Trial Outcomes & Findings for PharmacofMRI (Functional Magnetic Resonance Imaging) of Anxiolytic Medications (Alprazolam) (NCT NCT00703885)
NCT ID: NCT00703885
Last Updated: 2014-12-22
Results Overview
Analysis not completed.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
Same Day
Results posted on
2014-12-22
Participant Flow
All subjects receive both doses of active drug and placebo in randomized order.
All subjects receive both doses of active drug and placebo in randomized order.
Participant milestones
| Measure |
ALL SUBJECTS RECEIVE ALL 3 TREATMENTS
Alprazolam Low Dose Alprazolam High Dose Placebo
Sequence of administration not available for subjects
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PharmacofMRI (Functional Magnetic Resonance Imaging) of Anxiolytic Medications (Alprazolam)
Baseline characteristics by cohort
| Measure |
ALL SUBJECTS RECEIVE ALL 3 TREATMENTS
n=16 Participants
Alprazolam Low Dose Alprazolam High Dose Placebo
Please note that this is a cross-over design with all subjects receiving all three treatments
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Same DayAnalysis not completed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Post-Rx AdministrationAnalysis of data not completed.
Outcome measures
Outcome data not reported
Adverse Events
ALL SUBJECTS RECEIVE ALL 3 TREATMENTS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place