The Treatment of Depression With Botulinum Type A Toxin
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|ClinicalTrials.gov Identifier: NCT01392963|
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : January 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Clostridium botulinum toxin type A neurotoxin complex Other: 0.9% NaCl solution||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Treatment of Depression With Botulinum Type A Toxin (Botox): A Randomized, Double Blind, Crossover Study|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||June 2013|
Active Comparator: Botox
clostridium botulinum toxin type A neurotoxin complex: Experimental A total of 29-40 U of clostridium botulinum toxin type A neurotoxin complex (Allergan) will be injected in the glabella region according to standard protocols of cosmetic botulinum toxin applications.
Drug: Clostridium botulinum toxin type A neurotoxin complex
Botulinum Toxin Type A: Neurotoxin Complex
Other Name: Clostridium Botulinum Toxin Type A: Neurotoxin Complex
Placebo Comparator: Placebo
0.9% NaCl solution will be injected like the experimental compound
Other: 0.9% NaCl solution
0.9% NaCl Solution: Placebo Comparator
Other Name: 0.9% NaCl solution B. Braun
- Binary Measure of Response to Treatment [ Time Frame: 7 times throughout study ]
Binary measure of response to treatment (positive outcome is defined as a reduction in Ham-D score by >50% as compared to baseline). To be measured at 0, 3, 6, 12, 15, 18, 24 weeks. For both placebo and active group, change from baseline (0 weeks) in Ham-D scores as compared to Ham-D scores at 3,6, and 12 weeks.
For both placebo and active group, change from baseline (at week 12, when cross-over occurs) in Ham-D scores as compared to Ham-D scores at 15,18,and 24 weeks.
- Proportion of patients who achieve a Ham-D score < 8 [ Time Frame: 7 times throughout the study ]Proportion of patients who achieve a Ham-D score < 8. To be measured at 0, 3, 6,12,15,18, 24 weeks. Response rate by self report on Beck Depression Inventory (BDI)and Patient Health Questionnaire (PHQ-9) to be measured at 0, 3, 6, 12, 15, 18, 24 weeks For just the group given Botox at week 0, change from baseline (0 weeks) in Ham-D scores as compared to Ham-D scores at 3,6,12,15,18, and 24 weeks. This is to determine if there is improvement in depression even when the Botox has "worn off" according to cosmetic guidelines (i.e. approximately 16 weeks since injection).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392963
|United States, Texas|
|Seton Mind Institute: Medical Park Tower|
|Austin, Texas, United States, 78705|
|Principal Investigator:||Michelle Magid, MD||Seton Healthcare Family|