Trial Outcomes & Findings for Pilot Study of Betahistine Dihydrochloride in the Treatment of Major Depression With Atypical Features (NCT NCT00585585)

Results Overview

The highest betahistine dose that is well tolerated when patients are titrated from 50 mg to a maximum 300 mg of daily divided doses.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

7 weeks

Results posted on

2017-07-25

enrollment began 7/1/2007

7 patients signed consent \& 6 patients screen-failed

Participant milestones
Measure	Betahistine Dihydrochloride All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
Overall Study STARTED	1
Overall Study Patients Receiving Drug	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Betahistine Dihydrochloride All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
Overall Study Adverse Event	1

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

Baseline characteristics by cohort
Measure	Betahistine Dihydrochloride n=1 Participants All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	54 years STANDARD_DEVIATION 0 • n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	1 participants n=99 Participants

Timeframe: 7 weeks

Population: The patient did not complete the study and not enough data were collected to be analyzed.

The highest betahistine dose that is well tolerated when patients are titrated from 50 mg to a maximum 300 mg of daily divided doses.

Outcome data not reported

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Betahistine Dihydrochloride n=1 participants at risk All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
Gastrointestinal disorders Mild to Moderate Gastrointestinal irritation	100.0% 1/1 • Number of events 1 • Entire Study

University of Cincinnati

Phone: 513-558-5115