Paroxetine in the Treatment of Chronic Primary Insomnia

University of Pittsburgh66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Primary Insomnia Depression

Interventions

paroxetineDRUG

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Pittsubrgh Medical Center

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Polysomnographic Sleep measures

Pittsburgh Sleep Quality Index and Sleep Diary

Daytime well being on the Profile of Mood States

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

Data from ClinicalTrials.gov

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