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Botulinum Toxin for the Treatment of Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University Hospital, Basel, Switzerland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hannover Medical School
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00934687
First received: July 6, 2009
Last updated: November 8, 2010
Last verified: November 2010
History of Changes
  Purpose

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).


Condition Intervention Phase
Depression
 Drug: clostridium botulinum toxin type A neurotoxin complex
Other: 0.9% NaCl solution
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clostridium Botulinum Type A Neurotoxin Complex for Adjuvant Treatment of Depressive Disorders - a Randomized Controlled Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Response rate (reduction in Ham-D score by >30% compared to baseline) [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Remission rate (number of patients with HAM-D score < 8) [ Time Frame: six weeks ] [ Designated as safety issue: No ]
  • Time to response (20% reduction of HAM-D score compared to baseline) [ Time Frame: two, four, or six weeks ] [ Designated as safety issue: No ]
  • response by self rating (BDI) [ Time Frame: six weeks ] [ Designated as safety issue: No ]
  • need for additional treatment [ Time Frame: eight weeks, twelve weeks, or sixteen weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
Placebo Comparator: 0.9% NaCl solution
0.9% NaCl solution will be injected like the experimental compound
 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

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934687

Locations
Germany
Medical School Hannover, Psychiatry, Social Psychiatry and Psychotherapy
Hannover, Germany, 30625
Switzerland
Psychiatric Hospital of the University of Basel
Basel, BS, Switzerland, 4025
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Hannover Medical School
Investigators
Principal Investigator: Marc A Wollmer, MD Psychiatry Hospital of the University of Basel, Basel, Switzerland
Principal Investigator: Tillmann HC Krüger, MD Medical School HannoverPsychiatry, Social Psychiatry and Psychotherapy, Hannover, Germany
  More Information

No publications provided

Responsible Party: M. Axel Wollmer/MD, Psychiatric Hospital of the University of Basel, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00934687     History of Changes
Other Study ID Numbers: 2009DR2125, EKBB14/09
Study First Received: July 6, 2009
Last Updated: November 8, 2010
Health Authority: Switzerland: Swissmedic
Switzerland: Ethikkommission
Switzerland: Federal Office of Public Health
Switzerland: Laws and standards

Keywords provided by University Hospital, Basel, Switzerland:
depression
depressive
botulinum
botox

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Botulinum Toxins, Type A
Botulinum Toxins
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013