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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00934687 |
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Date of registration:
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06/07/2009 |
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Primary sponsor: |
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Public title:
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Botulinum Toxin for the Treatment of Depression
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Scientific title:
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Clostridium Botulinum Type A Neurotoxin Complex for Adjuvant Treatment of Depressive Disorders - a Randomized Controlled Pilot Study |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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30 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00934687 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Switzerland
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Contacts
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Name:
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Tillmann HC Krüger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical School HannoverPsychiatry, Social Psychiatry and Psychotherapy, Hannover, Germany |
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Name:
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Marc A Wollmer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Psychiatry Hospital of the University of Basel, Basel, Switzerland |
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Key inclusion & exclusion 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
Age minimum:
25 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Depression
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Intervention(s)
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Drug: clostridium botulinum toxin type A neurotoxin complex
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Other: 0.9% NaCl solution
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Primary Outcome(s)
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Response rate (reduction in Ham-D score by >30% compared to baseline)
[Time Frame: six weeks]
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Secondary Outcome(s)
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need for additional treatment
[Time Frame: eight weeks, twelve weeks, or sixteen weeks]
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Remission rate (number of patients with HAM-D score < 8)
[Time Frame: six weeks]
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response by self rating (BDI)
[Time Frame: six weeks]
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Time to response (20% reduction of HAM-D score compared to baseline)
[Time Frame: two, four, or six weeks]
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Secondary ID(s)
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2009DR2125
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EKBB14/09
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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