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The Antidepressant Efficacy of the Anticholinergic Scopolamine

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT00369915
First received: August 29, 2006
Last updated: September 22, 2016
Last verified: September 2016
Results First Received: April 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Unipolar Depression
Bipolar Depression
Intervention: Drug: Scopolamine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Plac/Scop 6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
Scop/Plac 6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals

Participant Flow:   Overall Study
    Plac/Scop   Scop/Plac
STARTED   10   7 
COMPLETED   4   4 
NOT COMPLETED   6   3 
expected side effects                2                1 
Withdrawal by Subject                4                1 
W/drawl by investigators                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Plac/Scop 6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
Scop/Plac 6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
Total Total of all reporting groups

Baseline Measures
   Plac/Scop   Scop/Plac   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   7   17 
Age 
[Units: Years]
Mean (Standard Deviation)
 31  (6.6)   33  (10.4)   31.9  (8.2) 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   10   7   17 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   6   6   12 
Male   4   1   5 


  Outcome Measures
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1.  Primary:   Change in Depression Severity   [ Time Frame: Outcome measures obtained at each of 12 sessions ]

2.  Secondary:   Hamilton Anxiety Rating Scale   [ Time Frame: Each of 12 sessions. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Maura Furey, PhD
Organization: NIMH/NIH
phone: 301-594-7773
e-mail: mfurey@mail.nih.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT00369915     History of Changes
Other Study ID Numbers: 060234
06-M-0234
Study First Received: August 29, 2006
Results First Received: April 11, 2014
Last Updated: September 22, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration