A Placebo-Controlled Study of Mirtazapine for PTSD

PTSD Clinical Trial

— Mirtazapine  

Official title:

A Placebo-Controlled Study of Mirtazapine for PTSD in OIF/OEF Veterans and Veterans From All Other Southwest Asia Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449189
• Other study ID #: 0065
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2007
• Last updated: August 30, 2012
• Start date: October 2006
• Est. completion date: September 2011

Study information

• Verified date: August 2012
• Source: Tuscaloosa Research & Education Advancement Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD

Intervention

Drug:
• Mirtazapine
Mirtazapine vs. placebo
• Placebo
Placebo vs. Mirtazapine

Locations

Country	Name	City	State
United States	Tuscaloosa VA Medical Center	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Tuscaloosa Research & Education Advancement Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kim W, Pae CU, Chae JH, Jun TY, Bahk WM. The effectiveness of mirtazapine in the treatment of post-traumatic stress disorder: a 24-week continuation therapy. Psychiatry Clin Neurosci. 2005 Dec;59(6):743-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAPS score improvement		8 weeks	No
Secondary	Side effect assessments		8 weeks	No