Recurrent Major Depressive Disorder With Atypical Features
Conditions
Keywords
Depression, Betahistine Dihydrochloride
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.
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.
Interventions
oral, 50-300 mg, daily
Sponsors
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerable Dose of Betahistine Dihydrochloride in mg | 7 weeks | The highest betahistine dose that is well tolerated when patients are titrated from 50 mg to a maximum 300 mg of daily divided doses. |
Countries
United States
Participant flow
Recruitment details
enrollment began 7/1/2007
Pre-assignment details
7 patients signed consent & 6 patients screen-failed
Participants by arm
| Arm | Count |
|---|---|
| Betahistine Dihydrochloride All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Betahistine Dihydrochloride |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 54 years STANDARD_DEVIATION 0 |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
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.
Time frame: 7 weeks
Population: The patient did not complete the study and not enough data were collected to be analyzed.