Pilot Study of Betahistine Dihydrochloride in the Treatment of Major Depression With Atypical Features
Condition: Recurrent Major Depressive Disorder With Atypical Features
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: betahistine dihydrochloride
Intervention description: oral, 50-300 mg, daily
Intervention MeSH terms: Betahistine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression; Betahistine Dihydrochloride

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.
    

Eligibility 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)