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Completed

NCT Number: NCT01392963

The Treatment of Depression With Botulinum Type A Toxin

A 24-week Randomized, Double-blind study treating people who suffer from depression who also have moderate to severe frown lines in forehead region with Botox injections. Subjects participating will have their photos taken and complete a questionnaire regarding their depression. They will see a psychiatrist at every visit who will assess their depression.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seton Mind Institute: Medical Park Tower

Austin, Texas, 78705, United States

About this study

Participants will be assigned to receive either placebo or botulinum toxin injections in the forehead

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male/Female between the ages of 18 and 65
  • Major Depression Disorder as defined by DSM IV criteria and diagnosed by a psychiatrist. DSM (Diagnostic and Statistical Manual) IV criteria for depression are: a depressed mood or anhedonia for at least a two week period. This mood must represent a change from the person's normal mood; social, occupational, educational or other important functioning must also be negatively impaired by the change in mood. Major depressive disorder cannot be diagnosed if a person has a history of bipolar disorder or if the depressed mood is better accounted for by substance abuse or a psychotic disorder. In addition, the patient must have 5 of the following symptoms:
  • Significant weight loss or weight gain.
  • Insomnia or hypersomnia
  • Psychomotor agitation or retardation
  • Feelings of worthlessness or excessive guilt
  • Poor Concentration
  • Fatigue or loss of energy
  • Suicidal thoughts
  • History of depression for at least 6 months
  • Initial score 14 or higher on initial Hamilton Depression rating scale.
  • Melancholic facial expressions amenable to treatment with Botox. Photos will be taken of potential participants and ranked independently by two investigators, on a scale of 1-10 based on how negative they look, 10 being the highest. Patients with an average score of 6 or above will be included in the study

Exclusion criteria

  • Active substance abuse
  • Bipolar Depression
  • Subjects who are pregnant, nursing or trying to become pregnant during study participation
  • Subjects who are currently on more than 3 psychiatric medications at the time of enrollment
  • Current medications used to treat depression must be stable for at least 60 days prior to enrollment
  • Previous Botox treatment
  • The Principle Investigator has determined that this study is not in the best interest of the subject and therefore the subject will not be enrolled.

Treatment and study plan

botulinum toxin type A neurotoxin complex

Drug

29-40 U injection

Other names: Botox, botulinum toxin type A (BTA)

Placebo

Drug

29-40 U 0.9% NaCl injection

Other names: botulinum toxin type A neurotoxin complex matched injection

Primary outcomes

  1. Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6

    Time frame: baseline and week 6

    HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6 post injection score - baseline week 0 score).

    PRIMARY OUTCOME MEASURE IS THE CHANGE IN HDRS-21 SCORE AFTER WEEK 6

Secondary outcomes

  1. Change From Baseline (Week 0) in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) at Week 6 (Six Weeks Post Placebo Injection at Week 0) and Week 18 (Six Weeks Post Botox Injection at Week 12)

    Time frame: Baseline (Week 0), Week 6, and Week 18

    HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6/18 score - baseline week 0 score)

    Outcome measure is the change in HDRS-21 score 6 weeks after injection with placebo (week 0) and Botox (week 12) - HDRS-21 done at week 6 and week 18.

Sponsors and collaborators

Lead sponsor

Seton Healthcare Family

Other

Registry information

Official study title

The Treatment of Depression With Botulinum Type A Toxin (Botox): A Randomized, Double Blind, Crossover Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 13, 2011
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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