Status:
UNKNOWN
Brain Mechanisms and Targeting Insomnia in Major Depression
Lead Sponsor:
University of California, Los Angeles
Conditions:
Major Depressive Disorder
Insomnia
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief Summary
Preliminary studies suggest that the response to antidepressant medication can be accelerated by targeting insomnia with adjunctive use of eszopiclone. It is not yet known what mechanism(s) support th...
Detailed Description
A critical challenge in the management of major depressive disorder (MDD) is the delay between initiating treatment with an antidepressant medication and clinical improvement. Preliminary studies (Fav...
Eligibility Criteria
Inclusion
- Outpatients with non-psychotic, unipolar Major Depressive Disorder (MDD).
- A score of \>14 on the HAM-D17.
- Presence of insomnia, manifest by a total score of ≥ 4 combining all three sleep disturbance items on the HAM-D17 scale.
- Age range: 18-64.
- Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm.
Exclusion
- Patient is mentally or legally incapacitated, unable to give informed consent.
- Patients who have a lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder, MDD with psychotic features, or dementia (any etiology).
- Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
- Patients with a current diagnosis of anorexia nervosa, bulimia nervosa, or obsessive compulsive disorder.
- Patients who have met diagnostic criteria for any current substance abuse disorder at any time in the 6 months prior to enrollment.
- Insomnia symptoms that have not responded to a previous trial of a sedativehypnotic prescription medication.
- Any history of seizures, brain surgery, skull fracture, significant head trauma, or previous abnormal EEG.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00628914
Start Date
May 1 2008
End Date
February 1 2010
Last Update
August 20 2010
Active Locations (1)
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1
Semel Institute for Neuroscience and Human Behavior at UCLA
Los Angeles, California, United States, 90024