Trial Outcomes & Findings for A Placebo-Controlled Study of Mirtazapine for PTSD (NCT NCT00302107)

Results Overview

Structured Interview of Posttraumatic Stress Disorder (SIP) is a 17-item clinician-administered scale for PTSD based on Diagnostic Statistical Manual-IV criteria. The SIP has excellent test-retest reliability (0.89; p=.00001), and internal consistency (Conbach α of 0.80). The SIP showed significant correlations with the DTS (r=0.67, p=.0001) and the Impact of Event Scale (r=0.49 p=.0001). Relative to the SCID diagnosis of PTSD, sensitivity, specificity, positive predictive value, negative predictive value, and efficiency values were 100% for all indices using a score of 20 on the SIP. Items are scored on a scale from 0-4 which are summed to yield a total score ranging from 0 to 68 (higher score means more symptomatic or worse outcome). A symptom is counted as positive if it is at least a 2 (moderate).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

78 participants

Primary outcome timeframe

Primary outcome is measured at baseline and week 8 (primary endpoint) with primary outcome change scores calculated as week 8 minus baseline score.

Results posted on

2014-11-26

Participant Flow

Participants were recruited from the Tuscaloosa and Birmingham VA Medical Centers between April 2006 and November 2010.

Prior to randomization, participants signed informed consent, were assessed to have met eligibility criteria including free of psychotropic medications for the previous two weeks (4 weeks for fluoxetine) prior to randomization.

Participant milestones

Participant milestones
Measure	Mirtazapine Mirtazapine up to 45mg/qhs (three 15mg pills) as tolerated.	Placebo Placebo up to three pills qhs
Overall Study STARTED	39	39
Overall Study COMPLETED	31	30
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Mirtazapine Mirtazapine up to 45mg/qhs (three 15mg pills) as tolerated.	Placebo Placebo up to three pills qhs
Overall Study Lost to Follow-up	6	5
Overall Study Protocol Violation	1	0
Overall Study Relocation	0	1
Overall Study Withdrawal by Subject	0	3
Overall Study Adverse Event	1	0

Baseline Characteristics

A Placebo-Controlled Study of Mirtazapine for PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mirtazapine n=39 Participants Mirtazapine up to 45 mg/qhs as tolerated	Placebo n=39 Participants Placebo up to three tablets qhs	Total n=78 Participants Total of all reporting groups
Age, Continuous	37.7 years STANDARD_DEVIATION 10.3 • n=5 Participants	38.1 years STANDARD_DEVIATION 9.5 • n=7 Participants	37.9 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	39 participants n=7 Participants	78 participants n=5 Participants

PRIMARY outcome

Timeframe: Primary outcome is measured at baseline and week 8 (primary endpoint) with primary outcome change scores calculated as week 8 minus baseline score.

Population: Randomized, took at least one dose of study medication, and returned for at least one visit post-randomization

Structured Interview of Posttraumatic Stress Disorder (SIP) is a 17-item clinician-administered scale for PTSD based on Diagnostic Statistical Manual-IV criteria. The SIP has excellent test-retest reliability (0.89; p=.00001), and internal consistency (Conbach α of 0.80). The SIP showed significant correlations with the DTS (r=0.67, p=.0001) and the Impact of Event Scale (r=0.49 p=.0001). Relative to the SCID diagnosis of PTSD, sensitivity, specificity, positive predictive value, negative predictive value, and efficiency values were 100% for all indices using a score of 20 on the SIP. Items are scored on a scale from 0-4 which are summed to yield a total score ranging from 0 to 68 (higher score means more symptomatic or worse outcome). A symptom is counted as positive if it is at least a 2 (moderate).

Outcome measures

Outcome measures
Measure	Mirtazapine n=37 Participants Mirtazapine up to 45mg/qhs as tolerated	Placebo n=34 Participants Placebo up to 3 tablets qhs
Structured Interview of Posttraumatic Stress Disorder (SIP)	-7.61 units on a scale Standard Deviation 9.89	-5.83 units on a scale Standard Deviation 7.41

Adverse Events

Mirtazapine

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mirtazapine n=39 participants at risk Mirtazapine up to 45mg/qhs as tolerated	Placebo n=39 participants at risk Placebo up to 3 tablets qhs
General disorders Any Adverse Event	56.4% 22/39 • Number of events 22 • For the duration of the 8-week study. All adverse events were collected. Adverse events were based on participant self report. Type of adverse event is not specified in final report.	61.5% 24/39 • Number of events 24 • For the duration of the 8-week study. All adverse events were collected. Adverse events were based on participant self report. Type of adverse event is not specified in final report.

Additional Information

Lori Davis, MD

Tuscaloosa VA Medical Center

Phone: 205-554-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place