Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon

NCT ID: NCT00642694

Last Updated: 2019-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-05-31

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.

Conditions

Major Depressive Disorder; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

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

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

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

Ramelteon

Intervention Type: DRUG

Ramelteon 8 mg qd

2

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

Group Type: PLACEBO_COMPARATOR

Escitalopram

Intervention Type: DRUG

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

Placebo

Intervention Type: OTHER

Matching placebo qd

Interventions

Escitalopram

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

Intervention Type: DRUG

Ramelteon

Ramelteon 8 mg qd

Intervention Type: DRUG

Placebo

Matching placebo qd

Intervention Type: OTHER

Other Intervention Names

Lexapro (escitalopram); Rozerem (Ramelteon)

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Prabha Sunderajan

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Countries

United States

Related Links

http://www.utsouthwestern.edu/utsw/home/.research/depression

Mood Disorders Research Program and Clinic

Other Identifiers

112006-017

Identifier Type: -

Identifier Source: secondary_id

06-031R

Identifier Type: -

Identifier Source: org_study_id