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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Recurrent Major Depressive Disorder With Atypical Features

Intervention / Treatment
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* Drug: betahistine dihydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Betahistine dihydrochloride<br>Oral betahistine dihydrochloride; daily dose 50-300 mg | Drug: betahistine dihydrochloride<br>* oral, 50-300 mg, daily<br>* Other names: SERC;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Betahistine Dihydrochloride