Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon (NCT00642694) | Clinical Trial Compass
TerminatedPhase 3
Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon
Stopped: Enrollment discontinued based on mutually agreed upon decision by PI and funding sponsor
United States29 participantsStarted 2007-05
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Percentage of Remitters on IDS-C30 at Week 12
Timeframe: 12 Weeks
Trial details
NCT IDNCT00642694
SponsorUniversity of Texas Southwestern Medical Center