Efficacy Study of Botox for Depression

NCT01556971 | Unknown Phase 4

• 1 other identifier: Botox 5515
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depression

Outcome Measures

Primary Outcomes (3)

• MADRS

  Efficacy will be assessed using: the Montgomery-Asberg Depression Rating Scale (MADRS) screening, visit 2 and discontinuation

  Patients will be followed for up to 10 weeks

• Beck Depression Inventory

  Efficacy will be assessed using the patient-rated Beck Depression Inventory II (BDI) at screening, visit 2 and discontinuation.

  Patients will be followed for up to 10 weeks

• CGI-I

  Efficacy will be assessed using the Clinical Global Impression-Improvement (CGI-I) at visit 2 and discontinuation

  Patients will be followed for up to 10 weeks

Study Arms (2)

Botox

ACTIVE COMPARATOR

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

Saline Solution

PLACEBO COMPARATOR

A saline solution will be injected in to the procerus and corrugator supercilii frown muscles of randomly chosen study participants.

Drug: Saline Solution

Interventions

Botox DRUG

Appropriate patients will randomly receive 29 units of Botox or a saline solution injected in to the procerus and corrugator supercilii frown muscles.

Botox

Saline Solution DRUG

29 units of saline solution will be injected in to the procerus and corrugator supercilii frown muscles of randomly chosen study participants.

Saline Solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Clinical Research Associates, LLC: lead

Study Sites (2)

Chevy Chase Cosmetic Center

Chevy Chase, Maryland, 20815, United States

Location

Capital Clinical Research Associates, LLC

Rockville, Maryland, 20852, United States

Location

Related Publications (1)

• 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.

  PMID: 24345483 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Joshua Z Rosenthal, MD

  Capital Clinical Research Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 19, 2012
• Study Start: February 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 19, 2012

Record last verified: 2012-03

Locations

US (2)