Efficacy Study of Botox for Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Capital Clinical Research Associates, LLC.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Capital Clinical Research Associates, LLC
ClinicalTrials.gov Identifier:
NCT01556971
First received: March 15, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

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 Intervention Phase
Major Depression
Drug: Botox
Drug: Saline Solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Capital Clinical Research Associates, LLC:

Primary Outcome Measures:
  • MADRS [ Time Frame: Patients will be followed for up to 10 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Efficacy will be assessed using the Clinical Global Impression-Improvement (CGI-I) at visit 2 and discontinuation


Estimated Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556971

Locations
United States, Maryland
Chevy Chase Cosmetic Center
Chevy Chase, Maryland, United States, 20815
Capital Clinical Research Associates, LLC
Rockville, Maryland, United States, 20852
Sponsors and Collaborators
Capital Clinical Research Associates, LLC
Investigators
Principal Investigator: Joshua Z Rosenthal, MD Capital Clinical Research Association
  More Information

No publications provided by Capital Clinical Research Associates, LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Capital Clinical Research Associates, LLC
ClinicalTrials.gov Identifier: NCT01556971     History of Changes
Other Study ID Numbers: Botox 5515
Study First Received: March 15, 2012
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Botulinum Toxins, Type A
Pharmaceutical Solutions
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014