Conditions: Major Depressive Disorder Insomnia
Keywords: MDD Major Depressive Disorder Depression Initial Insomnia sleep difficulty sleeping down sad Major Depressive Disorder(MDD) and initial insomnia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 29
Healthy volunteers: no

Brief summary:
Hypothesis I: Patients in the SSRI + ramelteon treatment group will achieve remission (defined as an IDS-C30 score of 11 or less) more quickly than those in the SSRI + placebo group.

Detailed description:
The primary objective of the study is to assess the time to remission in depression with initial insomnia using the SSRI antidepressant escitalopram combined with ramelteon or placebo. Patients will be assessed at each visit for depressive symptoms and insomnia, using the 30-item Inventory of Depressive Symptoms, Clinician-Rated version (IDS-C30; Rush et al 1986; Rush et al., 1996) as the primary outcome measure. The IDS self-report version will be used to assess self-reported changes in symptom severity. The 17 item Hamilton Rating Scale for Depression, (HRSD17; Hamilton, 1960) will also be administered, as it is the most commonly utilized depression symptom severity measure at this time.

Arms:
arm 1: Escitalopram tablets (starting dose of 10 mg with a maximum dose of 20 mg daily) + Ramelteon (One 8 mg capsule at night) arm 2: Escitalopram tablets (starting dose of 10 mg with a maximum dose of 20 mg daily) + Matching Placebo (One capsule at night)

Interventions: intervention 1: Escitalopram intervention 2: Ramelteon intervention 3: Placebo
Intervention descriptions: intervention 1: Escitalopram 10 or 20mg qd based on symptoms at patient visit intervention 2: Ramelteon 8 mg qd intervention 3: Matching placebo qd

Protocol document: