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Botulinum Toxin for the Treatment of Depression

NCT ID: NCT00934687

Last Updated: 2013-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Depression

Keywords

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depression depressive botulinum botox

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

clostridium botulinum toxin type A neurotoxin complex

Intervention Type 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.

0.9% sodium chloride NaCl solution

0.9% NaCl solution will be injected like the experimental compound

Group Type PLACEBO_COMPARATOR

0.9% NaCl solution

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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Vistabel Botox Cosmetic Botox NaCl 0.9% B. Braun

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc A Wollmer, MD

Role: PRINCIPAL_INVESTIGATOR

Asklepios Klinik Nord - Ochsenzoll, Hamburg/D

Tillmann HC Krüger, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Medical School Hannover, Psychiatry, Social Psychiatry and Psychotherapy

Hanover, , Germany

Site Status

Psychiatry Hospital of the University of Basel, Basel, Switzerland

Basel, Basel Town, Switzerland

Site Status

Countries

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Germany Switzerland

Other Identifiers

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EKBB14/09

Identifier Type: -

Identifier Source: secondary_id

2009DR2125

Identifier Type: -

Identifier Source: org_study_id