Efficacy Study of Botox for Depression

• Status: Unknown status
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capital Clinical Research Associates, LLC
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA; Pharmaceutical Solutions

Criteria

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.