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Pilot Study of Betahistine Dihydrochloride in the Treatment of Major Depression With Atypical Features

This study has been terminated.
(Lack of participants)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585585
First Posted: January 3, 2008
Last Update Posted: July 25, 2017
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.
Information provided by (Responsible Party):
Erik Nelson, University of Cincinnati
Results First Submitted: March 8, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Recurrent Major Depressive Disorder With Atypical Features
Intervention: Drug: betahistine dihydrochloride

  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
enrollment began 7/1/2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
7 patients signed consent & 6 patients screen-failed

Reporting Groups
  Description
Betahistine Dihydrochloride All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.

Participant Flow:   Overall Study
    Betahistine Dihydrochloride
STARTED   1 
Patients Receiving Drug   1 
COMPLETED   0 
NOT COMPLETED   1 
Adverse Event                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
Betahistine Dihydrochloride All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.

Baseline Measures
   Betahistine Dihydrochloride 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      1 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   1 


  Outcome Measures

1.  Primary:   Maximum Tolerable Dose of Betahistine Dihydrochloride in mg   [ Time Frame: 7 weeks ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Erik Nelson, MD
Organization: University of Cincinnati
phone: 513-558-5115
e-mail: erik.nelson@uc.edu



Responsible Party: Erik Nelson, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00585585     History of Changes
Other Study ID Numbers: Nelson #1
First Submitted: December 28, 2007
First Posted: January 3, 2008
Results First Submitted: March 8, 2011
Results First Posted: July 25, 2017
Last Update Posted: July 25, 2017