Brain Mechanisms and Targeting Insomnia in Major Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00628914
• Date of registration: 25/02/2008
• Prospective Registration: Yes
• Primary sponsor: University of California, Los Angeles
• Public title: Brain Mechanisms and Targeting Insomnia in Major Depression
• Scientific title: Brain Mechanisms and Targeting Insomnia in Major Depression
• Date of first enrolment: May 2008
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00628914
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Ian A Cook, MD
• Affiliation: Semel Institute for Neuroscience and Human Behavior at UCLA

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Insomnia

Intervention(s)

Drug: Escitalopram

Drug: escitalopram and eszopiclone

Drug: Escitalopram, eszopiclone, and placebo

Primary Outcome(s)

Change in cordance value [Time Frame: Visit 13]

Change in cordance value [Time Frame: Visit 11]

Change in cordance value [Time Frame: Visits 2-9]

Secondary Outcome(s)

Serum BDNF [Time Frame: Visit 13]

Depression symptom severity [Time Frame: each visit]

Cognitive testing [Time Frame: Visit 9]

Serum BDNF [Time Frame: visits 2-9]

Cognitive testing [Time Frame: visits 2-7]

Cognitive testing [Time Frame: Visit 13]

Serum BDNF [Time Frame: Visit 11]

Secondary ID(s)

07-11-013

ESRC973

Source(s) of Monetary Support

Please refer to primary and secondary sponsors