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Insomnia clinical trials

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NCT ID: NCT00488072 Active, not recruiting - Insomnia Clinical Trials

Effects of Mirtazapine on Appetite in Advanced Cancer Patients

Start date: September 20, 2006
Phase: Phase 2
Study type: Interventional

Primary objective: This is a preliminary study to determine if Mirtazapine in comparison to placebo will improve appetite in advanced cancer patients with anorexia and weight loss. An improvement of appetite is defined as a decrease of 2 in the appetite score from baseline on the Edmonton Symptom Assessment Scale (ESAS) at day 15 (+/-3 days). Secondary objective-A: To determine if Mirtazapine in comparison to placebo will improve insomnia ( as measured by Pittsburgh Sleep Quality Index) on day 15 ( +/- 3 days), and day 29 ( +/- 3 days) Secondary objective - B: To determine if Mirtazapine in comparison to placebo will improve other common symptoms such as pain, nausea and fatigue( as measured by ESAS), depression and anxiety ( as measured by Hospital Anxiety and Depression scale), and quality of life ( as measured by Functional Assessment of Anorexia/Cachexia Therapy ) in advanced cancer patients with anorexia/cachexia, on days 15 (+/-3 days), and 29 (+/-3 days) Other Objectives: To provide exploratory data on the effects of Mirtazapine on weight gain, and preservation/gain lean muscle mass ( anthropometric measurements and Bioelectric Impedance), on days 15 (+/-3 days), and 29 (+/-3 days). To provide exploratory data on the effects of a Mirtazapine dose increase to 30 mg on decreased side effects of drug and increased appetite on day 29 (+/-3 days).

NCT ID: NCT00484497 Completed - Insomnia Clinical Trials

Evaluation of a Food Supplement on Sleep Quality

Cyclamax
Start date: September 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.

NCT ID: NCT00482612 Completed - Insomnia Clinical Trials

Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)

RUBY
Start date: December 7, 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.

NCT ID: NCT00466193 Completed - Insomnia Clinical Trials

A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia

Start date: May 2007
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.

NCT ID: NCT00465972 Completed - HIV Infections Clinical Trials

The Treatment of Insomnia in Patients With HIV Disease

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

This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.

NCT ID: NCT00462618 Completed - Insomnia Clinical Trials

Group Cognitive Behavioral Therapy (CBT I) Vs. Quetiapine for Residual Insomnia Impairing Recovery Among Elderly With Stable Major Affective Disorders

Start date: April 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this pilot study is to assess feasibility and patient accessibility in order to design an adequately powered study to compare group cognitive behavioral therapy for insomnia (CBT-I) to quetiapine in non-demented patients aged 60 years or older with controlled bipolar disorder (I or II) or major depressive disorder who suffer from residual insomnia.

NCT ID: NCT00452179 Completed - Insomnia Clinical Trials

Safety and Efficacy Study of APD125 in Patient With Insomnia

Start date: February 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia.

NCT ID: NCT00435279 Completed - Clinical trials for Major Depressive Disorder

A Study of Eszopiclone Co-administered With Venlafaxine in Subjects With Major Depressive Disorder and Insomnia

Start date: June 2007
Phase: Phase 3
Study type: Interventional

To evaluate the antidepressant effect of adjunctive treatment with Eszopiclone in subjects receiving venlafaxine for the treatment of Major Depressive Disorder (MDD).

NCT ID: NCT00432198 Completed - Insomnia Clinical Trials

Zolpidem Postmarketing Study in Adolescent Patients With Insomnia

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

To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial

NCT ID: NCT00393874 Completed - Insomnia Clinical Trials

Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD)

EASI-P
Start date: October 2006
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate and compare the effects of experimental treatments aimed at improving insomnia and nightmares in men and women military veterans between the ages of 18 and 60 years old, and who have a condition called Posttraumatic Stress Disorder. Insomnia refers to difficulty falling or staying asleep, although enough time is allowed for sleeping. Insomnia is also associated with daytime consequences, such as lack of energy, irritability, and difficulty concentrating. Nightmares are bad dreams that may or may not awaken the sleeper, and that cause discomfort during the daytime. Chronic Posttraumatic Stress Disorder (PTSD) refers to symptoms that occur after someone experienced or witnessed a life-threatening event, and that persist for three months or more after the event. Symptoms include flashbacks, nightmares, feelings of detachment from others, sleep disturbances, irritability, anxiety, and efforts to avoid people and places associated with the life-threatening event. These symptoms occur after a life-threatening event. Symptoms that persist for more than one month indicate the presence of PTSD. In the present study, we will study people with chronic PTSD, which refers to PTSD symptoms that persist for more than 3 months. Efficacy of a treatment is defined as the capacity to produce the desired effects. In this study, we will evaluate and compare the capacity of two active experimental treatments to reduce insomnia and nightmares associated with PTSD, and one inactive intervention, called a placebo, for people who continue to have sleep difficulties despite receiving treatment with an antidepressant medication called a selective serotonin reuptake inhibitor (SSRI, like Prozac, Paxil, Zoloft, Celexa). The two active experimental treatments are a medication, prazosin, and a brief behavioral intervention, which involves exercises and techniques to reduce nightmares and improve sleep quality. Prazosin is an approved medication by the Food and Drug Administration (FDA) against high blood pressure, but is not FDA-approved for posttraumatic insomnia and nightmares.