Recurrent Major Depressive Disorder With Atypical FeaturesPhase 2NCT00585585
Pilot Study of Betahistine Dihydrochloride in the Treatment of Major Depression With Atypical Features
A Phase 2 study testing betahistine dihydrochloride in people with Recurrent Major Depressive Disorder With Atypical Features, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recurrent Major Depressive Disorder With Atypical Features
- What is being tested?
- betahistine dihydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jan 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati
Cincinnati, Ohio, 45267-0559
About this study
Official title: 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.
Read the 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.
- Being tested
- betahistine dihydrochloride
- Keywords
- Depression, Betahistine Dihydrochloride
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
betahistine dihydrochlorideDrug
Also called SERC
oral, 50-300 mg, daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Betahistine dihydrochloride | Experimental | Oral betahistine dihydrochloride; daily dose 50-300 mg Receives: Drug: betahistine dihydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Major Depressive Disorder With Atypical FeaturesStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Nelson, University of Cincinnati
- Investigators
- Erik Nelson, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585585
- Sponsor's protocol ID
- Nelson #1
- Status last verified
- Jul 2017
- First submitted
- 28 Dec 2007
- Last updated
- 25 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Betahistine Dihydrochloride in the Treatment of Major Depression With Atypical Features
- ClinicalTrials.gov ID
- NCT00585585
- Acronym / sponsor ID
- Nelson #1
- Keywords
- Depression, Betahistine Dihydrochloride
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participants
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Jan 2008 (estimated)
- Results
- Posted 25 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Betahistine dihydrochloride | Experimental | Drug: betahistine dihydrochlorideOral betahistine dihydrochloride; daily dose 50-300 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| betahistine dihydrochlorideAlso: SERCoral, 50-300 mg, daily | Drug | Arm 1: Betahistine dihydrochloride |
Primary outcome
Maximum Tolerable Dose of Betahistine Dihydrochloride in mg
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Nelson, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing betahistine dihydrochloride in people with Recurrent Major Depressive Disorder With Atypical Features, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerable Dose of Betahistine Dihydrochloride in mg (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.