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Evaluation of Quality of Life and Self-steem After Botox® in Depressed and Non-depressed Patients

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: NCT01004042
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : February 29, 2012
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Doris Hexsel, Brazilan Center for Studies in Dermatology

Tracking Information
First Submitted Date  ICMJE October 28, 2009
First Posted Date  ICMJE October 29, 2009
Last Update Posted Date February 29, 2012
Study Start Date  ICMJE October 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
WHOQOL BREF [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
  • Rosenberg Self-Esteem Scale [ Time Frame: 8 weeks ]
  • Beck Depression Inventory [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Quality of Life and Self-steem After Botox® in Depressed and Non-depressed Patients
Official Title  ICMJE Evaluation of Quality of Life and Self-steem After Botulinum Toxin type-a (Botox®) Injections in Depressed and Non-depressed Patients
Brief Summary

The primary objective of this study is to determine the alterations in quality of life and self-steem after BOTOX® injections in the glabella in depressed and non-depressed patients.

The secondary objective of this study are:

  • to elaborate a description of the muscles involved in the Veraguth Fold
  • to evaluate depressive symptoms using Beck Depression Inventory before and after Botox® injections.
  • to elucidate that depression is not a contraindication for botulinum toxin injections.
Detailed Description

The study consists of two groups: one with diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0) and other without diagnosis of depression.

Subjects with depression will be part of group 1. They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.

Subjects with no diagnosis of depression will be part of group 2. Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.

Four visits will be scheduled. Visit 0 (baseline), Visit 1 (intervention), visit 2 (4 weeks), visit 3 (8 weeks) visit 4 (12 weeks).

The scales for the assessment of depressive symptoms, Beck Depression Inventory (BDI), will be applied at visits 1,2,3,4; WHOQOL BREF will be applied at baseline visit and 4.

Rosenberg Self-Esteem Scale will be applied in all visits. Photographs will be taken as well as the dermatological evaluation of the wrinkles and folds will be assessed using a 4-points validated Severity Wrinkles Scale, and psychiatric evaluation as well, in both groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Quality of Life
Intervention  ICMJE Drug: Botulinum Toxin Type A - BOTOX
Subjects included in the study will receive injections of 20 U (as minimal dose) to 40 U (as maximum dose) of BTX-A (BOTOX®/Allergan, USA) diluted in 0.9% saline, according to standard injections of 4U in 5 points of glabellar area as the treatment.
Study Arms  ICMJE
  • Active Comparator: Depressed subjects
    Diagnosis of depression (diagnostic criteria from DSM-IV-TR and MINI International Neuropsychiatric Interview - Brazilian version 5.0.)They must be using a therapeutic dose of antidepressant for at least 2 months before the intervention prescribed by a psychiatrist.
    Intervention: Drug: Botulinum Toxin Type A - BOTOX
  • Active Comparator: Non Depressed subjects
    Subjects with no diagnosis of depression
    Intervention: Drug: Botulinum Toxin Type A - BOTOX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2009)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female subjects,aged between 25 to 60 years;
  2. Subjects diagnosed as having major depression according to the criteria of DSM-IV, MINI International Neuropsychiatric Interview (MINI Brazilian version 5.0.0);
  3. Subjects who are being administered a therapeutic dose of an approved, prescribed antidepressant medication (pattern doses of the literature), and have been using mentioned medication at a stable therapeutic dose for at least three months prior to the randomization visit;
  4. Subjects with mild (1), moderate (2) or severe (3) glabellar frown lines while at rest according the Severity Wrinkles Scales;
  5. Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method;
  6. Subjects who had never received botulinum toxin A previously;
  7. Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form;
  8. Subjects who will be available throughout the duration of the study;
  9. Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol;
  10. Subjects with Critical appreciation preserved, attested by their assistant psychiatrist (for group1);
  11. Subjects who reside with other family members who assume co-responsibility in the study.

Exclusion Criteria:

  1. Subjects whose medical history and physical examination present clinical pathology, as myasthenia gravis, Eaton-Lambert Syndrome, neoplasm, muscular diseases, motor neuron diseases, systemic autoimmune or neurological diseases;
  2. Pregnant or women in breastfeeding, or women planning to become pregnant
  3. Subjects with suicide risk;
  4. Subjects addicted to alcohol or illegal drugs within the last 6 months;
  5. Subjects using amino glycoside and penicillamine antibiotics, quinine and Ca2+ channel blockers;
  6. Subjects using medications that, in the opinion of the investigator may cause depression, such as beta-blockers, oral corticosteroids and interferon;
  7. Subjects who, in the opinion of the investigator, may potentially require psychiatric hospitalization during the course of the study;
  8. Subjects with inflammation or active infection in the area to be injected;
  9. Subjects with a history of non-adherence to medical treatment, or who demonstrate unwillingness to adhere to the study protocol;
  10. The presence of any additional active DSM-IV Axis I diagnosis, or mental retardation;
  11. History of psychiatric hospitalization within the past three years.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004042
Other Study ID Numbers  ICMJE 09-CBED09-02
Version 2.0: 10/07/2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Doris Hexsel, Brazilan Center for Studies in Dermatology
Study Sponsor  ICMJE Brazilan Center for Studies in Dermatology
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: Doris M Hexsel, MD Brazilian Center For Studies in Dermatology
PRS Account Brazilan Center for Studies in Dermatology
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP