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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Franklin Schneier, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier:
NCT01178671
First received: July 29, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Posttraumatic Stress Disorder
Drug: Mirtazapine
Drug: Sertraline
Other: Sugar pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Mirtazapine and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment of Post-traumatic Stress Disorder (PTSD)

Resource links provided by NLM:


Further study details as provided by Research Foundation for Mental Hygiene, Inc.:

Primary Outcome Measures:
  • PTSD severity [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    PTSD severity will be measured by the Clinician-Administered PTSD Scale

  • time to discontinuation of study treatment [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PTSD severity [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    measured by the Short PTSD Rating Interview

  • PTSD severity [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    as self-rated on the PTSD Checklist

  • Depression severity [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    as measured by the 17-item Hamilton Rating Scale for Depression

  • response status [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    as defined by decrease on CAPS of at least 30% compared with baseline and Clinical Global Impression improvement score of =1 or 2

  • Adverse effects [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
    as assessed by Side Effect Checklist

  • Sleep Quality [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    as measured by Pittsburgh Sleep Quality Index

  • sexual functioning [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
    as measured by Arizona Sexual Experiences Scale

  • PTSD severity [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    as measured by the Clinician Administered PTSD Scale

  • PTSD severity [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    as measured by the Short PTSD Rating Interview

  • PTSD severity [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    as measured by the PTSD Checklist

  • Depression severity [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    as measured by the 17-item Hamilton Rating Scale for Depression

  • Response status [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    as defined by decrease on CAPS of at least 30% compared with baseline and Clinical Global Impression improvement score of =1 or 2

  • Remission status [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    defined by CAPS <20

  • Remission status [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    as defined by CAPS <20

  • Adverse effects [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
    as assessed by Side Effect Checklist

  • Sleep Quality [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    as measured by Pittsburgh Sleep Quality Index

  • Sexual functioning [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
    as measured by Arizona Sexual Experiences Scale


Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sertraline and Mirtazapine
Flexible dose of both medications for up to 24 weeks
Drug: Mirtazapine
Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
Other Name: Remeron
Drug: Sertraline
Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Other Name: Zoloft
Active Comparator: Sertraline and Sugar pill
Sertraline and Sugar pill for up to 24 weeks
Drug: Sertraline
Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
Other Name: Zoloft
Other: Sugar pill
Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
Other Name: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178671

Locations
United States, New York
Anxiety Disorders Clinic, New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Research Foundation for Mental Hygiene, Inc.
Investigators
Principal Investigator: Franklin Schneier, MD New York State Psychiatric Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Franklin Schneier, Research Psychiatrist, Research Foundation for Mental Hygiene, Inc.
ClinicalTrials.gov Identifier: NCT01178671     History of Changes
Other Study ID Numbers: R34MH091336, R34MH091336
Study First Received: July 29, 2010
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Research Foundation for Mental Hygiene, Inc.:
PTSD
trauma
anxiety disorder
medication
sertraline
mirtazapine
pharmacotherapy

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Mianserin
Mirtazapine
Serotonin Uptake Inhibitors
Sertraline
Adrenergic Agents
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Central Nervous System Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014