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Botulinum Toxin for the Treatment of Depression

NCT00934687 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-08-14

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hannover Medical School

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Marc A Wollmer, MD · Asklepios Klinik Nord - Ochsenzoll, Hamburg/D

  • Tillmann HC Krüger, MD · Medical School HannoverPsychiatry, Social Psychiatry and Psychotherapy, Hannover, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00934687 on ClinicalTrials.gov