Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon

NCT00642694 | Terminated Phase 3 Results

• 2 other identifiers: 06-031R112006-017
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Remitters on IDS-C30 at Week 12

  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

  12 Weeks

Secondary Outcomes (8)

• Sleep Latency

  12 weeks

• Short-Form Health Survey - Version 2 (SF-36)

  12 Weeks

• Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

  12 Weeks

• Social Adjustment Scale - Self-Report (SAS-SR)

  12 Weeks

• Work and Social Adjustment Scale (WSAS)

  12 Weeks

Study Arms (2)

1

EXPERIMENTAL

Escitalopram tablets (starting dose of 10 mg with a maximum dose of 20 mg daily) + Ramelteon (One 8 mg capsule at night)

Drug: Escitalopram; Drug: Ramelteon

2

PLACEBO COMPARATOR

Escitalopram tablets (starting dose of 10 mg with a maximum dose of 20 mg daily) + Matching Placebo (One capsule at night)

Drug: Escitalopram; Other: Placebo

Interventions

Escitalopram DRUG

Escitalopram 10 or 20mg qd based on symptoms at patient visit

Also known as: Lexapro (escitalopram)

1; 2

Ramelteon DRUG

Ramelteon 8 mg qd

Also known as: Rozerem (Ramelteon)

1

Placebo OTHER

Matching placebo qd

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 752390-9119, United States

Location

Related Links

• Mood Disorders Research Program and Clinic

MeSH Terms

Conditions

Depressive Disorder, Major; Sleep Initiation and Maintenance Disorders; Depression; Parasomnias

Interventions

Escitalopram; ramelteon

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr.Prabha Sunderajan- Assistant Professor
• Organization: UT Southwestern Medical Center

psunderajan@utsouthwestern.edu

214-645-6964

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 25, 2008
• Study Start: May 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 26, 2019
• Results First Posted: October 26, 2012

Record last verified: 2019-07

Locations

US (1)