Expired Study
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Dallas, Texas


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.

Study summary:

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.


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).

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:


Brief Title:

Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon

Official Title:

Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon

Overall Status:


Study Phase:

Phase 3



Minimum Age:

18 Years

Maximum Age:

70 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Texas Southwestern Medical Center

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Enrollment discontinued based on mutually ag

Study Type:


Study Design:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Study Dates

Start Date:May 2007
Completion Date:May 2010
Completion Type:Actual
Primary Completion Date:May 2010
Primary Completion Type:Actual
Verification Date:July 2019
Last Changed Date:July 3, 2019
First Received Date:March 19, 2008
First Results Date:March 29, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Hamilton Rating Scale for Depression 17-item
Time Frame:12 Weeks
Safety Issues:False
Description:The Hamilton Rating Scale for Depression is a clinician-administered rating scale that assesses severity of depressive symptoms and is one of the most widely used and validated symptom severity measures for depression. Each of the 17 items is rated by the
Outcome Type:Secondary Outcome
Measure:Patient Perception of Benefits of Care (PPBC)
Time Frame:12 Weeks
Safety Issues:False
Description:The Patient Perception of Benefits of Care (PPBC) assesses how much patients believe their quality of life will improve in response to medical care or treatment. Scores range between 10-50, with lower scores indicating greater belief that treatment will i
Outcome Type:Secondary Outcome
Measure:Work Productivity and Activity Impairment Questionnaire (WPAI)
Time Frame:12 Weeks
Safety Issues:False
Description:The Work Productivity and Activity Impairment Questionnaire (WPAI) was used to report impairment while working or performing usual daily activities as a result of health problems. The activity impairment item (#6 of WPAI) is rated on a scale of 0-10, with
Outcome Type:Secondary Outcome
Measure:Work and Social Adjustment Scale (WSAS)
Time Frame:12 Weeks
Safety Issues:False
Description:The Work and Social Adjustment Scale (WSAS) is 5-item self-report measure designed to identify functional impairment that is attributed to an identified problem or condition. and has been used in studies of depression and anxiety. Scores range between 0-4
Outcome Type:Secondary Outcome
Measure:Social Adjustment Scale - Self-Report (SAS-SR)
Time Frame:12 Weeks
Safety Issues:False
Description:The Social Adjustment Scale - Self-Report (SAS-SR) is a 54-item self-report measure of instrumental and expressive role performance. Each item is rated on a 5-point scale, and a mean item score (ranging from 1-5) is obtained, with higher scores indicating
Outcome Type:Secondary Outcome
Measure:Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time Frame:12 Weeks
Safety Issues:False
Description:The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) measures satisfaction and enjoyment in various domains of functioning: physical health, feelings, work, household duties, school/course work, leisure time activities, social relations,
Outcome Type:Secondary Outcome
Measure:Short-Form Health Survey - Version 2 (SF-36)
Time Frame:12 Weeks
Safety Issues:False
Description:The Short-Form Health Survey - version 2 (SF-36) is a self-report inventory measuring different domains of health-related quality of life: Physical Functioning, Physical Role Functioning, Bodily Pain, General Health, Vitality, Social Functioning, Emotiona
Outcome Type:Secondary Outcome
Measure:Sleep Latency
Time Frame:12 weeks
Safety Issues:False
Description:Number of minutes until fell asleep
Outcome Type:Primary Outcome
Measure:Percentage of Remitters on IDS-C30 at Week 12
Time Frame:12 Weeks
Safety Issues:False
Description:Remission as defined by a score of <12 on the Inventory of Depressive Symptomatology, Clinician-Rated version (IDS-C30) at Week 12; minimum possible score = 0, maximum possible score = 84; higher scores indicate worse symptom severity

Study Interventions

Intervention Type:Drug
Description:Escitalopram 10 or 20mg qd based on symptoms at patient visit
Arm Name:1
Other Name:Lexapro (escitalopram)
Intervention Type:Drug
Description:Ramelteon 8 mg qd
Arm Name:1
Other Name:Rozerem (Ramelteon)
Intervention Type:Other
Description:Matching placebo qd
Arm Name:2

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:2
Description:Escitalopram tablets (starting dose of 10 mg with a maximum dose of 20 mg daily) + Matching Placebo (One capsule at night)
Study Arm Type:Experimental
Arm Name:1
Description:Escitalopram tablets (starting dose of 10 mg with a maximum dose of 20 mg daily) + Ramelteon (One 8 mg capsule at night)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Texas Southwestern Medical Center
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Takeda Pharmaceuticals North America, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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