Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
The goal of the study is to examine the role of paroxetine, an antidepressant medication, in the acute and continuation treatment of insomnia. Primary insomnia is a type of insomnia not directly resulting from general medical, chemical, or psychiatric conditions.
The primary aim of this study is to demonstrate the role of paroxetine in the acute treatment of chronic primary insomnia. Paroxetine taken on a nightly basis in combination with sleep hygiene therapy will produce a greater number of diagnostic responders in acute treatment, compared to a placebo and sleep hygiene control condition, in a randomized, double-blinded, six-week acute treatment trial. EEG sleep, sleep quality, and daytime well-being, and daytime functioning will also show superior treatment effects during acute treatment with paroxetine plus sleep hygiene, as compared with the placebo control condition.
A total of 66 patients with primary insomnia, as defined by DSM-IV criteria, will be randomized (1:1) to receive paroxetine plus sleep hygiene therapy (P+SH-a) or placebo plus sleep hygiene therapy (PL+SH-a) in weekly acute treatment sessions evolving over a six-week interval in a double-blinded, parallel group design.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paroxetine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Paroxetine in combination with sleep hygiene therapy will produce a greater number of responders in acute treatment, compared to a placebo and sleep hygiene condition, in a randomized, double-blinded, six-week acute trial |
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnographic Sleep measures | ||
| Pittsburgh Sleep Quality Index and Sleep Diary | ||
| Daytime well being on the Profile of Mood States |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles F Reynolds III, M.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States | ||
| University of Pittsubrgh Medical Center |
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003863 | Depression |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Daytime functioning on the Sickness Impact Profile, Medical Outcomes Study (SF-36), and UKU |
| Stress measures: Schedule of Recent Events, Perceived Stress Scale, Impact of Life Events Scale, Ways of Coping Inventory, Multidimensional Fatigue Inventory, and Brief Symptom Inventory |
| Psychophysiological arousal and mood measures collected at each sleep study: the Pres-Sleep Arousal Scale, Spielman Insomnia Symptom Questionnaire, Pittsburgh Insomnia Rating Scale, and the Pre-Sleep Experience Questionnaire. |
| SCID |
| Sleep Hygiene Awareness and Practices Scale |
| Diagnostic Response: Clinical Global Impressions Scale |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |