Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon
Condition: Major Depressive Disorder; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Escitalopram; Ramelteon; Placebo
Intervention description: Escitalopram 10 or 20mg qd based on symptoms at patient visit; Ramelteon 8 mg qd; Matching placebo qd
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: MDD; Major Depressive Disorder; Depression; Initial Insomnia; sleep; difficulty sleeping; down; sad; Major Depressive Disorder(MDD) and initial insomnia

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability and willingness to provide written informed consent.

          -  Primary diagnosis of MDD with initial insomnia.

          -  Age 18-70.

          -  Screening HRSD17 score greater than or equal to 16 or CGI-S score of at least 4.

          -  Subjective report of difficulties with initial insomnia with a score of 2 or greater
             on the IDS-C30 item addressing this symptom (#1). Middle and late insomnia may also be
             present so long as initial insomnia is present.

        Exclusion Criteria:

          -  Presence of significant comorbid medical condition based on laboratory test, physician
             information, or evidence at examination; this includes severe sleep apnea, seizure
             disorder, or chronic obstructive pulmonary disease (COPD).

          -  Patient report or evidence (based on physical examination or laboratory tests) of
             significant medical abnormalities; this includes severe sleep apnea, seizure disorder,
             or COPD.

          -  Presence of other psychological disorders, including depression due to other comorbid
             conditions, currently suicidal or high suicide risk, current or past psychotic
             disorders of any type, bipolar disorder (I, II, or NOS), schizophrenia, or
             schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or
             substance abuse within the last 6 months, or patients with comorbid psychiatric
             conditions that are relative or absolute contraindications to the use of escitalopram
             or ramelteon.

          -  Concomitant (i.e. within 2 weeks; 4 weeks for fluoxetine or MAOIs) pharmacological or
             psychotherapeutic treatment including but not limited to anxiolytics, neuroleptics,
             mood stabilizers, sleep aids including over the counter melatonin, and/or other agents
             without proven antidepressant efficacy, cognitive behavioral therapy; current use of
             other medications that would be contraindicated with ramelteon or escitalopram,, as
             determined by the study doctor.

          -  Failure to respond to 2 adequate courses of SSRI class antidepressant in the current
             episode (as measured by the Antidepressant Treatment History Form).

          -  Hospitalization for mental illness within the past year.

          -  For women, currently pregnant, planning to become pregnant in the next year, or
             breastfeeding.

          -  Patient does not speak English. (Patient needs to be fluent in written and oral
             English because not all assessments are available and/or validated in languages other
             than English).