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NCT ID: NCT02414503 Completed - Clinical trials for Autism Spectrum Disorder

Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Adults With Autism Spectrum Disorder

Start date: April 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate lactation in breastfeeding women. The intranasal administration of OT has recently attracted attention as a potential novel treatment in several psychiatric disorders in autism. However, given the anatomy of the nasal cavity, the current design of nasal sprays would be expected to provide an inadequate delivery of medication to the areas of the nasal cavity where direct transport into the brain via the olfactory nerve could potentially occur. OptiNose has developed an intranasal delivery device that provides improved reproducibility of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity where the olfactory nerve innervates the nasal cavity. The primary objective of this study is to identify any differences between a single dose of 8 international units (IU) oxytocin, 24 IU oxytocin, and placebo delivered intranasally with the optimised OptiNose device in volunteers with Autism Spectrum Disorder. This will be measured in terms of performance on cognitive tests and physiological markers.

NCT ID: NCT02413918 Completed - Bipolar Disorder Clinical Trials

Iloperidone in Mixed States of Bipolar Disorder

Start date: April 2012
Phase: Phase 4
Study type: Interventional

1. To assess the acute and long-term bimodal efficacy of iloperidone (IL), as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD. 2. To assess background, baseline features, and behavioral components which characterize treatment response/non-response in the acute and long term management of MS

NCT ID: NCT02413905 Completed - Malnutrition Clinical Trials

Characterizing the Gut Microbiota Alteration Associated With Severe Acute Malnutrition

Start date: January 2014
Phase: N/A
Study type: Observational

The investigators performed two case-control studies in Niger and Senegal analysing fecal microbiota to characterize the specificity of the gut microbiota alteration associated with severe acute malnutrition (SAM).

NCT ID: NCT02413216 Completed - Tourette's Disorder Clinical Trials

TicHelper: A Computerized Comprehensive Behavioral Intervention for Tics (CBIT)

Start date: August 2015
Phase: N/A
Study type: Interventional

Tic Disorders (including Tourette Disorder) are relatively common in school-age children and for some children can lead to significant psychosocial and physical impairment and diminished quality of life. Non-pharmacological treatments have been shown to be effective for reducing tics in some children. These treatment options are desired by parents, but are not widely available. The investigators recently developed an online, computerized, self-administered version of CBIT called TicHelper.com. The current study will test the efficacy of TicHelper.com in a randomized clinical trial.

NCT ID: NCT02409823 Completed - Schizophrenia Clinical Trials

Clinical Registry of Patients Under Treatment With Atypical Antipsychotics

Start date: February 2015
Phase: N/A
Study type: Observational

Antipsychotic drugs are characterized by blocking dopaminergic D2 receptors. They have been found to be effective and safe for the treatment of schizophrenia, bipolar disorders, depressive episodes associated with bipolar disorder, or psychotic symptoms in the context of Parkinson's disease. Atypical antipsychotics have lower blocking potency on D2 receptors, at the time that interact with serotoninergic, adrenergic and histaminergic receptors, among others. Quetiapine extended-release has the same clinical efficacy as the immediate-release formulation, but reduces the amount of daily doses, possibly contributing to increased treatment adherence. The purpose of this registry is to explore adherence to treatment, the occurrence of adverse drug reactions and the clinical outcomes in a sample of patients under treatment with atypical antipsychotics in several Central American countries. For this study, clinical data will be extracted from the medical records of 1000 patients with schizophrenia, depressive disorders or Parkinson's Disease with hallucinations. Occurrence of adverse drug reactions, namely weight gain, somnolence, extrapyramidal reactions and symptoms of orthostatic hypotension; adherence to treatment; and changes in quality of life and clinical status will be assessed during the first 8 weeks of treatment.

NCT ID: NCT02407704 Completed - Depression Clinical Trials

A Multi-level Life-span Characterization of Adult-depression and Effects of Medication and Exercise

MEDEX
Start date: March 2015
Phase: Phase 4
Study type: Interventional

This pilot study aims to test a model that predicts that enhanced neurotransmitter gamma-aminobutyric acid (GABA) function in reward and affect-regulation central nervous system (CNS) circuits mediates the antidepressant effects of exercise. State-of-the-art magnetic resonance (MR) imaging, cognitive assessment, accelerometry, genetic, and inflammatory biomarkers will be acquired through the coordination of efforts from several established research programs at Western Psychiatric Institute and Clinic. This pilot study will be used as a platform for testing a causal/mediating role of GABA interneurons in reward processing and affect regulation in humans. This pilot study is not powered for testing a full causal model, but rather is intended to test overall feasibility of the intervention and acquisition of measures (see specific aim 1 below). This is a necessary prerequisite for designing a larger more definitive study of the model, which will be a component of a future grant application. Additionally, the data from this study will be used to test the clinical efficacy of exercise as an adjunctive treatment for late life depression (LLD; Specific Aim 2), as well as imaging, cognitive, and sleep aims (Specific Aims 3 and 4).

NCT ID: NCT02407340 Completed - Alcoholism Clinical Trials

Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder

Start date: March 2015
Phase: Phase 1
Study type: Interventional

This study will examine the utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of Alcohol use disorder (AUD). Non-treatment seeking men and women with AUD will be enrolled in a double blind placebo controlled phase I clinical trial. Participants will complete an 7-day inpatient protocol. During the first 3 days of the inpatient protocol, participants will complete alcohol abstinence in which withdrawal symptoms are measured,and urine will be collected to determine withdrawal symptom severity and urine levels of the stress hormone cortisol. Participants will then complete 3 laboratory procedures which measure 1) stress response, 2) motivation to drink alcohol and 3) subjective and physiological effects of alcohol. Finally, because participants are individuals with AUD, investigators will administer a brief intervention to address their risky alcohol drinking and problems before discharge.

NCT ID: NCT02406066 Completed - Clinical trials for Tobacco Use Disorder

Single and Multiple Rising Dose Study of Safety and PK of Metyrapone/Oxazepam Combination (EMB-001)

Start date: March 2015
Phase: Phase 1
Study type: Interventional

This is a study of EMB-001 (a combination of two FDA-approved drugs, metyrapone and oxazepam) in otherwise healthy adults who are regular cigarette smokers. There will be 3 groups of 8 subjects; in each group, 6 subjects will get the drug combination and 2 will get placebo. Neither the subjects nor the study personnel will know who got drug and who got placebo (double-blind). In the first group the drug doses will be low, and they will be increased in the second and third groups. Subjects will receive a single dose on Day 1, followed 24 hours later by the start of doses twice daily for 7 days, and then a final morning dose on the last day. The levels of the drugs in the blood will be assessed by repeated blood draws after the first day and after the end of dosing. Safety will be assessed after the single dose and repeated dosing. Effects of study drug on smoking and craving cigarettes will be assessed at the end of repeated dosing. The hypothesis is that this drug combination will be safe, with relatively few side effects.

NCT ID: NCT02405117 Completed - Bipolar Disorder Clinical Trials

A Mobile Behavioral Monitoring Intervention for Bipolar Disorder

Start date: January 10, 2014
Phase: N/A
Study type: Interventional

This study will develop and pilot a smartphone intervention, LiveWell, to enhance patient self-management of bipolar disorder and facilitate more efficient, timely care delivery by mental health providers. The intervention uses a mobile application to collect daily self-report and continuous behavioral data and adapts intervention content to create a highly tailored and user-responsive treatment system. Patient data collected by the phone will also be provided to clinicians to allow for better evaluation and targeting of treatment. The goal is to reduce symptoms and prevent relapse in patients with bipolar disorder.

NCT ID: NCT02404246 Completed - Bipolar Disorder Clinical Trials

Pilot Trial of Peer Support for Bipolar Disorder

Start date: December 2005
Phase: N/A
Study type: Interventional

This pilot effectiveness trial will evaluate the feasibility, acceptability, and effectiveness of a structured peer support program based on the Certified Peer Specialist Program of the Depression and Bipolar Support Alliance (DBSA).