description Participants will be assigned to receive either placebo or botulinum toxin injections in the forehead
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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).
    Interventions:
    • Drug: botulinum toxin type A neurotoxin complex
    • Drug: Placebo
  • 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).
    Interventions:
    • Drug: botulinum toxin type A neurotoxin complex
    • Drug: Placebo
Publications * 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. doi: 10.4088/JCP.13m08845.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2011)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01392963
Other Study ID Numbers  ICMJE CR-11-021
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seton Healthcare Family
Study Sponsor  ICMJE Seton Healthcare Family
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michelle Magid, MD Seton Healthcare Family
PRS Account Seton Healthcare Family
Verification Date June 2018

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