Efficacy Study of Botox for Depression
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depression | Drug: Botox Drug: Saline Solution | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Controlled Study of the Efficacy of Botulinum Toxin A (Botox) for the Treatment of Major Depressive Disorder (MDD) |
Study Start Date : | February 2011 |
Estimated Primary Completion Date : | June 2012 |
Estimated Study Completion Date : | June 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Botox
The study will be divided randomly into two groups of equal number; one arm will receive a Botox injection; the other will receive saline solution injection
|
Drug: Botox
Appropriate patients will randomly receive 29 units of Botox or a saline solution injected in to the procerus and corrugator supercilii frown muscles. |
Placebo Comparator: Saline Solution
A saline solution will be injected in to the procerus and corrugator supercilii frown muscles of randomly chosen study participants.
|
Drug: Saline Solution
29 units of saline solution will be injected in to the procerus and corrugator supercilii frown muscles of randomly chosen study participants. |
- MADRS [ Time Frame: Patients will be followed for up to 10 weeks ]Efficacy will be assessed using: the Montgomery-Asberg Depression Rating Scale (MADRS) screening, visit 2 and discontinuation
- Beck Depression Inventory [ Time Frame: Patients will be followed for up to 10 weeks ]Efficacy will be assessed using the patient-rated Beck Depression Inventory II (BDI) at screening, visit 2 and discontinuation.
- CGI-I [ Time Frame: Patients will be followed for up to 10 weeks ]Efficacy will be assessed using the Clinical Global Impression-Improvement (CGI-I) at visit 2 and discontinuation
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:• Written informed consent is obtained;
- They are a 18 to 65 years old;
- They meet DSM-IV criteria for MDD as diagnosed by the MINI at screening, and, their current episode must be at least one month in length;
- They have a MADRS score of ≥ 26 at screening;
- They have ≥ 4 on the CGI-S at screening
- Women of childbearing potential (WOCBP) are on an acceptable form of birth control and are not pregnant or lactating;
- They are judged by the investigator to have the capacity to understand the nature of the study;
- They are willing to comply with all the requirements of the study.
- They are considered by the investigator to be likely to adhere to the protocol.
Exclusion Criteria:• They have been treated with botulinum toxin A in the 12 months prior to screening;
- They have another Axis I disorder as a principal diagnosis in the 6 months prior to screening;
- They have a history of substance abuse or dependency in the 2 months prior to screening (recreational use of illicit drugs may be permissible, at the discretion of the investigator);
- They test positive for illicit drugs on urine drug screen, and this has not been adequately explained to the satisfaction of the investigator;
- They endorse MADRS item 10 (suicidal ideas) at a level of 5 or more or have attempted suicide in the six months prior to screening;
- They are considered to be at a significant risk of committing homicide;
- They have an unstable medical condition;
- Women of childbearing potential (WOCBP) who are pregnant or are considering becoming pregnant during the length of the study;
- They are regarded, for any reason by the principal investigator as being an unsuitable candidate for the protocol.
- There has been a change in their medication or psychotherapy treatment regimen in the month preceding screening;
- They have proved to be refractory to three or more adequate antidepressant treatments with methods that have different mechanisms of action.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556971
United States, Maryland | |
Chevy Chase Cosmetic Center | |
Chevy Chase, Maryland, United States, 20815 | |
Capital Clinical Research Associates, LLC | |
Rockville, Maryland, United States, 20852 |
Principal Investigator: | Joshua Z Rosenthal, MD | Capital Clinical Research Association |
Responsible Party: | Capital Clinical Research Associates, LLC |
ClinicalTrials.gov Identifier: | NCT01556971 |
Other Study ID Numbers: |
Botox 5515 |
First Posted: | March 19, 2012 Key Record Dates |
Last Update Posted: | March 19, 2012 |
Last Verified: | March 2012 |
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |