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

NCT01178671 | Completed Phase 4 Results

• 1 other identifier: R34MH091336
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to examine the efficacy of the combination of mirtazapine and sertraline in the treatment of posttraumatic stress disorder (PTSD). Sertraline is FDA-approved for PTSD, but it is often not fully effective. The combination of mirtazapine and serotonin reuptake inhibitors like sertraline has appeared highly effective in a related disorder -- depression. In this study, sixty patients with chronic PTSD will be randomized to treatment with either sertraline + mirtazapine or sertraline + placebo for 12 weeks. Patients who show at least a minimal response after 12 weeks will continue for another 12 weeks on the same treatment.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; trauma; anxiety disorder; medication; sertraline; mirtazapine; pharmacotherapy

Outcome Measures

Primary Outcomes (2)

• PTSD Severity

  PTSD severity will be measured by the Clinician-Administered Posttraumatic Stress Disorder Scale, from 0 (least severe) to 136 (most severe).

  up to 24 weeks

• Time to Discontinuation of Study Treatment

  up to 24 weeks

Secondary Outcomes (8)

• Alternative Measure of PTSD Severity

  up to 24 weeks

• PTSD Self-rated Severity

  up to 24 weeks

• Depression Severity

  up to 24 weeks

• Response Status

  up to 24 weeks

• Remission Status

  up to 24 weeks

Study Arms (2)

Sertraline and Mirtazapine

EXPERIMENTAL

Flexible dose of both medications for up to 24 weeks

Drug: Mirtazapine; Drug: Sertraline

Sertraline and Sugar pill

ACTIVE COMPARATOR

Sertraline and Sugar pill for up to 24 weeks

Drug: Sertraline; Other: Sugar pill

Interventions

Mirtazapine DRUG

Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Also known as: Remeron

Sertraline and Mirtazapine

Sertraline DRUG

Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Also known as: Zoloft

Sertraline and Mirtazapine; Sertraline and Sugar pill

Sugar pill OTHER

Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks

Also known as: placebo

Sertraline and Sugar pill

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current primary diagnosis of chronic PTSD
• Fluent in English or Spanish

You may not qualify if:

• Past or current schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial personality disorder.
• Substance abuse of dependence diagnosis in past 3 months
• Suicidal ideation or behavior in past 6 months that poses a significant danger.
• Medical illness that could significant increase risk of sertraline and mirtazapine treatment or assessment of response
• History of traumatic brain injury of greater than mild severity
• History of seizure disorder (except febrile seizure in childhood)
• Currently taking medication which has been effective for patient's PTSD.
• Inability to tolerate or unwillingness to accept a drug-free period prior to beginning the study for certain psychiatric medications.
• History of inability to tolerate sertraline or mirtazapine or inadequate response to an adequate trial of combined treatment.
• Pregnancy, lactation; for women of childbearing potential, not using an effective birth control method.
• Current cognitive-behavioral therapy. Any psychotherapy initiated within 3 months of beginning this study.

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Anxiety Disorders Clinic, New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• Schneier FR, Campeas R, Carcamo J, Glass A, Lewis-Fernandez R, Neria Y, Sanchez-Lacay A, Vermes D, Wall MM. COMBINED MIRTAZAPINE AND SSRI TREATMENT OF PTSD: A PLACEBO-CONTROLLED TRIAL. Depress Anxiety. 2015 Aug;32(8):570-9. doi: 10.1002/da.22384. Epub 2015 Jun 26.

  PMID: 26115513 DERIVED

Related Links

• The trauma program of the anxiety disorders clinic of New York State Psychiatric Institute/Columbia University. Click here for more information about this study:

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries; Anxiety Disorders

Interventions

Mirtazapine; Sertraline; Sugars

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Carbohydrates

Limitations and Caveats

small sample due to low recruitment

Results Point of Contact

• Title: Franklin Schneier MD
• Organization: Research Foundation for Mental Hygiene

fschneier@nyspi.columbia.edu

6467748041

Study Officials

• Franklin Schneier, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 10, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 8, 2016
• Results First Posted: February 29, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)