Brain Mechanisms and Targeting Insomnia in Major Depression

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Major Depressive Disorder, Insomnia

In brief

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 this acceleration in response, though preliminary findings support the hypothesis that early restoration of sleep may facilitate BDNF-based effects of antidepressant medications. The optimal duration of co-treatment is also unknown. This study will test specific hypotheses about brain mechanisms and evaluate the effects of continued eszopiclone beyond the time window when response acceleration should be observed.

Key facts

Study ID

NCT00628914

Run by

University of California, Los Angeles

People needed

60

Starts

2008-05-01

Expected to finish

2010-02-01

Last updated by the study team

2010-08-20

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Semel Institute for Neuroscience and Human Behavior at UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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