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

This study has been completed.
Sponsor:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00585585
First received: December 28, 2007
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to determine a dose of the investigational drug betahistine 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.


Condition Intervention Phase
Major Depression, Atypical Features
Drug: Betahistine dihydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Betahistine Dihydrochloride in the Treatment of Major Depression With Atypical Features

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: December 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Betahistine dihydrochloride
oral, 50 mg/day - 300 mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585585

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
University of Cincinnati
  More Information

No publications provided

Responsible Party: Erik B. Nelson, MD / Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00585585     History of Changes
Other Study ID Numbers: Nelson #1
Study First Received: December 28, 2007
Last Updated: January 27, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Betahistine
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014