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Completed

NCT Number: NCT00934687

Botulinum Toxin for the Treatment of Depression

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).

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical School Hannover, Psychiatry, Social Psychiatry and Psychotherapy, Hanover, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clostridium botulinum toxin type A neurotoxin complex

Drug

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

0.9% NaCl solution

Other

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

Primary outcomes

  1. Response rate (reduction in Ham-D score by >30% compared to baseline)

    Time frame: six weeks

Secondary outcomes

  1. Remission rate (number of patients with HAM-D score < 8)

    Time frame: six weeks

  2. Time to response (20% reduction of HAM-D score compared to baseline)

    Time frame: two, four, or six weeks

  3. response by self rating (BDI)

    Time frame: six weeks

  4. need for additional treatment

    Time frame: eight weeks, twelve weeks, or sixteen weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Hannover Medical School

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 8, 2009
Registry last updated
Aug 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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