Clinical trial NCT00642694: Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon
Official title: Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
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
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2008-03-25
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Percentage of Remitters on IDS-C30 at Week 12
timeFrame: 12 Weeks
Secondary outcomes:
measure: Sleep Latency
timeFrame: 12 weeks
measure: Short-Form Health Survey - Version 2 (SF-36)
timeFrame: 12 Weeks
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
timeFrame: 12 Weeks
measure: Social Adjustment Scale - Self-Report (SAS-SR)
timeFrame: 12 Weeks
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: 12 Weeks
measure: Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: 12 Weeks
measure: Patient Perception of Benefits of Care (PPBC)
timeFrame: 12 Weeks
measure: Hamilton Rating Scale for Depression 17-item
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
References: