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

NCT00585585 | Terminated Phase 2 Results DMC

• 1 other identifier: Nelson #1
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Major Depressive Disorder With Atypical Features

Keywords

Depression; Betahistine Dihydrochloride

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Arm 1: Betahistine dihydrochloride

EXPERIMENTAL

Oral betahistine dihydrochloride; daily dose 50-300 mg

Drug: betahistine dihydrochloride

Interventions

betahistine dihydrochloride DRUG

oral, 50-300 mg, daily

Also known as: SERC

Arm 1: Betahistine dihydrochloride

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have signed written informed consent
• Be male and/or female outpatients 18 65 years of age, inclusive
• 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 \[IUD\])
• Meet DSM IV1 criteria for major depressive episode (unipolar), with atypical features
• Have a score of 20 or greater on the Hamilton Depression Rating, 28-item version (HAM-D-28)
• Have a complete medical and psychiatric history, physical examination, laboratory evaluation, and ECG before study entry.
• Have baseline laboratory values and ECG that are normal, or abnormalities that are clinically insignificant

You may not qualify if:

• 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
• Have a history of peptic ulcer disease
• Have a history of severe asthma
• Have a current diagnosis of pheochromocytoma
• 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)
• Meet criteria for DSM IV1 psychoactive substance abuse or dependence in the past month
• Have a history of a psychotic disorder
• 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
• Have a history of hypersensitivity to betahistine dihydrochloride
• Exhibit, or suggestion that they may display, behavior that will not be conducive to the study procedures
• Are at significant risk of suicide as indicated by a score of 3 or greater on item number 11 on the HAM-D 28
• Have received any investigational product within 28 days of Screening
• Have used any antidepressant within 7 days of Screening (14 days for MAOIs; 21 days for fluoxetine)

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267-0559, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Betahistine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Erik Nelson, MD
• Organization: University of Cincinnati

erik.nelson@uc.edu

513-558-5115

Study Officials

• Erik Nelson, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 3, 2008
• Study Start: July 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 25, 2017
• Results First Posted: July 25, 2017

Record last verified: 2017-07

Locations

US (1)