Efficacy Study of Botox for Depression
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ClinicalTrials.gov Identifier: NCT01556971 |
Recruitment Status : Unknown
Verified March 2012 by Capital Clinical Research Associates, LLC.
Recruitment status was: Active, not recruiting
First Posted : March 19, 2012
Last Update Posted : March 19, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | March 15, 2012 | |||
First Posted Date ICMJE | March 19, 2012 | |||
Last Update Posted Date | March 19, 2012 | |||
Study Start Date ICMJE | February 2011 | |||
Estimated Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy Study of Botox for Depression | |||
Official Title ICMJE | A Controlled Study of the Efficacy of Botulinum Toxin A (Botox) for the Treatment of Major Depressive Disorder (MDD) | |||
Brief Summary | The objective of this proposed study is to obtain data on the efficacy of Botox in reducing symptoms of MDD in male and female patients between the ages of 18 and 65 years old. The secondary object is to visually assess each patient's frown before and after the Botox injection to determine if there is a correlation between changes in the frown and changes in mood. The patients will be photographed at screening, visit 2 and 3. Their frown lines will be compared to determine if there is a visible improvement in the frown lines corresponding to an improvement in the efficacy rating scores. |
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Detailed Description | This will be a double-blind study. To maintain the blinding of the study, none of the investigators who are assessing depression scores will be aware of the injection status of the patients. In addition, to maintain patient blinding, the patients will not be educated as to possible expected outcomes on facial expressions. Unless specifically informed, patients are generally unaware of the facial movement that is inhibited by Botulinum Toxin A. An unblinded physician will act as pharmacist for the study preparing the active drug and the placebo for the injections. Duration of Treatment: The study will be divided into three phases: screening and enrollment, treatment and follow-up. Patients who meet all criteria will be randomized at the screening visit. The treatment phase will last six (6) weeks after the investigational product is administered during which the patients will return to for a visit at week 3. Subjects will return to the office for a discontinuation visit at week six. General Design and Methodology: At screening, patients will sign consent and be diagnosed by means of the M.I.N.I. They will be assessed by a clinician who will perform the MADRS and CGI-S which are standardized ratings. They will complete the patient-rated BDI. Subjects will provide a urine sample for drug screening. WOCBP will be given a pregnancy test. Patients who meet all criteria will be randomly assigned to receive either the investigational product or placebo. The study medication or placebo will be injected into the procerus and corrugator supercilii frown muscles of each patient by a physician or physician's assistant. Each patient face will be photographed at this an all visits. Three weeks ± 7 days following the injection, each patient will return to the office where a clinician will administer the MADRS and the CGI-I. The patient will complete the BDI and adverse events (AEs) and concomitant medications will be collected. Six weeks ± 7 days following the injection, patients will return to the office where the clinician will administer the MADRS and CGI-I, collect AEs and concomitant medications. The patients will complete the BDI. All patients, whether on the active drug or the placebo, will be given a voucher which they may use for a free Botox injection at week 8, if , in the judgment of the investigator, it will be beneficial to the patient. Diagnosis and Criteria for Inclusion: Patients will be included in this study if they meet all of the following criteria:
Criteria for Exclusion: Patients will be excluded from this study if they meet any of the following criteria:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Major Depression | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Finzi E, Rosenthal NE. Treatment of depression with onabotulinumtoxinA: a randomized, double-blind, placebo controlled trial. J Psychiatr Res. 2014 May;52:1-6. doi: 10.1016/j.jpsychires.2013.11.006. Epub 2013 Dec 1. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
60 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | June 2012 | |||
Estimated Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:• Written informed consent is obtained;
Exclusion Criteria:• They have been treated with botulinum toxin A in the 12 months prior to screening;
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01556971 | |||
Other Study ID Numbers ICMJE | Botox 5515 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Capital Clinical Research Associates, LLC | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Capital Clinical Research Associates, LLC | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Capital Clinical Research Associates, LLC | |||
Verification Date | March 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |