Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder

NCT00120250 | Completed Phase 4 Results DMC

• 1 other identifier: 2005-P-000645
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to obtain data investigating the safety and efficacy of eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in sleep will be associated with improvement in overall PTSD symptoms, and patients with PTSD-related sleep disturbances will have abnormal levels of stress hormones.

Conditions

Post-Traumatic Stress Disorders

Keywords

PTSD; Sleep disturbance; Eszopiclone; Double-blind; Crossover

Outcome Measures

Primary Outcomes (2)

• Short PTSD Rating Interview (SPRINT)

  The SPRINT is a 8-item, clinician-administered scale assessing core and related symptoms of PTSD. Symptoms are rates on 5 point scales from 0 (not at all) to 4 (very much) where a higher value indicates a worse outcome.

  8 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  The PSQI is a 24-item, patient-administered scale that assess changes in sleep symptomatology. The total PSQI score ranges from 0 to 21 where a higher value indicates a worse sleep symptomatology.

  8 weeks

Secondary Outcomes (3)

• Sleep Latency

  8 weeks

• Total Sleep Time

  8 weeks

• Clinician-Administered PTSD Scale (CAPS)

  Week 3

Study Arms (2)

Eszopiclone

EXPERIMENTAL

Subjects received 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.

Drug: Eszopiclone

Placebo

PLACEBO COMPARATOR

Subjects received placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.

Drug: Eszopiclone

Interventions

Eszopiclone DRUG

The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.

Also known as: Lunesta

Eszopiclone; Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female outpatients 18-64 years of age with a primary diagnosis of PTSD as defined by DSM-IV criteria with associated sleep disturbance

You may not qualify if:

• Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception.
• Concurrent use of other psychotropic medications, other than antidepressants at stable dose for at least 4 weeks prior to randomization
• Serious medical illness or instability
• Seizure disorders with the exception of a history of febrile seizures if they occurred during childhood
• Concurrent psychotherapy initiated within one month of randomization or ongoing psychotherapy of any duration directed specifically toward treatment of PTSD and/or sleep disturbance
• Diagnosis of schizophrenia, mental retardation, OCD, organic medical disorders or bipolar disorder, eating disorders in the past 6 months, alcohol or substance abuse in the past 3 months, or dependence within the past 6 months.
• Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Pollack MH, Hoge EA, Worthington JJ, Moshier SJ, Wechsler RS, Brandes M, Simon NM. Eszopiclone for the treatment of posttraumatic stress disorder and associated insomnia: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Jul;72(7):892-7. doi: 10.4088/JCP.09m05607gry. Epub 2011 Feb 22.

  PMID: 21367352 RESULT

Related Links

• Official Website for the Center for Anxiety and Traumatic Stress Disorders

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Parasomnias

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Results Point of Contact

• Title: Dr. Mark Pollack
• Organization: Massachusetts General Hospital

mark_pollack@rush.edu

312-942-5372

Study Officials

• Mark Pollack, M.D.

  Massachusetts General Hospital

  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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Grainger Professor and Chairman

Study Record Dates

• First Submitted: July 7, 2005
• First Posted: July 15, 2005
• Study Start: June 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 26, 2016
• Results First Posted: February 12, 2014

Record last verified: 2016-03

Locations

US (1)