NCT00934687

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_2 depression

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_2 depression

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
24 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

1.2 years

First QC Date

July 6, 2009

Last Update Submit

August 13, 2013

Conditions

Depression

Keywords

depressiondepressivebotulinumbotox

Outcome Measures

Primary Outcomes (1)

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

    six weeks

Secondary Outcomes (4)

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

    six weeks

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

    two, four, or six weeks

  • response by self rating (BDI)

    six weeks

  • need for additional treatment

    eight weeks, twelve weeks, or sixteen weeks

Study Arms (2)

clostridium botulinum toxin type A neurotoxin complex

EXPERIMENTAL

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

0.9% sodium chloride NaCl solution

PLACEBO COMPARATOR

0.9% NaCl solution will be injected like the experimental compound

Other: 0.9% NaCl solution

Interventions

clostridium botulinum toxin type A neurotoxin complexDRUG

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.

Also known as: Vistabel, Botox Cosmetic, Botox
clostridium botulinum toxin type A neurotoxin complex
0.9% NaCl solutionOTHER

0.9% NaCl solution will be injected in analogy to clostridium botulinum toxin type A neurotoxin complex as a placebo comparator.

Also known as: NaCl 0.9% B. Braun
0.9% sodium chloride NaCl solution

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to moderate depression (Ham-D \>=15)
  • Therapy with one antidepressant for at least four weeks
  • at least moderate frown line

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical School Hannover, Psychiatry, Social Psychiatry and Psychotherapy

Hanover, 30625, Germany

Location

Psychiatry Hospital of the University of Basel, Basel, Switzerland

Basel, Basel Town, Switzerland

Location

MeSH Terms

Conditions

Depression

Interventions

Botulinum Toxins, Type ASaline Solution

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 8, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations

DE(1)CH(1)