Phase 4 N=50 Randomized Single-blind Treatment

Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder

Seasonal Affective Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00502320 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Oct 2009

Primary outcome: Primary: Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) — 11.56; 11.45; 9.52; 8.67 scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ramelteon (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Lehigh Valley Hospital
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI)	11.56; 11.45; 9.52; 8.67; 7.57; 8.62	—
SECONDARY Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Zung Depression Scale (ZDS)	63.06; 58.63; 54.35; 56.40; 53.51; 58.59	—
SECONDARY Depressive Symptoms at Baseline and Measured Monthly, as Measured by the Structured Interview Guide for the Hamilton Depression Rating - Seasonal Affective Disorder (SIGH-SAD)	22.68; 19.99; 16.16; 15.97; 14.81; 19.47	—

Summary

The purpose of this study is to determine whether treating sleep difficulties in patients with seasonal affective disorder also improves their depressive symptoms.

Eligibility Criteria

Inclusion Criteria

Male or female age 18-65 yrs.
A diagnosis of seasonal affective disorder
A Pittsburgh Sleep Quality Index >5
English speaking
Be able to sign informed consent

Exclusion Criteria

Active substance abuse
Current psychotic symptoms
Severe personality disorders
Primary sleep disorders
Severe chronic obstructive pulmonary disease (COPD)
Prescription fluvoxamine(Luvox) use

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00502320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.