Botulinum Toxin for the Treatment of Depression
Primary Purpose
Depression
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
clostridium botulinum toxin type A neurotoxin complex
0.9% NaCl solution
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, depressive, botulinum, botox
Eligibility Criteria
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
Sites / Locations
- Medical School Hannover, Psychiatry, Social Psychiatry and Psychotherapy
- Psychiatry Hospital of the University of Basel, Basel, Switzerland
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
clostridium botulinum toxin type A neurotoxin complex
0.9% sodium chloride NaCl solution
Arm Description
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.
0.9% NaCl solution will be injected like the experimental compound
Outcomes
Primary Outcome Measures
Response rate (reduction in Ham-D score by >30% compared to baseline)
Secondary Outcome Measures
Remission rate (number of patients with HAM-D score < 8)
Time to response (20% reduction of HAM-D score compared to baseline)
response by self rating (BDI)
need for additional treatment
Full Information
NCT ID
NCT00934687
First Posted
July 6, 2009
Last Updated
August 13, 2013
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Hannover Medical School
1. Study Identification
Unique Protocol Identification Number
NCT00934687
Brief Title
Botulinum Toxin for the Treatment of Depression
Official Title
Clostridium Botulinum Type A Neurotoxin Complex for Adjuvant Treatment of Depressive Disorders - a Randomized Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Hannover Medical School
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, depressive, botulinum, botox
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clostridium botulinum toxin type A neurotoxin complex
Arm Type
Experimental
Arm Description
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.
Arm Title
0.9% sodium chloride NaCl solution
Arm Type
Placebo Comparator
Arm Description
0.9% NaCl solution will be injected like the experimental compound
Intervention Type
Drug
Intervention Name(s)
clostridium botulinum toxin type A neurotoxin complex
Other Intervention Name(s)
Vistabel, Botox Cosmetic, Botox
Intervention Description
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 Type
Other
Intervention Name(s)
0.9% NaCl solution
Other Intervention Name(s)
NaCl 0.9% B. Braun
Intervention Description
0.9% NaCl solution will be injected in analogy to clostridium botulinum toxin type A neurotoxin complex as a placebo comparator.
Primary Outcome Measure Information:
Title
Response rate (reduction in Ham-D score by >30% compared to baseline)
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Remission rate (number of patients with HAM-D score < 8)
Time Frame
six weeks
Title
Time to response (20% reduction of HAM-D score compared to baseline)
Time Frame
two, four, or six weeks
Title
response by self rating (BDI)
Time Frame
six weeks
Title
need for additional treatment
Time Frame
eight weeks, twelve weeks, or sixteen weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc A Wollmer, MD
Organizational Affiliation
Asklepios Klinik Nord - Ochsenzoll, Hamburg/D
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tillmann HC Krüger, MD
Organizational Affiliation
Medical School HannoverPsychiatry, Social Psychiatry and Psychotherapy, Hannover, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical School Hannover, Psychiatry, Social Psychiatry and Psychotherapy
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Psychiatry Hospital of the University of Basel, Basel, Switzerland
City
Basel
State/Province
Basel Town
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Botulinum Toxin for the Treatment of Depression
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