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

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. Identifier: NCT00585585
Recruitment Status : Terminated (Lack of participants)
First Posted : January 3, 2008
Results First Posted : July 25, 2017
Last Update Posted : July 25, 2017
Information provided by (Responsible Party):
Erik Nelson, University of Cincinnati

December 28, 2007
January 3, 2008
March 8, 2011
July 25, 2017
July 25, 2017
July 2007
January 2011   (Final data collection date for primary outcome measure)
Maximum Tolerable Dose of Betahistine Dihydrochloride in mg [ Time Frame: 7 weeks ]
The highest betahistine dose that is well tolerated when patients are titrated from 50 mg to a maximum 300 mg of daily divided doses.
To establish the maximum tolerable dose of betahistine dihydrochloride (betahistine) within the range of 50 mg to 300 mg/day that appears to be effective for atypical depression. [ Time Frame: 7 weeks ]
Complete list of historical versions of study NCT00585585 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Pilot Study of Betahistine Dihydrochloride in the Treatment of Major Depression With Atypical Features
A Pilot Study of Betahistine Dihydrochloride in the Treatment of Major Depression With Atypical Features
The purpose of this study is to determine a dose of the investigational drug betahistine dihydrochloride that is both well tolerated and potentially effective in treating the symptoms of atypical depression. Atypical depression is characterized by the ability of the person's mood to improve temporarily in response to positive events, as well as features such as increased appetite, increased sleep and severe fatigue.
All patients will start taking 50 mg of betahistine dihydrochloride on treatment day 1 (after baseline visit). Starting on day 4, the daily dose will be increased by adding a 50 mg dose. If tolerated, the daily dose will be titrated to 200 mg. At the end of week 3, the dose will be titrated to 300 mg.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Recurrent Major Depressive Disorder With Atypical Features
Drug: betahistine dihydrochloride
oral, 50-300 mg, daily
Other Name: SERC
Experimental: Arm 1: Betahistine dihydrochloride
Oral betahistine dihydrochloride; daily dose 50-300 mg
Intervention: Drug: betahistine dihydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Have signed written informed consent
  2. Be male and/or female outpatients 18 65 years of age, inclusive
  3. For women: must be surgically sterile, 2 years postmenopausal, or, if they have childbearing potential, using a medically accepted method of birth control and agree to continue use of this method for at least 30 days after the last dose of study drug (i.e., barrier method with spermicide, steroidal contraceptive or intrauterine device [IUD])
  4. Meet DSM IV1 criteria for major depressive episode (unipolar), with atypical features
  5. Have a score of 20 or greater on the Hamilton Depression Rating, 28-item version (HAM-D-28)
  6. Have a complete medical and psychiatric history, physical examination, laboratory evaluation, and ECG before study entry.
  7. Have baseline laboratory values and ECG that are normal, or abnormalities that are clinically insignificant

Exclusion Criteria:

  1. Have significant and/or unstable gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease; organic brain disease; or cancer as determined by history, physical, ECG, and laboratory examination
  2. Have a history of peptic ulcer disease
  3. Have a history of severe asthma
  4. Have a current diagnosis of pheochromocytoma
  5. Are pregnant, intending to become pregnant, nursing, at risk for pregnancy, or not practicing medically acceptable birth control. (A blood pregnancy test will be performed at the screening visit)
  6. Meet criteria for DSM IV1 psychoactive substance abuse or dependence in the past month
  7. Have a history of a psychotic disorder
  8. Use any medications that, in the judgment of the investigator, might have psychotropic effects, or interact unfavorably with betahistine dihydrochloride including centrally acting antihistaminic agents
  9. Have a history of hypersensitivity to betahistine dihydrochloride
  10. Exhibit, or suggestion that they may display, behavior that will not be conducive to the study procedures
  11. Are at significant risk of suicide as indicated by a score of 3 or greater on item number 11 on the HAM-D 28
  12. Have received any investigational product within 28 days of Screening
  13. Have used any antidepressant within 7 days of Screening (14 days for MAOIs; 21 days for fluoxetine)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Nelson #1
Not Provided
Not Provided
Erik Nelson, University of Cincinnati
University of Cincinnati
Not Provided
Principal Investigator: Erik Nelson, MD University of Cincinnati
University of Cincinnati
July 2017

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