Clinical trial NCT00178048: Paroxetine in the Treatment of Chronic Primary Insomnia
Official title: Paroxetine in the Treatment of Chronic Primary Insomnia: A Double-Blind, Randomized, Placebo-Controlled Study of Efficacy Over Six Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Insomnia
Depression
Keywords: primary insomnia
insomnia
depression
late life
elderly
sleep disorders
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-15
Enrollment: 66
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 55 or older
* Diagnosis of chronic primary insomnia
* Score of 8 or higher on the Pittsburgh Sleep Quality Index
* free of all antidepressants and benzodiazepine for two weeks

Exclusion Criteria:

* lifetime diagnosis of any psychotic disorder,or bipolar disorder.
* DSM-IV diagnosis of dysthymia or generalized anxiety disorder
* Diagnosis of major depression within the past 6 months
* Alcohol or drug abuse within the past 6 months
* Contraindication to SSRI therapy
* History of seizure disorder
* Baseline apnea/hypopnea index score greater than 15
* Hyponatremia

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Polysomnographic Sleep measures
measure: Pittsburgh Sleep Quality Index and Sleep Diary
measure: Daytime well being on the Profile of Mood States
measure: Daytime functioning on the Sickness Impact Profile, Medical Outcomes Study (SF-36), and UKU
measure: 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
measure: 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.
measure: SCID
measure: Sleep Hygiene Awareness and Practices Scale
measure: Diagnostic Response: Clinical Global Impressions Scale
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsubrgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Charles F Reynolds III, M.D.
role: PRINCIPAL_INVESTIGATOR
References: