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Insomnia clinical trials

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NCT ID: NCT00770692 Completed - Insomnia Clinical Trials

A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)

Start date: October 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.

NCT ID: NCT00768781 Completed - Insomnia Clinical Trials

Mindfulness-Based Approaches to Insomnia

Start date: November 2008
Phase: Phase 2
Study type: Interventional

The overall goal of this project is to evaluate the evidence for the efficacy of two mindfulness-based interventions, mindfulness-based therapy for insomnia (MBT-I) and mindfulness-based stress reduction (MBSR), for reducing arousal and improving sleep among individuals with psychophysiological insomnia. Specific Aim 1: To obtain evidence for the relative effects of MBT-I and MBSR compared to a delayed-treatment control condition followed by behavior therapy for insomnia (BT-I) on arousal levels. It is hypothesized that MBSR and MBT-I will be superior to the control condition at reducing arousal levels. Specific Aim 2: To obtain evidence for the relative effects of MBT-I, MBSR, and the delayed-treatment control on sleep. It is hypothesized that MBT-I will be superior to the MBSR and control conditions at improving sleep parameters. Specific Aim 3: To investigate the relationship between measures of arousal (self-report and objective measures) and sleep (self-report and objective measures) to enhance the understanding of the role of arousal in psychophysiological insomnia.

NCT ID: NCT00765752 Completed - Insomnia Clinical Trials

Cortical GABA Concentrations in Insomnia

Start date: November 2007
Phase: N/A
Study type: Observational

Disturbances in the amino acid neurotransmitter (AANt), gamma-amino butyric acid (GABA) function are hypothesized to contribute to the neurobiology of Major Depressive Disorder (MDD) and insomnia. The principal objective of this project is to use magnetic resonance spectroscopy (MRS) to provide the first in vivo characterization of cortical GABA levels in individuals with primary insomnia, and to determine whether subjects with MDD, achieving a partial response with selective serotonin reuptake inhibitor treatment but still experiencing significant residual symptoms including insomnia, have altered levels of this neurotransmitter. The investigators are also exploring the correlation between cortical AANt levels and abnormalities in sleep parameters in primary insomnia and as a residual symptom of major depression.

NCT ID: NCT00748592 Withdrawn - Insomnia Clinical Trials

A Dose-Ranging, Multicenter Polysomnography Trial of PD 0200390 in Elderly Subjects With Primary Insomnia

Start date: January 2009
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.

NCT ID: NCT00746239 Terminated - Insomnia Clinical Trials

Ramelteon for Sleep Initiation Insomnia in Individuals With Panic Disorder Who Are Also on Escitalopram for Anxiety

Start date: August 2008
Phase: N/A
Study type: Interventional

Almost 80% of panic disorder patients report difficulty sleeping. Sleep disturbances in turn may exacerbate underlying anxiety/panic attacks. Moreover, individuals with insomnia (sleep disturbance) are at higher risk of developing a new anxiety disorder. Therefore it is expected that improving sleep quality with medications along with other medications to treat anxiety component of panic disorder might be helpful. However, there is lack of pharmacological studies examining the effects of improving sleep disturbances with medications in panic disorder patients, which is a critical problem for providing optimal care to these patients. The objective of this proposal is to determine the effects of ramelteon (FDA approved for insomnia) on sleep disturbances in Panic disorder patients who are on escitalopram for underlying anxiety.

NCT ID: NCT00734799 Completed - Insomnia Clinical Trials

Treating Co-Morbid Sleep Difficulties in Veterans With Posttraumatic Stress Disorder (PTSD): A Pilot Study

Start date: January 2008
Phase: N/A
Study type: Interventional

A substantial number of US Veterans are suffering from Posttraumatic Stress Disorder (PTSD) following deployment in recent military conflicts, and sleep disturbance is a primary complaint of Veterans presenting to the VA with PTSD. Veterans with PTSD have more self-reported and physician-rated health problems, and health status is associated with PTSD symptom severity. Most Veterans meeting criteria for PTSD report difficulty initiating or maintaining sleep (70-91%), and increased PTSD severity is associated with increased sleep disturbance. Even after receiving treatment for PTSD, Veterans continue to experience residual insomnia at a rate of about 50%, in spite of having achieved PTSD remission. There are currently no PTSD-specific sleep interventions available, excepting an intervention that is specific to nightmares. Given the prevalence of sleep disturbance in Veterans with PTSD, the absence of interventions for PTSD-related sleep problems, and the increasing number of post-deployment Veterans with trauma-related sleep difficulties, such interventions are desperately needed. In this study, we will test the effectiveness of a multi-component cognitive-behavioral sleep intervention for PTSD that targets both nightmares and insomnia for improving the overall sleep experience of Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) Veterans with PTSD who are also receiving usual care. The primary objective is to pilot test the intervention for efficacy in reducing sleep disturbance. The secondary objective is to examine the relative impact of the intervention on PTSD symptoms. The project is a prospective, randomized, clinical intervention trial. Participants will be randomly assigned to a multi-component cognitive-behavioral sleep intervention for PTSD + Usual Care, or Usual Care alone. We are hypothesizing that 1) Veterans receiving the sleep intervention plus usual care will produce greater improvements (reduced total wake time, increased sleep efficiency, etc) in subjective sleep measures than will Usual Care alone; 2) Veterans receiving the sleep intervention plus usual care will produce greater improvements in nightmare frequency and severity than will Usual Care alone; and 3) the relationship between PTSD symptoms and treatment group will be significantly related to sleep quality in the period intervening baseline and follow-up.

NCT ID: NCT00724282 Completed - Insulin Resistance Clinical Trials

Treatment of Insomnia and Glucose Metabolism

Start date: April 2008
Phase: Phase 4
Study type: Interventional

Available data suggest that obtaining adequate sleep is associated with a better ability of the body to use carbohydrates as a source of energy and a lower risk of developing diabetes. The sleeping pill, Eszopiclone (Lunesta), has been approved by the Food and Drug Administration for the treatment of people who complain of trouble falling or staying asleep. This study will examine the hypothesis that the use of Eszopiclone (Lunesta) to improve the sleep of people with insomnia may also improve the use of sugar in their body.

NCT ID: NCT00723970 Completed - Clinical trials for Major Depressive Disorder

Quetiapine Extended Release (XR) for the Treatment of Menopausal Depression

Start date: June 2007
Phase: Phase 4
Study type: Interventional

The study was designed to examine the efficacy and tolerability of quetiapine XR for the treatment of women who suffer from depression in the context of the menopausal transition and postmenopausal years. Besides the improvement of depressive symptoms, the investigators are interested in examining the impact of this medication on vasomotor symptoms (hot flashes, night sweats), sleep and overall quality of life.

NCT ID: NCT00723580 Completed - Insomnia Clinical Trials

Actigraphic Analysis of Treatment Response

Start date: May 2008
Phase: N/A
Study type: Interventional

The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.

NCT ID: NCT00722306 Completed - Insomnia Clinical Trials

A Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers

Start date: May 2008
Phase: Phase 1
Study type: Interventional

To determine the mass balance of PD 0200390