Trial Outcomes & Findings for Post-Traumatic Stress Disorder (PTSD) and Seroquel (NCT NCT01066156)

Results Overview

We will compare patients' symptomatology at baseline vs. at 8 week timepoint Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS) Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136 For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Seroquel This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Overall Study STARTED	34
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Seroquel This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Overall Study ineligible	2
Overall Study Lost to Follow-up	7
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Post-Traumatic Stress Disorder (PTSD) and Seroquel

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Seroquel n=34 Participants This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	51.3 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: It was predicted that patients will show a change in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS).

We will compare patients' symptomatology at baseline vs. at 8 week timepoint Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS) Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136 For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed

Outcome measures

Outcome measures
Measure	Seroquel n=24 Participants This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.	7.3 units on a scale Standard Deviation 18.5

Adverse Events

Seroquel

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

Igor Elman

Cambridge Health Alliance

Phone: (617) 665-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place