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NCT ID: NCT01719315 Completed - Clinical trials for Major Depressive Disorder

Neurophysiologic Correlates of Hypersomnia

Start date: November 2012
Phase:
Study type: Observational

The goal of this project is to examine the neurophysiology of hypersomnia during sleep and wakefulness, to identify biomarkers for excessive sleepiness in neuropsychiatric disorders, and pilot acoustical slow wave induction during sleep in patients with hypersomnolence, to determine if this decreases daytime sleepiness in these patients. The primary study hypotheses are that individuals with hypersomnolence will have reduced slow wave activity (SWA) during sleep and increased waking theta/alpha activity during wake in specific brain regions. A secondary hypothesis is that acoustical slow wave induction in hypersomnolent patients will increase SWA during sleep, reduce theta/alpha activity during wake, and improve subjective sleepiness.

NCT ID: NCT01718730 Completed - Clinical trials for Depressive Disorder, Major

Cortical Excitability and Inhibition in MDD

Start date: October 2012
Phase:
Study type: Observational

The purpose of this study is to learn if measures of brain activity are different in children and adolescents with depression who are in different stages of treatment. This is important because it may identify a biological marker for depression that could one day be used to identify depressed children who would benefit from certain treatments (medications for example), or to monitor how well treatments are working. Brain activity measures(known as cortical excitability and inhibition) will be collected by Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive (no surgery or implants) brain stimulation technology which can make parts of the brain work without putting any wires or chemicals into the body. Measurements will take place over one 3-hour visit. This study does not provide any form of treatment. *There is an optional portion of the study that uses a brain scan to gather measures of brain structure and brain chemicals. The brain scan is called magnetic resonance and spectroscopy (MRI/MRS). MRI/MRS uses magnetic fields to study the structure of the brain and brain chemicals. The PI will determine eligibility for the MRI/MRS portion of the study.

NCT ID: NCT01718249 Completed - Clinical trials for Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)

Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness

Post-coma DBS
Start date: April 2012
Phase: N/A
Study type: Interventional

Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest that deep brain stimulation of the thalamic-tegmental reticular system could improve consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this protocol is to study the effects of deep brain stimulation on conscious behavior, using a patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised (CRS-R) as clinical assessment criterion.

NCT ID: NCT01715805 Completed - Clinical trials for Major Depressive Disorder

Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD)

Start date: November 15, 2012
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD

NCT ID: NCT01714050 Completed - Clinical trials for Seasonal Affective Disorder (SAD)

Cognitive-behavioral Therapy vs. Light Therapy for Preventing SAD Recurrence

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

Major depression is a highly prevalent, chronic, and debilitating mental health problem with significant social cost that poses a tremendous economic burden. Winter seasonal affective disorder (SAD) is a subtype of recurrent major depression involving substantial depressive symptoms that adversely affect the family and workplace for about 5 months of each year during most years, beginning in young adulthood. This clinical trial is relevant to this public health challenge in seeking to develop and test a time-limited (i.e., acute treatment completed in a discrete period vs. daily treatment every fall/winter indefinitely), palatable cognitive-behavioral treatment with effects that endure beyond the cessation of acute treatment to prevent the annual recurrence of depression in SAD. Aim (1) To compare the long-term efficacy of cognitive-behavioral therapy (CBT) and light therapy on depression recurrence status, symptom severity, and remission status during the next winter season (i.e., the next wholly new winter season after the initial winter of treatment completion), which we argue to be the most important time point for evaluating clinical outcomes following SAD intervention. Hypothesis: CBT will be associated with a smaller proportion of depression recurrences, less severe symptoms, and a higher proportion of remissions than light therapy in the next winter. The study is designed to detect a clinically important difference between CBT and light therapy in depressive episode recurrences during the next winter, the primary endpoint, in an intent-to-treat analysis. Aim (2) To compare the efficacy of CBT and light therapy on symptom severity and remission status at post-treatment (treatment endpoint). Hypothesis: CBT and light therapy will not differ significantly on post-treatment outcomes.

NCT ID: NCT01710202 Completed - Clinical trials for Major Depressive Disorder

Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration

5-HTTLPR
Start date: October 2012
Phase: N/A
Study type: Observational

The current study will test the causal relationship between elevated levels of cortisol and the serotonin transporter gene (5-HTTLPR) as these factors influence sensitivity to environmental threat. The investigators predict that carriers of the short allele of the serotonin transporter gene who have elevated cortisol levels will be most sensitive to threatening environments, whereas carriers of the long allele who do not have elevated cortisol (placebo subjects) will be least sensitive.

NCT ID: NCT01708681 Completed - Clinical trials for Glucose Metabolism Disorders

Lean Seafood Intake and Postprandial Metabolism

LeSIP
Start date: October 2012
Phase: N/A
Study type: Interventional

Despite numerous studies of meal components in humans, little is still known about how different meals influence on metabolism. The purpose of this study is to a gain knowledge of how a balanced test meal with either lean seafood (example:cod) or meat as the main protein source will: 1. affect the postprandial metabolism acutely (test-meal at beginning of the study) 2. affect the postprandial metabolism after 4 weeks controlled intervention (test meal at end of intervention period) 3. affect gut microbiota composition

NCT ID: NCT01708226 Completed - Clinical trials for Obsessive Compulsive Disorder

Attention Training for Childhood Obsessive Compulsive Disorder: An Open Case Series

AMPOCD
Start date: November 2012
Phase: Phase 1
Study type: Interventional

Pediatric Obsessive Compulsive Disorder (OCD) is a chronic, impairing condition that accrues significant concurrent and long-term risk to affected youth. Although empirically supported psychosocial and pharmacological treatments for OCD exist, many children and their families are not able to adequately access these treatments or derive only partial benefit from them. Such findings highlight the importance of developing more effective treatment options which have the potential to be widely accessible to OCD youth. The investigators are proposing to test a computerized attention modification program, AMP, in six youth with OCD in an open case series to gather information regarding protocol acceptability, feasibility and preliminary efficacy. This phase includes the development and refinement of stimuli selection procedures, behavior avoidance task, EEG protocol, and AMP parameters for use with children. Following ascertainment of study eligibility, participants will undergo a baseline assessment consisting of a clinical interview, neurocognitive assessments, EEG, attention bias assessment, and self report questionnaires. Study participants will then receive 12 sessions of AMP treatment over the course of three weeks. All youngsters and their families will be reassessed at treatment endpoint (week 4). Participation will take a total of about 24 hours over the course of six weeks. Participants who are treatment responders may be asked to return approximately 3 months after completing treatment for a follow-up assessment. Preliminary hypotheses: 1) AMP will be acceptable to youth and families and feasible to administer; 2) Youth receiving AMP will demonstrate decreases in threat bias and OCD symptom severity.

NCT ID: NCT01704352 Completed - Bipolar Disorder Clinical Trials

Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder

Start date: January 2013
Phase: N/A
Study type: Interventional

Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases. Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and insomnia.

NCT ID: NCT01702220 Completed - Clinical trials for Generalized Anxiety Disorder

Calmer Life: Testing the Effectiveness of a Treatment for Anxiety

Start date: October 2012
Phase: N/A
Study type: Interventional

The overall goals of the proposed research study are to: (1) examine quantitative outcomes in a well-conducted randomized clinical trial of Calmer Life, relative to Enhanced Community Care, an information and referral intervention that represents care in a real-world community-service environment, and (2) evaluate implementation feasibility, which includes training community providers; examining program reach, engagement, acceptability, and barriers-facilitators; and preparing practical tools for replicating the program.