Botulinum Toxin for the Treatment of Depression

Depression Clinical Trial

Official title:

Clostridium Botulinum Type A Neurotoxin Complex for Adjuvant Treatment of Depressive Disorders - a Randomized Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934687
• Other study ID #: 2009DR2125
• Secondary ID: EKBB14/09
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2009
• Last updated: August 13, 2013
• Start date: August 2009
• Est. completion date: October 2010

Study information

• Verified date: August 2013
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicSwitzerland: EthikkommissionSwitzerland: Federal Office of Public HealthSwitzerland: Laws and standards
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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:
• 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.

Locations

Country	Name	City	State
Germany	Medical School Hannover, Psychiatry, Social Psychiatry and Psychotherapy	Hannover
Switzerland	Psychiatry Hospital of the University of Basel, Basel, Switzerland	Basel	Basel Town

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Hannover Medical School

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (reduction in Ham-D score by >30% compared to baseline)		six weeks	No
Secondary	Remission rate (number of patients with HAM-D score < 8)		six weeks	No
Secondary	Time to response (20% reduction of HAM-D score compared to baseline)		two, four, or six weeks	No
Secondary	response by self rating (BDI)		six weeks	No
Secondary	need for additional treatment		eight weeks, twelve weeks, or sixteen weeks	No