Brain Mechanisms and Targeting Insomnia in Major Depression

NCT00628914 | Unknown Phase 4

• 2 other identifiers: ESRC97307-11-013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Major Depressive Disorder; Insomnia

Keywords

Major Depressive Disorder; Insomnia; Escitalopram; Lexapro; Eszopiclone; Lunesta; Cordance

Outcome Measures

Primary Outcomes (3)

• Change in cordance value

  Visits 2-9

• Change in cordance value

  Visit 11

• Change in cordance value

  Visit 13

Secondary Outcomes (7)

• Depression symptom severity

  each visit

• Serum BDNF

  visits 2-9

• Cognitive testing

  visits 2-7

• Serum BDNF

  Visit 11

• Serum BDNF

  Visit 13

Study Arms (3)

1

EXPERIMENTAL

Open label escitalopram plus eszopiclone for 8 weeks

Drug: escitalopram and eszopiclone

2

OTHER

Escitalopram and eszopiclone for initial 4 weeks, then switch to escitalopram and placebo for final 4 weeks.

Drug: Escitalopram, eszopiclone, and placebo

3

PLACEBO COMPARATOR

Escitalopram plus placebo for 8 weeks

Drug: Escitalopram

Interventions

escitalopram and eszopiclone DRUG

escitalopram 10mg tabs QD and eszopiclone 3 mg tabs QD for 8 weeks

Also known as: Lexapro, Lunesta

1

Escitalopram, eszopiclone, and placebo DRUG

Escitalopram 10mg tabs QD for 8 weeks; Eszopiclone 3mg tabs QD for initial 4 weeks then placebo tabs QD for final 4 weeks

Also known as: Lexapro, Lunesta

2

Escitalopram DRUG

Escitalopram 10mg tabs QD and placebo tabs QD for 8 weeks

Also known as: Lexapro

3

Eligibility Criteria

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

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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Semel Institute for Neuroscience and Human Behavior at UCLA

Los Angeles, California, 90024, United States

Location

Related Links

• UCLA Depression Research Program
• UCLA Laboratory of Brain, Behavior, and Pharmacology

MeSH Terms

Conditions

Depressive Disorder, Major; Sleep Initiation and Maintenance Disorders

Interventions

Escitalopram; Eszopiclone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Pyrazines; Pyridines

Study Officials

• Ian A Cook, MD

  Semel Institute for Neuroscience and Human Behavior at UCLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: March 5, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: February 1, 2010
• Last Updated: August 20, 2010

Record last verified: 2010-07

Locations

US (1)