Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon - Full Text View

Sponsor:	University of Texas Southwestern Medical Center
Collaborator:	Takeda Pharmaceuticals North America, Inc.
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00642694

Purpose

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.

Condition	Intervention	Phase
Major Depressive Disorder Insomnia	Drug: Escitalopram + Ramelteon Drug: Escitalopram + Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Ramelteon Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:

Remission as defined by a score of <12 on the Inventory of Depressive Symptoms, Clinician-Rated version (IDS-C30; Rush et al 1986; Rush et al., 1996) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of sleep i.e. total sleep time and decreased latency of sleep onset as defined by subjective sleep diaries and sleep actigraph [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Psychosocial measures i.e. SF health survey, QLESQ, Social Adjustment Scale Self Report, Work and Social Adjustment Scale, Work Productivity and Activity Impairment Questionaire, and the Patients Perception of Benefits of Care. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Hamilton Rating Scale for Depression 17-item [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	May 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Escitalopram + Ramelteon	Drug: Escitalopram + Ramelteon Escitalopram 10 or 20mg qd based on symptoms at patient visit Ramelteon 8mg qd Other Name: Lexapro (escitalopram) and Rozerem (Ramelteon)
Placebo Comparator: 2 Escitalopram + Placebo	Drug: Escitalopram + Placebo Escitalopram 10 or 20 mg qd based on symptoms at study visit Other Name: Lexapro (escitalopram)

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642694

Locations

United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 752390-9119

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Takeda Pharmaceuticals North America, Inc.

More Information

Additional Information:

Mood Disorders Research Program and Clinic This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Prabha Sunderajan, M.D./ Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00642694 History of Changes
Other Study ID Numbers:	06-031R, 112006-017
Study First Received:	March 19, 2008
Last Updated:	November 2, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:

MDD
Major Depressive Disorder
Depression
Initial Insomnia
sleep

difficulty sleeping
down
sad
Major Depressive Disorder(MDD) and initial insomnia

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Sleep Initiation and Maintenance Disorders
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 12, 2012