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Bipolar Disorder clinical trials

View clinical trials related to Bipolar Disorder.

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NCT ID: NCT02560701 Completed - Bipolar Disorder Clinical Trials

High Deductible Health Plans and Bipolar Disorder

Start date: September 2015
Phase:
Study type: Observational

Using eleven years (2004-2014) of claims data from the largest US commercial health insurer, the investigators will assess the impact of switching into high-deductible health plans (HDHPs) on outcomes for patients with bipolar disorder. Patient subgroups will include patients with and without high medication cost-sharing and vulnerable populations (racial/ethnic minorities, poor, rural, major comorbidities). Interviews with patients and caregivers recruited through a major advocacy group will provide further insights into the policy issues with real-life experiences.

NCT ID: NCT02558075 Completed - Depression Clinical Trials

Mood Lifters: A Self Help Program

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Large scale, effective, low-cost, and evidence-based programs that can nimbly translate new research discoveries into prevention and care for psychosocial based problems are urgently needed. This study hopes to provide support for Mood-Lifters, a template for a low-cost evidence based program, so that investigators may fill this gap and relieve suffering for millions of people who are not getting adequate mental health care. Mood-Lifters provides a low cost, research based program designed to enrich people's lives and reduce psychological distress. It is designed to provide useful support, coaching and information. It seeks to help people enhance pleasure, engagement and meaning in their lives while minimizing depression, fear, loneliness and other negative feelings via a proprietary peer based program that offers weekly meetings and other flexible support options. The goal of this pilot study is to test the efficacy of this program. This is not traditional therapy, rather an educational supportive program similar to WeightWatchers, but for mental health.

NCT ID: NCT02553161 Completed - Depression Clinical Trials

Mechanism of Antidepressant-Related Dysfunctional Arousal in High-Risk Youth

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

A 16-week double blind, placebo-controlled investigation of escitalopram in adolescents with depression and/or anxiety with a family history of Bipolar Disorder. Subjects will be evaluated using semi-structured diagnostic interviews and symptom ratings, participate in a MRI scan and then randomized to treatment. Following randomization, high-risk youth will have visits every week for the first 4 weeks of treatment then biweekly up to 16 weeks during which time tolerability and ratings will be performed. MRI scan will be repeated at week 4.

NCT ID: NCT02527564 Completed - Bipolar Disorder Clinical Trials

Efficacy of Suvorexant to Treat Insomnia Related to Bipolar Disorder

Start date: September 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy of suvorexant, added to existing medications, for treatment-resistant insomnia in individuals with bipolar disorder. The investigators hypothesize that participants receiving suvorexant for one week will experience significantly greater improvement in sleep duration compared to participants receiving placebo.

NCT ID: NCT02520024 Completed - Schizophrenia Clinical Trials

Assessing the Impact of Self-directed Care, Within a Medicaid-funded Environment,on Participation and Community Living

Start date: January 2010
Phase: N/A
Study type: Interventional

This project proposed to demonstrate the effectiveness, costs, and benefits to participation and community living self-directed care programming within a financially sustainable Medicaid managed care environment. The study examined outcomes associated with the implementation of a novel self-directed care (SDC) approach being implemented in Delaware County, Pennsylvania in which consumers were able to access a set amount of renewable funds per year and direct how they were spent, both to purchase the types and amounts of rehabilitation and treatment services they desire (and from whom they choose) and to purchase a broad-range of individualized resources and services that are generally outside of Medicaid funding (e.g., health club memberships, yoga classes, support in taking care of bills).

NCT ID: NCT02519543 Completed - Bipolar Disorder Clinical Trials

Treating Insulin Resistance as a Strategy to Improve Outcome in Refractory Bipolar Disorder

TRIO-BD
Start date: September 2015
Phase: Phase 3
Study type: Interventional

In a previous study by Dr. Calkin, the principal investigator of this study, persons with bipolar disorder and either type II diabetes or insulin resistance were found to experience more severe symptoms of bipolar illness and a lower response to treatment, compared to persons with bipolar disorder who did not have type II diabetes or insulin resistance. To further explore these findings, the investigators have developed this study to see if treating insulin resistance (using metformin, a drug used to improve the body's use of insulin) may also help improve the symptoms of bipolar illness.

NCT ID: NCT02515773 Completed - Bipolar Disorder Clinical Trials

Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs

MOBILITY
Start date: December 2015
Phase: Phase 4
Study type: Interventional

A prospective, large, pragmatic, randomized trial to study the impact of METFORMIN and healthy lifestyle intervention (LIFE) vs. LIFE alone on patient-centered outcomes of body weight, SGA-adherence and satisfaction, psychiatric symptom burden (e.g. mood/anxiety), and Quality of Life.

NCT ID: NCT02513654 Completed - Bipolar Disorder Clinical Trials

Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects

Start date: September 6, 2015
Phase: Phase 1
Study type: Interventional

This Pharmacokinetic (PK) study is going to provide supplemental PK data for supporting bipolar Phase III study for New Drug Application (NDA) filing according to regulatory requirement. The primary objective of this study is to evaluate the PK of lamotrigine following repeat dosing of lamotrigine dispersible tablet in healthy Chinese subjects. This study consisted of Screening Phase (Days-14 to 0), Open-label Phase (Days 1 to 51) and follow-up Phase (10-17 days after last dosing). After signing the informed consent and confirm the eligibility, subjects will start dosing with lamotrigine 25 mg dispersible tablet once daily at Day 1 and remain at this dose level for two weeks (Days 1-14), then will be titrated to 50 mg once daily at Day 15 and last for weeks 3-4 (Days 15-28), and then titrated to 100 mg once daily at Day 29 during weeks 5-6 (Days 29-42). The total duration of the study will be approximately 10 weeks including screening and follow-up phase.

NCT ID: NCT02507349 Completed - Schizophrenia Clinical Trials

Person-Centered Versus Measurement-Based Care in Mental Health

PCORI-SDM
Start date: August 2014
Phase: N/A
Study type: Interventional

Fifteen minutes is the typical length of an outpatient medication management appointment for people with serious mental health conditions. These brief interactions with prescribers are frequently provider-driven with insufficient time focused on the patient's needs and personal recovery. Shared decision making is a strategy that could improve this interaction. This study examines how technology can be used in the care process to amplify the voice of the patient, support shared decisions, and improve treatment outcomes. Investigators will compare the effectiveness of Measurement-Based vs. Person-Centered Care on two primary patient-centered outcomes: the patient experience of care with medication treatment and the level of shared decision making. Investigators hypothesize that: 1. Person-Centered Care will result in greater improvement in patient experience of care with medication treatment than Measurement-Based Care. 2. Person-Centered Care will result in a greater level of shared decision making during the medication visit than Measurement-Based Care. The study team will collect information from patients, caregivers, and clinic staff at different points in time during the study. Patients will be asked to complete questionnaires, and additional data on their service use will be gathered. Some patients and providers will also be interviewed about their experiences with care. Investigators are especially interested to learn if and how these two approaches are perceived to change medication treatment, if patients are more satisfied and empowered in their care, and why and how providers perceive and adopt changes to their clinical care.

NCT ID: NCT02506322 Completed - Bipolar Disorder Clinical Trials

Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder

A2BipoLife
Start date: August 1, 2015
Phase: N/A
Study type: Interventional

This efficacy study compares an adjuvant specific psychotherapy and an active control intervention for Bipolar Disorder under mood stabilizer to prevent relapse an maintain remission. Patients should be in their early (18-30 yr.) phase of illness without having suffered of to many affective episodes (below 6), already. In addition, psychological, social, and neurobiological mediators and moderators well be identified.