Active clinical trials for "Bipolar Disorder"

The aim of this study is to investigate the effect of repetitive TMS in reduction of depressive symptoms in patients with bipolar disorder. In a randomized, single blind clinical trials, 30 patients with bipolar disorder in Atieh Neuroscience center will be assigned to receive bilateral TMS and unilateral TMS, daily; for 20 sessions. The depressive and anxiety symptoms and quality of life will be assessed before the treatment (pre test) during the treatment (10th session), and after the treatment (post test). QEEG apply before and after rTMS in all subjects.

Transcranial electrical stimulation (TES) techniques offer a novel treatment approach for depression and have shown promising efficacy. However, there is no published data to date on their effectiveness as a maintenance treatment. This study will investigate ways of using TES as a maintenance treatment to prevent relapse in depression.

The purpose of this study is to whether vitamin d supplementation in those with low levels may reduce depression symptoms in people experiencing bipolar depression.

Bipolar disorder (BD) is a serious and chronic mental illness that is associated with substantial impairment in quality of life and functional outcomes, high rates of suicide, and high financial costs. In spite of a proliferation of treatments for BD, nearly half of individuals with BD do not benefit from pharmacotherapy because of sub-optimal medication treatment adherence. Non-adherence with BD medication treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD are multi-dimensional, and it has been suggested that adherence enhancement might work best if the intervention specifically addresses factors that are important and modifiable for a specific individual. In spite of the enormity of the problem, the literature on interventions to improve treatment adherence is surprisingly limited. There is an urgent need for interventions to enhance treatment adherence among BD patients that: 1) are at high risk for future treatment non-adherence; 2) may not have access to or interest in long-term, high-intensity, and specialized care; and 3) are flexible and patient-focused taking into account reasons for non-adherence for a specific individual. The proposed study is a first-ever RCT focused specifically on BD treatment adherence enhancement, and will test whether a customized adherence enhancement (CAE) psychosocial intervention improves adherence and mental health outcomes compared to broadly-directed, non-individualized education (EDU). The proposed project has the potential to greatly advance the care of BD patients who are at greatest risk for poor health outcomes, with findings expected to be generalizable across a variety of treatment settings. Hypothesis 1: CAE will be associated with greater improvement in treatment adherence compared to broadly-directed, non-individualized BD education (EDU). Hypothesis 2: CAE will be associated with improved BD symptoms compared to EDU.

The purpose of this pilot study is whether Eye Movement Desensitization Reprocessing (EMDR), an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning, quality of life, cognition and BDNF levels in subsyndromal bipolar patients with trauma.

This registration study in China is a multi-centre, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of lamotrigine in the prevention of recurrence/relapse of mood episodes in subjects with bipolar I disorder. Subjects are bipolar I disorder patients with recent/current manic, hypomanic, mixed or depressive episode. The study will include an open-label phase and a randomized phase. During the open-label phase, subjects will have lamotrigine monotherapy or combination therapy escalation. The target dose of lamotrigine is 200 milligram (mg)/day monotherapy. The duration of treatment in the open-label phase will last 6-16 weeks, until subjects reach a stable dose of lamotrigine. Beginning at week 7 of the open-label phase, subjects who have reached a stable dose of lamotrigine and met response criteria, defined as maintaining a Clinical Global Impression of Severity (CGI-S) score <= 3 for at least 4 continuous weeks and maintaining lamotrigine 200 mg/day monotherapy for at least 1 week, will be eligible to enroll in the double-blind phase of the study. Subjects who have not met response criteria after 16 weeks of participation in the open-label phase will be withdrawn from the study. Subjects will have lamotrigine 200 mg/day monotherapy for at least 1 week prior to randomization. Subjects who have met randomization requirements will be randomized 1:1 to lamotrigine 200 mg/day or placebo for 36 weeks double-blind treatment. After randomization, subjects will be assessed at weekly intervals for the first month, biweekly intervals for the second month, and then at monthly intervals for up to 36 weeks of double-blind treatment. The primary endpoint will be TIME, defined as the time to intervention (addition of pharmacotherapy or electroconvulsive therapy [ECT]) for any mood episode (relapse or recurrence of a depressive, manic, hypomanic or mixed episode) after randomization. The secondary endpoints will include time to intervention for manic, hypomanic or mixed episode (TIMan) and time to intervention for depressive episode (TIDep).The scores on the Hamilton Depression (HAMD), Young Mania Rating Scale (YMRS), CGI-I, CGI-S and Global Assessment Scale (GAS) will be used as indicators for both intensity and duration of mood symptoms during this phase. Subjects who withdraw early from the study prior to week 36 or reach TIME will have a follow-up visit 14 days after the last dose of investigational drug.

Inositol hexaphosphate (IP6, also called inositol hexakisphosphate, and phytic acid) is a naturally occurring phosphorylated derivative of myo-inositol. Myo-inositol has shown preliminary evidence of efficacy in controlling mood symptoms, and good tolerability in bipolar disorder in some studies, but failed to establish efficacy in subsequent meta-analyses. In the investigators proposed work, the investigators plan to orally administer the calcium/magnesium salt of IP6 (2,000-3,000 mg daily in two divided doses) to paid research subjects with a diagnosis of bipolar disorder who are in a depressed state, and who have failed an adequate course of treatment with lithium monotherapy. The investigators hypothesis is that IP6 may be similar to myo-inositol in terms of relieving depression, but more potent and effective. Our aim is conduct a preliminary pilot study in 30 subjects (15 treated with IP6, 15 treated with lamotrigine, an active comparator) to assess the efficacy and tolerability of IP6 as an adjunctive treatment to lithium, the mood stabilizer most commonly used to treat bipolar disorder.

This three-year intervention development proposal is submitted to the NIMH DATR Mood Disorders/Sleep Disorders Program A2-AID and is led by a New Investigator. The goal of this study is to further develop and then evaluate the clinical utility of a new personalized smart-phone intervention to enhance illness self-management in people with bipolar disorder. Bipolar disorder is a heterogeneous fluctuating condition and a leading source of disability. Consistent with NIMH Strategic Aim 3.2, self-monitoring tools are vital to clinical management and evidence-based psychosocial interventions for bipolar disorder. Practice guidelines state that all patients should receive education in self-monitoring and identifying adaptive responses to early warning signs and symptoms. Advances in technology have enabled electronic monitoring of patient-reported outcomes using mobile devices - an assessment strategy called Ecological Momentary Assessment (EMA). Using freely available software, we have developed a preliminary version of a novel smart-phone intervention that integrates EMA with brief psychosocial intervention designed for people with bipolar disorder. Mobile real-time interventions have been successfully applied in other chronic illnesses and have theoretical advantages over clinic-based interventions in motivating and cuing health-protective behavior. Our new intervention is called Personalized Real-Time Intervention for Stabilizing Mood (PRISM), and it delivers tailored intervention content naturalistically at the moment that symptoms occur. We recently conducted a small proof-of-concept study of PRISM in outpatient adults with bipolar disorder that suggests the intervention is feasible, presents no technological or operational barriers, yields data that corresponds with clinical ratings, and is perceived as useful by participants. Building from our preliminary work, we propose to further develop the intervention based on participant feedback and theoretically-driven enhancements. We will then conduct a randomized trial to assess the clinical utility of this new intervention over 12 weeks. Specifically, we will randomize a sample of 90 adults aged 18 and older with Bipolar Disorder I or II to one of two experimental conditions. Participants in both conditions will participate in two in-person sessions adapted from an evidence-based psychosocial intervention for bipolar disorder, aimed at identifying early warning signs and adaptive responses to symptom fluctuations. The Control condition will participate in the in-person sessions, and the PRISM condition will also utilize the smart phone device for 12 weeks. In this pilot trial, we will compare outcomes between the two conditions on standard clinical ratings of depressive and manic symptoms, along with psychosocial functioning. We will assess predictors of compliance and changes in outcomes in the PRISM condition to inform a larger effectiveness trial. We will use exploratory analyses to further refine the intervention, including capitalizing on the rich repeated measures obtained by the device. This study will provide a strong basis for a larger effectiveness trial, along with a potentially useful tool to enhance self-management in bipolar disorder. PUBLIC HEALTH RELEVANCE: Bipolar disorder is a leading cause of disability, and many people do not have access to evidence-based psychosocial interventions. Mobile devices may prove more effective than clinic-based interventions, because they deliver self-management strategies at the moment that symptoms occur. To lead to a larger effectiveness study, we propose to further develop our novel intervention uses mobile technology to monitor and intervene with symptoms in real-time, and then conduct a 12-week randomized trial in 90 patients to evaluate the acceptability and short-term efficacy of our smart-phone based intervention for bipolar disorder.

In period I, the treatment effect of FK949E was compared with that of placebo in a blind manner in bipolar disorder patients with major depressive episodes. In period II, the long-term safety and efficacy of FK949E was evaluated.

The purpose of this study is to assess the efficacy of oral glycine as an augmentation strategy in two psychotic patients with a triplication (4 copies) of the gene glycine decarboxylase (GLDC). Subjects will first undergo a double-blind placebo-controlled clinical trial in which one 6-week arm will involve glycine (maximum daily dose of 0.8 g/kg, administered on a TID dosing schedule) and one 6-week arm will involve placebo. A 2-week period of no treatment will occur between treatment arms. A 6-week period of open-label glycine (maximum daily dose of 0.8 g/kg, administered on a TID dosing schedule) will follow the double-blind placebo-controlled clinical trial. Prior to the double-blind placebo-controlled clinical trial and at the end of the open-label glycine trial, the following procedures will be carried out: structural MRI (3T), Proton 1H MRS (4T), fMRI (3T), steady-state visual evoked potentials, and EEG. Positive, negative, and affective symptoms and neurocognitive function as well as plasma levels of large neutral and large and small neutral and excitatory amino acids and psychotropic drug levels will be assessed periodically. In addition, 1H MRS (4T) for 2 hours after a single oral dose of a glycine-containing drink will be assessed at baseline. Pharmaceutical grade glycine powder (Ajinomoto) or placebo will be dissolved in 20% solution and prepared by the McLean Hospital Pharmacy. Because the results of the double-blind placebo-controlled and open-label glycine treatment arms showed substantial clinical benefit to the participants, the study has been extended to include six months of chronic open-label glycine in order to determine 1) whether the clinical benefits achieved within 6 weeks previously recur, 2) the clinical benefits are lasting, and 3) additional clinical benefits occur with longer exposure. The glycine for this extension will be provided by Letco Medical. The investigators hypothesize that mutation carriers will have reduced endogenous brain glycine and GABA levels and increased brain glutamate and glutamine levels. Glycine administration will increase brain glycine in the two carriers, but to a lesser extent than in non-carrier family members and controls. The investigators hypothesize reduced activation of magnocellular pathways and abnormal ERPs modulated by NMDA in mutation carriers compared with non-carrier family members and controls. The investigators hypothesize that glycine, but not placebo, will improve positive, negative and affective symptoms as well as neurocognitive function. The investigators also hypothesize that open-label glycine will improve clinical and cognitive functioning, will partially normalize decreased baseline glycine and GABA and increased glutamate and glutamine, and will partially normalize magnocellular pathway activation and abnormal evoked potentials.