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Anxiety Disorders clinical trials

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NCT ID: NCT00805493 Terminated - Bipolar Disorder Clinical Trials

Double-Blind Placebo-Controlled Trial of Riluzole in Pediatric Bipolar Disorder

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

Pediatric Bipolar Disorder (BD) is uncommon in children. Its symptoms include periods of manic behavior (being overly happy or giddy, feeling grandiose, feeling a decreased need for sleep, having too much energy, moving more than usual, talking fast, having speeded-up thoughts and other symptoms). Sometimes there also is depression (extreme feelings of sadness or irritability, not taking pleasure in things, even ones that used to be enjoyable, feeling worthless or guilty, sleeping too much or having trouble getting to or staying asleep, feeling slowed down or restless, having wishes to be dead or suicidal ideas, and other symptoms). Pediatric BD is often difficult to treat; children may respond only partially to the medications now available or have too many side effects to tolerate them. Riluzole is a medication that is thought to work on a brain chemical called glutamate that may be involved in symptoms of depression and BD. Previous research studies have shown that riluzole may help adults with BD who have depression and adults who have depression, anxiety disorders, or obsessive-compulsive disorders. Riluzole may also be helpful for children with obsessive-compulsive disorder. However, it has never been given to children with BD. This study will evaluate the effectiveness of riluzole in 80 patients between 9 and 17 years of age who have BD and symptoms of anxiety. Participants must have tried at least two other medications that have not been effective. The study will consist of four phases carried out over 4 to 5 months. Most children will be inpatients at the Pediatric Behavioral Health Unit for at least part of the study. In Phase 1, each patient will undergo blood and urine tests, and will gradually taper off his or her medication. The duration of this phase depends on the medication that the patient was receiving before starting the study. In Phase 2, the patient will remain off all medication for 1 week. Throughout this time, patients will be monitored carefully and medication will be restarted if needed. In Phase 3, which lasts 8 weeks, patients will be assigned randomly to receive only riluzole or only a placebo. Those who receive riluzole will have the dose adjusted as needed. Patients and families will be informed of which drug they were on at the end of this phase. Patients who improved on riluzole may continue to receive it from NIH for 1 month and will then be prepared for discharge from the study. Patients who received placebo and improved, and those who received riluzole but did not improve, will be treated with standard medications as appropriate and prepared for discharge from the study. Phase 4 is for patients who received placebo and did not improve. They will be given the chance to try riluzole for 8 weeks and, if it is effective, continue it for an additional 4 weeks while they prepare to be discharged from the study. Patients will not be able to receive riluzole at the National Institutes of Health after the completion of the study. However, the child's doctor may be able to prescribe riluzole as an off-label use. Most patients will be admitted to the Pediatric Behavioral Health Unit at the National Institutes of Health Clinical Center during the medication withdrawal part of the study (Phases 1 and 2). From Phase 3 on, a patient may participate as an inpatient, outpatient, or in day treatment, depending on what is in his or her best interests. All participants in this study will be invited to also enroll in the National Institute of Mental Health protocol 00-M-0198, The Phenomenology and Neurophysiology of Affective Dysregulation In Children And Adolescents With Bipolar Disorder. Some research tests for that protocol will be done during the medication-free period of this protocol.

NCT ID: NCT00804180 Withdrawn - Anxiety Clinical Trials

Group Therapy Intervention for Children and Adolescents With Injection-Related Anxiety and Their Caregivers

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

The specific aim of this project is to determine the impact of this group therapy intervention on improving adherence, coping, and functioning among children and adolescents with disease processes requiring injections who experience injection-related anxiety.Hypotheses include: 1. General psychosocial (quality of life) improvements from beginning to post-treatment as well as maintenance of these improvements 2-4 weeks following the termination of treatment for both youth and parents. 2. Reduced injection-related anxiety from baseline to post-treatment as well as maintenance of this improvement 2-4 weeks following the end of treatment for both youth and parents. 3. Reduced anxiety immediately following exposure to feared injection- related stimuli. 4. For participants experiencing poor adherence to medical treatment, improvement in adherence as reported by both parents and youth from baseline to post-treatment as well as maintenance of these improvements 2-4 weeks following the end of treatment.

NCT ID: NCT00803361 Completed - Clinical trials for Generalized Anxiety Disorder

Duloxetine for the Treatment of Generalized Anxiety Disorder

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

This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder

NCT ID: NCT00800280 Terminated - Clinical trials for Generalized Anxiety Disorder

Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body

Start date: January 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.

NCT ID: NCT00794456 Completed - Anxiety Disorder Clinical Trials

Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety

Start date: September 2009
Phase: Phase 3
Study type: Interventional

Phase III, multicentric, double blind, randomized study, controlled by Valeriana officinalis for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. on mild and moderate anxiety. The treatment period will last 6 weeks and be followed by a post treatment visit. Hamilton anxiety scale will be used to assess anxiety.

NCT ID: NCT00788034 Completed - Clinical trials for Generalized Anxiety Disorder

Relapse-prevention Study With Lu AA21004 (Vortioxetine) in Patients With Generalized Anxiety Disorder

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

The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.

NCT ID: NCT00787397 Completed - Clinical trials for Generalized Anxiety Disorder

Sleep, Mood, and Behavior Study

Start date: February 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to assess whether improving sleep in children and adolescents with anxiety disorder will further enhance affective, clinical, and social functioning.

NCT ID: NCT00781677 Completed - Depression Clinical Trials

Using Neuroimaging to Investigate Major Depressive Disorder

Start date: May 2008
Phase:
Study type: Observational

The purpose of this neuroimaging study is to investigate the brain correlates of Major Depressive Disorder with anxiety symptoms as well as potentially identify predictors of treatment outcome.

NCT ID: NCT00774150 Completed - Clinical trials for Generalized Anxiety Disorder

Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study

CATS
Start date: October 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate neurobehavioral, affective, and social processes that may influence and predict treatment response in pediatric anxiety disorders.

NCT ID: NCT00773162 Completed - Clinical trials for Social Anxiety Disorder

Flushing in Social Anxiety Disorder on Seroquel

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

To add to our understanding of the relationship between blushing, symptom severity and potential mechanisms that underlie blushing in patients with Social Phobia (SP), the investigators propose comparing SP patients' vascular responses to topical m-N pre and post treatment with Seroquel or placebo. Atypical antipsychotics such as seroquel have been used successfully as adjunctive treatments in other anxiety disorders, including PTSD (Labatte, 2001; Krashin & Oates, 1999; McDougle et al., 2000; Pfanner et al., 2000; Bogetto et al., 2000) and Generalized Anxiety Disorder (Katzman et al., 2005). Responses to the blushing exposure will be assessed prior to and following treatment with seroquel or placebo and at one month following intervention. Levels of prostaglandin will be compared between groups and will also be correlated with symptom severity in the clinical groups. The objective of this randomized, double blind flexible -dose study will be to evaluate the efficacy , safety and tolerability of seroquel SR 50mg to 800mg and placebo in outpatient subjects diagnosed with SP. The study will begin with a single week of Seroquel 50mg or placebo. Subsequently, tablets will be administered by the investigator in a flexible dose fashion during the visits. Patients will be followed up weekly (biweekly after week 6) and at the clinician's discretion. After the fist week the patients' dosage will be increased up to a maximum of 800 mg daily with expected average dose of 300mg dail. This dose will remain fixed after 8 weeks of treatment until week 16.