Trial Outcomes & Findings for Generalized Anxiety and Seroquel (NCT NCT01066143)
NCT ID: NCT01066143
Last Updated: 2017-05-17
Results Overview
Changes in anxiety symptomatolgy
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
12 week
Results posted on
2017-05-17
Participant Flow
8 subjects participated in screening but later were found to be ineligible for study participation
Participant milestones
| Measure |
Seroquel XR
Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Seroquel XR
Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
|
|---|---|
|
Overall Study
ineligible for the study
|
8
|
Baseline Characteristics
Generalized Anxiety and Seroquel
Baseline characteristics by cohort
| Measure |
Seroquel XR
Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0
n=5 Participants
|
|
Sex: Female, Male
Female
|
0
n=5 Participants
|
|
Sex: Female, Male
Male
|
0
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weekPopulation: 8 subjects signed the consent but were later found to be ineligible; the study didn't start
Changes in anxiety symptomatolgy
Outcome measures
| Measure |
Seroquel XR
Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
|
|---|---|
|
Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.
|
0
|
Adverse Events
Seroquel XR
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