Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Botulinum Toxin for the Treatment of Depression

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: NCT00934687
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : August 14, 2013
Sponsor:
Collaborator:
Hannover Medical School
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE July 6, 2009
First Posted Date  ICMJE July 8, 2009
Last Update Posted Date August 14, 2013
Study Start Date  ICMJE August 2009
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
Response rate (reduction in Ham-D score by >30% compared to baseline) [ Time Frame: six weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
  • Remission rate (number of patients with HAM-D score < 8) [ Time Frame: six weeks ]
  • Time to response (20% reduction of HAM-D score compared to baseline) [ Time Frame: two, four, or six weeks ]
  • response by self rating (BDI) [ Time Frame: six weeks ]
  • need for additional treatment [ Time Frame: eight weeks, twelve weeks, or sixteen weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botulinum Toxin for the Treatment of Depression
Official Title  ICMJE Clostridium Botulinum Type A Neurotoxin Complex for Adjuvant Treatment of Depressive Disorders - a Randomized Controlled Pilot Study
Brief Summary Depression is frequently accompanied by a specific sad facial expression. This expression is in part mediated by the same muscle activity that produces frown lines. Based on the assumption that there is a positive feedback between depressed mood and the correspondent facial muscle activity (facial feedback) the investigators will conduct a randomized controlled pilot study in which the investigators will apply a classical cosmetic treatment of frown lines with injections of botulinum toxin to depressed patients who did not sufficiently respond to antidepressant medication. The investigators hypothesize that this treatment will contribute to the amelioration of depressive symptoms in these patients. This hypothesis is supported by a previous open case series in which remission of depression was reported after such treatment (Finzi and Wasserman, 2006).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: clostridium botulinum toxin type A neurotoxin complex
    A total of 20-50 U of clostridium botulinum toxin type A neurotoxin complex (Allergan) will be injected at four to six sites in the glabella region according to standard protocols of cosmetic botulinum toxin applications.
    Other Names:
    • Vistabel
    • Botox Cosmetic
    • Botox
  • Other: 0.9% NaCl solution
    0.9% NaCl solution will be injected in analogy to clostridium botulinum toxin type A neurotoxin complex as a placebo comparator.
    Other Name: NaCl 0.9% B. Braun
Study Arms  ICMJE
  • Experimental: clostridium botulinum toxin type A neurotoxin complex
    A total of 20-50 U of clostridium botulinum toxin type A neurotoxin complex (Allergan) will be injected at four to six sites in the glabella region according to standard protocols of cosmetic botulinum toxin applications.
    Intervention: Drug: clostridium botulinum toxin type A neurotoxin complex
  • Placebo Comparator: 0.9% sodium chloride NaCl solution
    0.9% NaCl solution will be injected like the experimental compound
    Intervention: Other: 0.9% NaCl solution
Publications * Not Provided

*   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 7, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Mild to moderate depression (Ham-D >=15)
  • Therapy with one antidepressant for at least four weeks
  • at least moderate frown line

Exclusion Criteria:

  • Bipolar depression
  • Psychiatric comorbidity
  • Severe somatic comorbidity
  • Pregnancy
  • Peculiarities at the injection site
  • Psychiatric medication other than one antidepressant
  • Specific psychotherapy
  • Previous application of botulinum toxin
  • Medication interfering with botulinum toxin
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 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 Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00934687
Other Study ID Numbers  ICMJE 2009DR2125
EKBB14/09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Hannover Medical School
Investigators  ICMJE
Principal Investigator: Marc A Wollmer, MD Asklepios Klinik Nord - Ochsenzoll, Hamburg/D
Principal Investigator: Tillmann HC Krüger, MD Medical School HannoverPsychiatry, Social Psychiatry and Psychotherapy, Hannover, Germany
PRS Account University Hospital, Basel, Switzerland
Verification Date August 2013

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