DepressionPhase 2NCT00934687
Botulinum Toxin for the Treatment of Depression
A Phase 2 study testing clostridium botulinum toxin type A neurotoxin complex and 0.9% NaCl solution in people with Depression, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- clostridium botulinum toxin type A neurotoxin complex and 0.9% NaCl solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2009to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate depression (Ham-D >=15)
- Therapy with one antidepressant for at least four weeks
- at least moderate frown line
Who cannot join
- Bipolar depression
- Psychiatric comorbidity
- Severe somatic comorbidity
- Pregnancy
- Peculiarities at the injection site
- Psychiatric medication other than one antidepressant
Show all 9Show fewer
- Specific psychotherapy
- Previous application of botulinum toxin
- Medication interfering with botulinum toxin
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Medical School Hannover, Psychiatry, Social Psychiatry and Psychotherapy
Hanover, 30625
Switzerland1 site
Psychiatry Hospital of the University of Basel, Basel, Switzerland
Basel, Basel Town
About this study
Official title: Clostridium Botulinum Type A Neurotoxin Complex for Adjuvant Treatment of Depressive Disorders - a Randomized Controlled Pilot Study
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
- Depression
- Being tested
- clostridium botulinum toxin type A neurotoxin complex, 0.9% NaCl solution
- Keywords
- depression, depressive, botulinum, botox
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clostridium botulinum toxin type A neurotoxin complexDrug
Also called Vistabel, Botox Cosmetic, Botox
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% NaCl solutionOther
Also called NaCl 0.9% B. Braun
0.9% NaCl solution will be injected in analogy to clostridium botulinum toxin type A neurotoxin complex as a placebo comparator.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: 0.9% NaCl solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (reduction in Ham-D score by >30% compared to baseline)
Measured: six weeks
Secondary outcomes (4)
Remission rate (number of patients with HAM-D score < 8)
Measured: six weeks
Time to response (20% reduction of HAM-D score compared to baseline)
Measured: two, four, or six weeks
response by self rating (BDI)
Measured: six weeks
need for additional treatment
Measured: eight weeks, twelve weeks, or sixteen weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School
- Responsible party
- Sponsor
- Investigators
- Marc A Wollmer, MD, Principal investigator, Asklepios Klinik Nord - Ochsenzoll, Hamburg/DTillmann HC Krüger, MD, Principal investigator, Medical School HannoverPsychiatry, Social Psychiatry and Psychotherapy, Hannover, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934687
- Sponsor's protocol ID
- 2009DR2125
- Other IDs
- EKBB14/09
- Status last verified
- Aug 2013
- First submitted
- 6 Jul 2009
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clostridium Botulinum Type A Neurotoxin Complex for Adjuvant Treatment of Depressive Disorders - a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT00934687
- Acronym / sponsor ID
- 2009DR2125
- Conditions
- Depression
- Keywords
- depression, depressive, botulinum, botox
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Hannover Medical School
- Study start
- Aug 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clostridium botulinum toxin type A neurotoxin complex | Experimental | Drug: clostridium botulinum toxin type A neurotoxin complexA 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 | Placebo comparator | Other: 0.9% NaCl solution0.9% NaCl solution will be injected like the experimental compound |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild to moderate depression (Ham-D >=15)
- Therapy with one antidepressant for at least four weeks
- at least moderate frown line
Key exclusion criteria (9 listed)
- Bipolar depression
- Psychiatric comorbidity
- Severe somatic comorbidity
- Pregnancy
- Peculiarities at the injection site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clostridium botulinum toxin type A neurotoxin complexAlso: Vistabel, Botox Cosmetic, BotoxA 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% NaCl solutionAlso: NaCl 0.9% B. Braun0.9% NaCl solution will be injected in analogy to clostridium botulinum toxin type A neurotoxin complex as a placebo comparator. | Other | 0.9% sodium chloride NaCl solution |
Primary outcome
Response rate (reduction in Ham-D score by >30% compared to baseline)
Time frame: six weeks
4 secondary outcomes
Remission rate (number of patients with HAM-D score < 8)
Time frame: six weeks
Time to response (20% reduction of HAM-D score compared to baseline)
Time frame: two, four, or six weeks
response by self rating (BDI)
Time frame: six weeks
need for additional treatment
Time frame: eight weeks, twelve weeks, or sixteen weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc A Wollmer, MD principal investigator
Asklepios Klinik Nord - Ochsenzoll, Hamburg/D
Tillmann HC Krüger, MD principal investigator
Medical School HannoverPsychiatry, Social Psychiatry and Psychotherapy, Hannover, Germany
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing clostridium botulinum toxin type A neurotoxin complex and 0.9% NaCl solution in people with Depression, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (reduction in Ham-D score by >30% compared to baseline) (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2013.