Overview

A Study of Eszopiclone in Subjects With Insomnia Related to Major Depressive Disorder

Status:
Completed
Trial end date:
2004-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate subjective sleep efficacy in subjects with insomnia related to major depressive disorder.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sunovion
Treatments:
Eszopiclone
Criteria
Inclusion Criteria:

- Subject must understand the purpose of the study and be willing to adhere to the study
schedule and procedures described in this protocol.

- Subject must be 21 to 64 years of age (inclusive) on the day of signing consent.

- Subject must meet criteria for a primary and principal diagnosis of Major Depressive
Disorder.

- Subject's current depressive episode is at least 2 weeks but not longer than 6 months
in duration.

- Subject must meet criteria for insomnia related to MDD and the symptoms of insomnia
must not pre-date the symptoms of MDD by more than 10 weeks.

- Subject must report a sleep onset time of > 30 minutes, and wake time after sleep
onset of > 45 minutes, and < 6.5 hours of total sleep time at least three times a week
over the previous month.

- Subject must take the Hamilton-D-17 scale and have a protocol pre-specified minimum
score.

- Subject must have no known clinically significant abnormal laboratory, ECG, or
physical examination findings at screening.

- Subject must meet one of the following conditions:

- Subject is not taking antidepressant medications at the time of study start.

- Subject is taking a sub-therapeutic dose of antidepressant or other disallowed
psychotropic medication and with the approval of the investigator agrees to taper off
of this medication, prior to completion of screening assessments at study start.

Exclusion Criteria:

- Female subject is pregnant, lactating or within 6 months post partum.

- Subject has known sensitivity to any selective SSRI, zopiclone, or eszopiclone.

- Subject has history of major depressive disorder that was refractory to treatment with
SSRIs.

- Subject has a current primary psychiatric diagnosis of any of the following disorders:
dementia, delirium, schizophrenia, psychosis, other psychotic disorders, dysthymic
disorder; bipolar disorders; cyclothymic disorder, other mood disorders, nocturnal
panic disorder, primary anxiety disorders, primary panic disorders or any other
psychiatric disorder that would compromise the investigator's ability to evaluate the
safety and efficacy of the study medication.

- Note: Subjects with Sexual and Gender Identity Disorders or other non-psychotic
disorders will be considered on a case-by-case basis. Subjects with MDD and a
secondary diagnosis of generalized anxiety disorder, panic disorders other than
nocturnal panic disorder or seasonal affective disorder will be allowed.

- Subject has any of the following Personality Disorders diagnoses: schizotypal,
schizoid, borderline personality disorder; mental retardation or any other personality
disorder that would compromise the investigator's ability to evaluate the safety and
efficacy of the study medication.

- Subject has difficulties in sleep initiation or maintenance associated with known
medical diagnosis [e.g. sleep apnea, restless leg syndrome (RLS), or periodic leg
movement syndrome (PLMS)], or has any condition that has or may affect sleep [(e.g.,
chronic pain, benign prostatic hypertrophy (BPH)].

- Subject has any clinically significant unstable medical or neurologic abnormality,
unstable chronic disease, or a history of a clinically significant abnormality of the
cardiovascular, respiratory, hepatic, or renal systems.

- Subject has a disorder or history of a condition (e.g., malabsorption,
gastrointestinal surgery) that may interfere with drug absorption, distribution,
metabolism, or excretion.

- Subject has a history of malignancy within 5 years, or current malignancy, except for
non-melanoma skin cancer.

- Subject has a history of drug or alcohol abuse or dependence in the past 6 months or
positive urine drug and alcohol test at screening.

- Subject is participating in, has participated in, or plans to participate in any
investigational drug study within 30 days prior to screening until the end of this
study.

- Subject has history of circadian rhythm disorder, or travels across >3 time zones on a
regular basis.

- Subject is known to be seropositive for Human Immunodeficiency Virus (HIV).

- Subject has used any drugs known or suspected to affect hepatic or renal clearance
capacity within a period of 30 days prior to screening.

- Subject is unwilling to refrain from drinking alcoholic beverages during study
participation.

- Subject is a rotating or third/night shift worker.

- Subject is a staff member or relative of a staff member.