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.

Study Overview

• Status: Terminated
• Conditions: Recurrent Major Depressive Disorder With Atypical Features
• Intervention / Treatment: Drug: betahistine dihydrochloride

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0559
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Betahistine dihydrochloride; Oral betahistine dihydrochloride; daily dose 50-300 mg	Drug: betahistine dihydrochloride; oral, 50-300 mg, daily; Other Names: SERC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Tolerable Dose of Betahistine Dihydrochloride in mg	The highest betahistine dose that is well tolerated when patients are titrated from 50 mg to a maximum 300 mg of daily divided doses.	7 weeks

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Erik Nelson, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: December 28, 2007
• First Submitted That Met QC Criteria: December 28, 2007
• First Posted (Estimate): January 3, 2008

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Betahistine Dihydrochloride
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Histamine Agents; Histamine Agonists; Betahistine
• Other Study ID Numbers: Nelson #1