Botulinum Toxin for the Treatment of Depression

August 13, 2013 updated by: University Hospital, Basel, Switzerland

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Medical School Hannover, Psychiatry, Social Psychiatry and Psychotherapy
  • Switzerland
    • Basel Town
      • Basel, Basel Town, Switzerland
        • Psychiatry Hospital of the University of Basel, Basel, Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Botox
  • Botox Cosmetic
  • Vistabel
Placebo Comparator: 0.9% sodium chloride 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 Names:
  • NaCl 0.9% B. Braun

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate (reduction in Ham-D score by >30% compared to baseline)
Time Frame: six weeks
six weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Remission rate (number of patients with HAM-D score < 8)
Time Frame: six weeks
six weeks
Time to response (20% reduction of HAM-D score compared to baseline)
Time Frame: two, four, or six weeks
two, four, or six weeks
response by self rating (BDI)
Time Frame: six weeks
six weeks
need for additional treatment
Time Frame: eight weeks, twelve weeks, or sixteen weeks
eight weeks, twelve weeks, or sixteen weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Hannover Medical School

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

July 6, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

August 14, 2013

Last Update Submitted That Met QC Criteria

August 13, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009DR2125
  • EKBB14/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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