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A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans
This study is currently recruiting participants.
Verified by Tuscaloosa Research & Education Advancement Corporation, June 2008
First Received: March 16, 2007   Last Updated: June 23, 2008   History of Changes
Sponsored by: Tuscaloosa Research & Education Advancement Corporation
Information provided by: Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00449189
  Purpose

The primary objective is to evaluate the efficacy and tolerability of mirtazapine (Remeron) in the treatment of PTSD. Primary Hypothesis to be tested:

Veterans with PTSD will have improvement in their symptomatology after 8 weeks of treatment with mirtazapine compared to those treated with placebo.

After completion of the placebo-controlled phase, patients who agree to continue in the study will be treated with open-label mirtazapine for an additional 8 weeks.


Condition Intervention Phase
PTSD
Drug: Mirtazapine
Drug: Placebo
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans

Resource links provided by NLM:


Further study details as provided by Tuscaloosa Research & Education Advancement Corporation:

Primary Outcome Measures:
  • CAPS score improvement [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effect assessments [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo: Placebo Comparator
Placebo vs. Mirtazapine
Drug: Placebo
Placebo vs. Mirtazapine
Mirtazapine: Active Comparator
Mirtazapine vs. Placebo
Drug: Mirtazapine
Mirtazapine vs. placebo

Detailed Description:

After meeting inclusion criteria, the patients enter an 8-week randomized, double-blind, placebo-controlled treatment trial of mirtazapine. After completion of the placebo-controlled phase, patients may continue study participation in an open-label mirtazapine for an additional 8 weeks.

The VA Pharmacy has an established working relationship with the investigators. The pharmacist maintains the randomization log and verifies the order for the placebo or mirtazapine (15mg) in look-a-like capsules. The investigators and patients are kept blind to the contents of the capsules until the end of the entire study. See procedure grid in attached Work Proposed Section attached. Based on symptomology and occurrence of side effects, the investigator increases the medication in 15 mg (one capsule) increments every week, as tolerated, until a maximum therapeutic benefit is achieved, not to exceed 45 mg/day (3 capsules). The dosing is at bedtime. Compliance is assessed by biweekly pill count. Patients are given supportive clinical management during the clinic visits. An investigator is available by telephone 24 hrs a day in case of emergency. Patients may be seen more often if needed. At the end of the placebo-controlled phase, if the patients agree to continue in the study (confirmed at every visit) and they have not experienced an intolerable side effect related to the study medication, the patient will stop the placebo-controlled medication and begin open label mirtazapine, starting with 15mg at bedtime and titrating as tolerated to a maximum of 60mg/day.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of PTSD, confirmed by MINI and CAPS
  • Age 19 or older
  • No substance abuse/dependence for the previous 4 weeks (except for nicotine and caffeine)
  • Free of psychotropic medication for 2 weeks (except 4 weeks for fluoxetine)
  • Clinically normal physical and laboratory examination (lab profile listed below). LFTs up to 2.5 times the normal limit will be allowed.
  • Women of childbearing potential must be using medically approved methods of birth control (such as a condom, birth control pill, Depo-Provera, or diaphragm with spermicides)
  • Signed informed consent
  • Male or female, any race or ethic origin

Exclusion Criteria:

  • Lifetime history of bipolar I, psychotic, or cognitive disorders
  • Actively suicidal, homicidal, or psychotic
  • History of sensitivity to mirtazapine
  • Unstable general medical conditions
  • Score ≥ 6 on Question #10 of MADRS regarding suicidal ideation
  • Women who are pregnant, planning to become pregnant or breastfeed during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449189

Contacts
Contact: Lori L Davis, MD (205) 554-3819 Lori.Davis@va.gov
Contact: Jason Newell, PhD (205) 554-2000 ext 3574 Jason.Newell@va.gov

Locations
United States, Alabama
Tuscaloosa VA Medical Center Recruiting
Tuscaloosa, Alabama, United States, 35404
Principal Investigator: Lori L Davis, MD            
Sponsors and Collaborators
Tuscaloosa Research & Education Advancement Corporation
Investigators
Principal Investigator: Lori L. Davis, MD Tuscaloosa VA Medical Center
  More Information

Publications:
Responsible Party: Tuscaloosa Research Education & Advancement Corporation ( Lori L. Davis, M.D.; Chief, Research Service )
Study ID Numbers: 0065
Study First Received: March 16, 2007
Last Updated: June 23, 2008
ClinicalTrials.gov Identifier: NCT00449189     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Tuscaloosa Research & Education Advancement Corporation:
PTSD
Operation Iraqi Freedom veterans
Mirtazapine

Study placed in the following topic categories:
Neurotransmitter Agents
Adrenergic Agents
Psychotropic Drugs
Stress
Adrenergic alpha-Antagonists
Mirtazapine
Stress Disorders, Traumatic
Antidepressive Agents, Tricyclic
Histamine
Anxiety Disorders
Histamine Antagonists
Mental Disorders
Stress Disorders, Post-Traumatic
Histamine H1 Antagonists
Histamine phosphate
Adrenergic Antagonists
Antidepressive Agents

Additional relevant MeSH terms:
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Histamine Agents
Adrenergic alpha-Antagonists
Mirtazapine
Stress Disorders, Traumatic
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Anxiety Disorders
Histamine Antagonists
Mental Disorders
Therapeutic Uses
Stress Disorders, Post-Traumatic
Histamine H1 Antagonists
Adrenergic Antagonists
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on July 02, 2009