Trial · NCT01178671

Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial

NCT01178671, Phase 4, Completed, Research Foundation for Mental Hygiene, Inc.; results first posted 2016-02-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial. Trials, record NCT01178671. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01178671

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial
NCT number: NCT01178671
Status: Completed
Phases: Phase 4
Enrollment: 38 participants, actual
Lead sponsor: Research Foundation for Mental Hygiene, Inc.
Conditions: Posttraumatic Stress Disorder
Interventions: Mirtazapine, Sertraline, Sugar pill
First posted: 2010-08-10
Last updated: 2016-04-08
Results first posted: 2016-02-29
Limitations and caveats: small sample due to low recruitment

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	PTSD Severity	up to 24 weeks	PTSD severity will be measured by the Clinician-Administered Posttraumatic Stress Disorder Scale, from 0 (least severe) to 136 (most severe).
Primary	Time to Discontinuation of Study Treatment	up to 24 weeks
Secondary	Alternative Measure of PTSD Severity	up to 24 weeks	as measured by the Short Posttraumatic Stress Disorder Rating Interview, which rates severity of PTSD from 0 (least severe) to 32 (most severe)
Secondary	PTSD Self-rated Severity	up to 24 weeks	as measured by the PTSD Checklist which rates severity of PTSD from 17 (least severe) to 85 (most severe).
Secondary	Depression Severity	up to 24 weeks	as measured by the 17-item Hamilton Rating Scale for Depression, which rates severity of depression on a scale from 0 (least depression) to 50 (greatest depression).
Secondary	Response Status	up to 24 weeks	Responders defined by Clinician Administered Posttraumatic Stress Disorder Scale total score decreased by at least 30% compared with baseline and Clinical Global Impression improvement score of =1 or 2 at endpoint
Secondary	Remission Status	up to 24 weeks	Remitter as defined by Clinician Administered Posttraumatic Stress Disorders Scale total score \<20 at endpoint
Secondary	Adverse Effects	up to 24 weeks	as assessed by Side Effect Checklist
Secondary	Sleep Quality	up to 24 weeks	as measured by Pittsburgh Sleep Quality Index, which rates severity of impairment in sleep quality from 0 (least impaired) to 21 (most impaired).
Secondary	Sexual Functioning	up to 24 weeks	as measured by Arizona Sexual Experiences Scale, which rates impairment in sexual functioning from 5 (least impaired) to 30 (most impaired).

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	PTSD Severity	up to 24 weeks	intention to treat sample	units on a scale	MEAN
PRIMARY	Time to Discontinuation of Study Treatment	up to 24 weeks		days	MEAN
SECONDARY	Alternative Measure of PTSD Severity	up to 24 weeks	completers	units on a scale	MEAN
SECONDARY	PTSD Self-rated Severity	up to 24 weeks	completers	units on a scale	MEAN
SECONDARY	Depression Severity	up to 24 weeks	intent to treat	units on a scale	MEAN
SECONDARY	Response Status	up to 24 weeks	intent to treat	percentage of subjects	NUMBER
SECONDARY	Remission Status	up to 24 weeks	intent to treat	percentage of subjects	NUMBER
SECONDARY	Adverse Effects	up to 24 weeks	intent to treat	percentage of subject dropped due to AEs	NUMBER
SECONDARY	Sleep Quality	up to 24 weeks	intent to treat	units on a scale	MEAN
SECONDARY	Sexual Functioning	up to 24 weeks	intent to treat	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
PTSD Severity	Sertraline and Mirtazapine	23.8	Standard Deviation 17.4	units on a scale
PTSD Severity	Sertraline and Sugar Pill	34.6	Standard Deviation 17.7	units on a scale
Time to Discontinuation of Study Treatment	Sertraline and Mirtazapine	95.2	Standard Deviation 73.1	days
Time to Discontinuation of Study Treatment	Sertraline and Sugar Pill	90.0	Standard Deviation 14.8	days
Alternative Measure of PTSD Severity	Sertraline and Mirtazapine	3.4	Standard Deviation 2.9	units on a scale
Alternative Measure of PTSD Severity	Sertraline and Sugar Pill	6.7	Standard Deviation 5.0	units on a scale
PTSD Self-rated Severity	Sertraline and Mirtazapine	33.2	Standard Deviation 18.4	units on a scale
PTSD Self-rated Severity	Sertraline and Sugar Pill	39.2	Standard Deviation 18.2	units on a scale
Depression Severity	Sertraline and Mirtazapine	6.4	Standard Deviation 6.1	units on a scale
Depression Severity	Sertraline and Sugar Pill	11.6	Standard Deviation 6.4	units on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sertraline and Mirtazapine	18
Overall Study	STARTED	Sertraline and Sugar Pill	18
Overall Study	COMPLETED	Sertraline and Mirtazapine	6
Overall Study	COMPLETED	Sertraline and Sugar Pill	3
Overall Study	NOT COMPLETED	Sertraline and Mirtazapine	12
Overall Study	NOT COMPLETED	Sertraline and Sugar Pill	15

Source ClinicalTrials.gov

Adverse events58

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	headache	Nervous system disorders	Sertraline and Mirtazapine	4	18
other	headache	Nervous system disorders	Sertraline and Sugar Pill	3	18
other	heartburn	Gastrointestinal disorders	Sertraline and Mirtazapine	5	18
other	heartburn	Gastrointestinal disorders	Sertraline and Sugar Pill	3	18
other	nausea	Gastrointestinal disorders	Sertraline and Mirtazapine	2	18
other	nausea	Gastrointestinal disorders	Sertraline and Sugar Pill	8	18
other	emesis	Gastrointestinal disorders	Sertraline and Mirtazapine	2	18
other	emesis	Gastrointestinal disorders	Sertraline and Sugar Pill	3	18
other	decreased appetite	Gastrointestinal disorders	Sertraline and Mirtazapine	3	18
other	decreased appetite	Gastrointestinal disorders	Sertraline and Sugar Pill	5	18

1 to 10 of 58Source ClinicalTrials.gov

See all 58 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sertraline and Mirtazapine
Total, all-cause mortality	Sertraline and Sugar Pill
Total, other adverse events	Sertraline and Mirtazapine	18	18
Total, other adverse events	Sertraline and Sugar Pill	18	18
Total, serious adverse events	Sertraline and Mirtazapine	0	18
Total, serious adverse events	Sertraline and Sugar Pill	0	18

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26115513	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R34MH091336	Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial	SCHNEIER, FRANKLIN R.	NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC	NATIONAL INSTITUTE OF MENTAL HEALTH	2010 to 2012

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Sertraline and Mirtazapine vs Sertraline and Sugar Pill: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01178671

GET https://conductscience.org/api/trials/v1/NCT01178671/events?page=2

API reference For AI assistants