Primary InsomniaPhase 4NCT00178048
Paroxetine in the Treatment of Chronic Primary Insomnia
A Phase 4 study testing paroxetine in people with Primary Insomnia and Depression, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Primary Insomnia, Depression
- What is being tested?
- paroxetine
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 1998to Dec 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Pittsubrgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Paroxetine in the Treatment of Chronic Primary Insomnia: A Double-Blind, Randomized, Placebo-Controlled Study of Efficacy Over Six Weeks
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.
Read the 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.
- Conditions
- Primary Insomnia, Depression
- Being tested
- paroxetine
- Keywords
- primary insomnia, insomnia, depression, late life, elderly, sleep disorders
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paroxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (9)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 1998
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 66 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Charles F Reynolds III, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178048
- Sponsor's protocol ID
- 970357
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paroxetine in the Treatment of Chronic Primary Insomnia: A Double-Blind, Randomized, Placebo-Controlled Study of Efficacy Over Six Weeks
- ClinicalTrials.gov ID
- NCT00178048
- Acronym / sponsor ID
- 970357
- Conditions
- Primary Insomnia, Depression
- Keywords
- primary insomnia, insomnia, depression, late life, elderly, sleep disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 1998
- Study completion
- Dec 2003
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paroxetine | Drug | – |
Primary outcome
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
9 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles F Reynolds III, M.D. principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing paroxetine in people with Primary Insomnia and Depression, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2005.