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Post-Traumatic Stress Disorder
Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
Posting Date: 12/27/2005
Study Contact: 1-866-44-WORRY or send email to anxietystudy@partners.org
Description: This is an 8-week research study in which subjects will receive both eszopiclone and placebo (a pill that contains no medicine) at different points in the study. The purpose of the study is to find out if eszopiclone (Lunesta) is safe and effective for people with post-traumatic stress disorder (PTSD)-related sleep disturbance. Subjects will receive either eszopiclone or placebo for 3 weeks. After the 3- week period, subjects will not take any study medication (a washout period to let the study medication leave the body) for 1 week. They will then take the other study medication that they did not receive during the first 3-week period. For example, if they received eszopiclone during the first 3-week period, they will take placebo during the second 3-week period. The last 3-week period will be followed by another 1-week washout period.
Inclusion Criteria: Subjects will be male or female outpatients, ages 18-64, with a diagnosis of post-traumatic stress disorder. Pregnant or lactating women or those able to become pregnant not using medically accepted forms of birth control cannot take part in the research study. Participants may not have a history of seizures. In addition, subjects with severe and/or uncontrolled medical problems as well as those who are taking psychiatric medications, other than a stable dose of antidepressants, are excluded.
Understanding Cue Learning in Patients with Mood and Anxiety Disorders
Posting Date: 05/24/2006
Study Contact:1-866-44-WORRY or send email to anxietystudy@partners.org
Description: Healthy men and women ages 18-64 who are currently either not taking any psychiatric medications or are on a stable dose of medication and have a current diagnosis of Panic Disorder, Post-Traumatic Stress Disorder, or Major Depression, or a past diagnosis of Panic Disorder or Post-Traumatic Stress Disorder are needed for a research study to learn how differences in learning under mildly-stressful circumstances may be related to the presence of mood and anxiety disorders. Subjects will come to the hospital on two consecutive days for about 2 hours each day. Participation involves having a psychiatric interview, as well as having your heart rate, muscle activity and the moisture on your skin measured while you watch a series of colored shapes on a computer monitor. Some of the colored shapes may be followed by an annoying but not painful electrical stimulus. Procedures will take a total of three to four hours and participants will be paid up to $80 for their time and effort.
Social Anxiety Disorder
Improving Outcomes in Pharmacotherapy of Social Phobia
Posting Date: 4/1/2008
Study Contact: call 1-866-44-WORRY or send email to anxietystudy@partners.org
Description: This study will compare the usefulness of three different medication strategies for treating individuals with social anxiety disorder who have not responded well to an established treatment (i.e., the medication sertraline, also known as ZoloftÒ). Each of these 3 medication strategies involve taking a medication that is currently marketed for anxiety and approved by the U.S. Food and Drug Administration (FDA) for sale for the treatment of anxiety. The study is a two phase, 23-week research study in which subjects who remain symptomatic at the end of one phase enter into the next. In Phase I, all subjects receive sertraline (ZoloftÒ) for 10 weeks. Subjects who remain symptomatic will enter Phase II, in which subjects will be randomly assigned (there will be a one-in-three chance of being assigned to each group) to either keep taking sertraline, switch to taking sertraline and clonazepam, or switch to taking only venlafaxine extended-release for the remaining 12 weeks of the study. At the end of the study, you will enter follow-up care with the study doctor.
Inclusion Criteria: Patients age 18 or older with a primary diagnosis of generalized social anxiety disorder. Patients with a history of schizophrenia, psychotic disorders, bipolar disorder, mental disorder due to a medical condition or substance, obsessive-compulsive disorder, or post-traumatic stress disorder are excluded. In addition, patients with severe and/or uncontrolled medical problems, and patients taking other psychotrophic medications are excluded.
D-Cycloserine Enhancement of Exposure in Social Phobia
Posting Date: 2/18/2008
Study Contact: call 1-866-44-WORRY or send email to anxietystudy@partners.org
Description: This study will provide individuals who meet criteria for Social Phobia with 12 weekly sessions of Cognitive Behavioral Therapy lasting approximately two and a half hours each. During these sessions, patients will receive information on the nature of social phobia and a model of treatment and will receive weekly training in how to become more comfortable with social situations, with the goal of achieving confidence in social interactions. As part of this training, the therapist will practice social interactions with the patient, who will also be asked to practice what they have learned outside of the therapists’ office. For the third, fourth, fifth, sixth, and seventh sessions of the twelve-session program of Cognitive Behavioral Therapy, the patient will be asked to arrive one hour early to take one of the study pill, a 50mg pill of either d-cycloserine or placebo, which participants will be randomly assigned to. A physician will be available in the unlikely event that a patient begins to experience side effects. Before the treatment starts, before the eighth session, and one week after the final session patients will have their levels of symptoms assessed with measures of mood, anxiety, and avoidance. Upon completion of the study, participants will be asked to return for a one-month, three-month, and six month-followup.
Eligibility Criteria: Male or female outpatients 18 years or older with a primary diagnosis of generalized social anxiety disorder (as determined by the psychiatrists who conduct our initial screening process); physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities; willingness and ability to comply with the requirements of the study protocol; participants currently taking psychotropic medication will be excluded.
Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome
Posting Date: 08/26/2005
Study Contact: call 1-866-44-WORRY or send email to anxietystudy@partners.org
Description: This is a two phase, 24-week research study in which participants who remain symptomatic at the end of one phase (6 weeks) enter into the next phase. In Phase I, all participants receive duloxetine (Cymbalta) for 6 weeks. Participants who continue to have anxiety symptoms will enter the 18-week Phase II, in which they continue taking Cymbalta and they will also be randomly assigned (by chance, like a flip of a coin) to receive either an increased dose of Cymbalta or placebo (contains no active medication).
Inclusion Criteria: People who are over the age of 18, who are experiencing symptoms of Social Anxiety Disorder, and who are not currently taking another psychiatric medication may be eligible for this study. Women who are pregnant or breastfeeding or who are not on an approved form of contraception will not be eligible. People with a history of bipolar disorder, schizophrenia, or other psychotic conditions are excluded. People with severe and/or uncontrolled medical problems or glaucoma are excluded.
Complicated Grief
Escitalopram for the Treatment of Complicated Grief: A Pilot Study
Posting Date: 03/09/2005
Study Contact: contact Richard at 617-726-4585
Description: This is a 10 week research study in which all patients will receive escitalopram (Lexapro). The purpose of the research study is to examine how treatment with escitalopram may affect symptoms related to complicated grief and stress related chemicals in the body.
Inclusion Criteria: Patients ages 18-75 years who are experiencing persistent grief at least 6 months after the death of a loved one. Patients with a history of bipolar disorder, schizophrenia, or other psychotic condition are excluded. Patients with severe and/or uncontrolled medical problems are excluded. Patients currently receiving psychotherapy directed towards the treatment of complicated grief are also excluded.
Note: this study is not currently enrolling new patients.
Panic Disorder
Duloxetine for Panic Disorder
Posting Date: 07/12/2006
Study Contact:1-866-44-WORRY or send email to anxietystudy@partners.org
Description: This is a 10 week research study in which all subjects will receive duloxetine (Cymbalta).The purpose of the research study is to examine how treatment with duloxetine may affect symptoms related to Panic Disorder.
Inclusion Criteria: People who are between the ages of 18 and 65, who are experiencing symptoms of Panic Disorder and who are not currently taking another psychiatric medication may be eligible for this study. Women who are pregnant or breastfeeding or who are not on an approved form of contraception will not be eligible. People with a history of bipolar disorder, schizophrenia, or other psychotic conditions are excluded. People with severe and/or uncontrolled medical problems or acute narrow-angle glaucoma are excluded. People currently receiving psychotherapy directed towards the treatment of anxiety are also ineligible to participate.
Understanding Cue Learning in Patients with Mood and Anxiety Disorders
Posting Date: 05/24/2006
Study Contact:1-866-44-WORRY or send email to anxietystudy@partners.org
Description: Healthy men and women ages 18-64 who are currently either not taking any psychiatric medications or are on a stable dose of medication and have a current diagnosis of Panic Disorder, Post-Traumatic Stress Disorder, or Major Depression, or a past diagnosis of Panic Disorder or Post-Traumatic Stress Disorder are needed for a research study to learn how differences in learning under mildly-stressful circumstances may be related to the presence of mood and anxiety disorders. Subjects will come to the hospital on two consecutive days for about 2 hours each day. Participation involves having a psychiatric interview, as well as having your heart rate, muscle activity and the moisture on your skin measured while you watch a series of colored shapes on a computer monitor. Some of the colored shapes may be followed by an annoying but not painful electrical stimulus. Procedures will take a total of three to four hours and participants will be paid up to $80 for their time and effort.
Generalized Anxiety Disorder
A Double-Blind, Randomized, Placebo-Controlled, Multi-center Study Examining the Efficacy and Safety of SEP-225441 in Subjects with Generalized Anxiety Disorder
Posting Date: 4/1/2008
Study Contact: call 1-866-44-WORRY or send email to anxietystudy@partners.org
Description: This is an 8-week research study in which participants will be randomly assigned (by chance, like a flip of a coin) to receive one of two doses of eszopiclone (SEP-225441, another form of Lunesta®) or placebo (contains no active medication).
Inclusion Criteria: Male or female non-smokers who are 18 to 50 years of age and who are experiencing symptoms of Generalized Anxiety Disorder may be eligible for this study. Women who are pregnant or breastfeeding or who are not using an approved form of contraception will not be eligible. Subjects with a history of bipolar or other psychotic condition are excluded. In addition, subjects with severe and/or uncontrolled medical problems as well as those who are taking psychiatric medications are excluded.
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