Characteristics of Sleep Patterns in Young Adults With and Without Insomnia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00177216
First received: September 12, 2005
Last updated: April 30, 2009
Last verified: April 2009
  Purpose

This study will compare the symptoms, experiences, and laboratory sleep characteristics of young adults with and without insomnia.


Condition Intervention Phase
Sleep Disorders
Drug: Escitalopram
Drug: Zolpidem
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychobiology and Treatment Response in Primary Insomnia

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Pittsburgh Sleep Quality Index score, Sleep Diary data, and polysomnographic sleep studies [ Time Frame: Measured at baseline and Week 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-report sleep diaries, improvement scales, Pittsburgh Insomnia Rating Scale, Arousal Predisposition Scale, and the Inventory of Depressive Symptomatology [ Time Frame: Measured weekly for 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 99
Study Start Date: February 2002
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants receiving an enzodiazepine receptor agonist (BzRA), zolpidem
Drug: Zolpidem
Benzodiazepine receptor agonist (BzRA), zolpidem, treatment for insomnia
Experimental: 2
Participants receiving an antidepressant, escitalopram
Drug: Escitalopram
Antidepressant, escitalopram, treatment for insomnia
Placebo Comparator: 3
Participants receiving a placebo
Drug: Placebo
Placebo control

Detailed Description:

The overall aim of this research study is to compare the symptoms, experiences and laboratory sleep characteristics of young adults with and without insomnia. Insomnia is a pattern of difficulty falling asleep, staying asleep or feeling poorly rested despite an adequate amount of time for sleep, which occurs nearly every night for one month or longer. For those with insomnia, we will look at the effects of an intervention with one of two medications (escitalopram or zolpidem) or an inactive pill (placebo). This intervention will be followed by re-evaluation of symptoms, experiences and laboratory sleep characteristics. The three hypotheses being investigated are: compared to control subjects, those with insomnia will demonstrate affective disturbance and heightened arousal; the different medications will have different degrees of effect on the two dimensions being measured (affective disturbance and heightened arousal); and PET scans will reveal different patterns of activity in the brains of groups of people with insomnia.

We will specifically focus on the syndrome of Primary Insomnia (PI), defined by DSM-IV as insomnia that lasts for at least one month and causes significant impairment or distress. PI excludes insomnia that occurs exclusively during the course of another sleep, mental, substance-induced, or medical disorder. Insomnia is a significant public health problem because of its prevalence, morbidity, and the risk it poses for the development of subsequent mental disorders, particularly depressive and anxiety disorders. Understanding the psychobiology of primary insomnia is a critical step toward addressing questions regarding its relationships with mood and anxiety disorders.

Our model of insomnia builds on two major concepts running through previous insomnia research, affective disturbance and heightened arousal, as driving factors for the sleep-wake disturbances that define PI. Implicit in this model is that individuals with PI have different degrees of each dysfunction, which accounts for their heterogeneity of clinical symptoms. Contemporary theories of affect structure suggest that these two dimensions may be orthogonal in pure form, but are nevertheless related in clinical conditions characterized by mixed anxiety-depression, such as PI. Measures of affective disturbance and arousal in this study will include questionnaires, diary-based assessments, and physiological measures.

Pharmacological treatment probes may help to further distinguish the roles of affective disturbance and heightened arousal in insomnia. We will use a benzodiazepine receptor agonist (BzRA), zolpidem, and an antidepressant, escitalopram. BzRA potentiate the effects of GABA (1), but have minimal direct activity at any other receptor types. They are efficacious treatments for insomnia (2-4), but have little effect on mood. We chose zolpidem because it is relatively specific for hypnotic versus anxiolytic or other actions (5), because it is the most widely-prescribed BzRA hypnotic, and because it is well-tolerated (6). Clinically-effective doses of even "nonsedating" antidepressants can also improve symptoms in PI (7), suggesting that direct sedation is not their only mechanism for improving insomnia. We chose escitalopram because it is neither strongly alerting nor sedating in clinical and polysomnographic studies. This "sleep-neutral" profile will allow us to use it for its effects on affective disturbance, rather than its nonspecific sedating properties. Escitalopram's specific effect on serotonin reuptake blockade and its lack of affinity for Bz receptors distinguish it from zolpidem as a pharmacologic probe.

Functional neuroimaging studies in wakefulness and sleep may also help to identify the substrate of affective disturbance and heightened arousal in insomnia. Affective disturbance in the form of MDD is associated with alterations in both regional deactivation patterns during NREM sleep, and regional activation patterns during REM sleep. These observations suggest that a sleep-wake functional neuroimaging paradigm in insomnia patients, in conjunction with behavioral measures, may help to identify which brain systems mediate heightened arousal and affective disturbance, and how these systems interact.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Physically healthy
  • Meets DSM-IV criteria for primary insomnia
  • For subjects interested in PET study only: right-handedness

Exclusion Criteria:

  • Currently taking antidepressants, antianxiety medications or medications for sleep disorders
  • Currently experiencing symptoms of psychiatric disorders such as major depressive disorder, bipolar disorder, generalized anxiety disorder
  • Significant or unstable acute or chronic medical conditions, such as seizure disorder, tumor, liver disease, active peptic ulcer disease, arthritis, irritable bowel disease
  • Meets DSM-IV criteria for sleep apnea or periodic limb movement disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177216

Locations
United States, Pennsylvania
Western Psychiatric Institute and Clinic/ University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Investigators
Principal Investigator: Daniel J. Buysse, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Daniel J. Buysse, MD, University of Pittsburgh School of Medicine
ClinicalTrials.gov Identifier: NCT00177216     History of Changes
Other Study ID Numbers: R01 MH24652, 010807, DATR A2-AID
Study First Received: September 12, 2005
Last Updated: April 30, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Primary Insomnia
Insomnia
Placebo-Controlled
Double-Blind
Polysomnography
PET Studies
Escitalopram
Zolpidem

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders
Parasomnias
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Antidepressive Agents
Citalopram
Dexetimide
Zolpidem
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on July 10, 2014