Research Studies: Bipolar Disorder
DBSA does not endorse nor recommend any particular research study. Patients should discuss all options with their health care providers and family members before beginning any study.
Many people think that participating in a research study means they will get better treatment for their illness. While this may be true, it's important to remember that a research study is conducted for research purposes—it does not ensure better or safer treatment.
Taking part in a study does not guarantee individual benefits to the participant in the form of newer or safer treatment. The contribution made participating in a research study is to science first and to the patient second.
DBSA, its advisors, and consultants do not endorse or recommend the use of any specific treatment or medication. For advice about specific treatment or medication, patients should consult their physicians and/or mental health professionals.
Efficacy of a Kappa Opioid Receptor Antagonist for the Treatment of Anhedonia in Patients with Mood and Anxiety Disorders (Durham, North Carolina)
The goal of this study is to assess the effects of a novel drug on anhedonia (the loss of pleasure) that is associated with mood and anxiety disorders. Study subjects will take the study drug (or placebo) daily for eight weeks, with study visits every two weeks. Including Screening and Follow-up visits, there are a total of seven visits over sixteen weeks. Study assessments include brain scans, blood draws, computer tasks, physical and psychological examinations. This study drug could potentially restore the ability to experience pleasure in patients with mood and anxiety disorders, which would be of particular benefit to those patients who do not respond well to traditional medications.
Participants may not use any antidepressant, antipsychotic, anxiolytic, anticonvulsant, mood stabilizing, muscle relaxant, centrally acting antihistaminergic, stimulant or insomnia medications while participating in the study.
50% of participants will be assigned to a placebo group for 8 weeks.
Deadline for Enrollment: September 10th 2016
Neurocognitive Study on Adolescent Drug Abuse (Chicago, IL)
I am conducting a study on brain development and marijuana use in adolescents with and without bipolar disorder. I have been conducting clinical research in pediatric bipolar disorder for several years and I consider this project very important because of the high comorbidity between bipolar disorder and substance use that often worsens life challenges for children and families. We are recruiting 14-18 years old adolescents with pediatric bipolar disorder, or without bipolar disorder, who have a significant problem with marijuana use (ex, they smoke marijuana 3-4 times a week).
The study is CONFIDENTIAL and the information collected will not be shared with anyone.
Participant must not be taking medication for a mental illness other than bipolar disorder, must refrain from other substance abuse up to two weeks before the day of the study, as there will be a drug test taken that day.
Deadline for Enrollment: 08/30/2016
Prediction of Clinical Response to SSRI Treatment in Bipolar Disorder Using Serotonin 1A Receptor PET Imaging (New York/NY)
The study is trying to understand what causes bipolar disorder and how medications treat bipolar depression. If you participate, you will have two different brain scans (an MRI and a PET scan) and antidepressant treatment for free. We will then be able to see whether information on the brain scans connects with how people do on the medications. The medications are common, and are not experimental. You will be able to discuss the treatment with Dr. Lan before starting the study to make sure that it is the proper treatment for you. The medications include valproate (Depakote) and either fluoxetine (Prozac) or citalopram (Celexa). The study is funded by the National Institute of Health (NIH). You will receive $400 in compensation when you complete the brain scans and will be offered up to six months of free appointments with a Columbia psychiatrist.
Deadline for Enrollment:
Consumer Perspectives on Self-Management and the Use of Mobile Health in Bipolar Disorder (Online)
Researchers at The University of New South Wales and the Black Dog Institute are seeking volunteer research participants to learn about what YOU do to stay well, and how SMARTPHONES may help.
The study might be a good fit for you if you:
If you decide to take part you would answer questions about:
Completion of all parts of the survey will take approximately 20 minutes.There are no additional costs associated with participation in this research project, nor will you be paid.
To share YOUR VIEWS head to the online survey at: https://bdsurvey.blackdoghealth.org.au
Deadline for Enrollment: 3/01/2016
Pharmacoepigenetics of Second Generation Antipsychotic-Induced Insulin Resistance in Bipolar Disorder (Detroit, MI)
A research study on medications and their side effects in bipolar disorder is being conducted at Wayne State University. The study consists of two visits and two follow up phone calls. A total time of 5-7 hours is needed.In order to participate, individuals must meet the following criteria:
No changes will be made to your current treatment
Compensation: Up to $225
Deadline for Enrollment
BASIS - Bipolar And Social Factors in Suicidality (United Kingdom/Phone/Online)
Our work assesses the role of social relationships in leading to, worsening and protecting against suicidal thoughts, feelings and behaviours in people with a diagnosis of bipolar disorder. We also look at how mood changes and mood instability might mediate this relationship.
We hope that results will help us to better understand psychological mechanisms which underlie pathways leading to the development of suicidal thoughts, feelings and behaviours. This in turn will allow us to better inform psychological interventions which aim to target and reduce suicide risk in bipolar disorder.
Participation in the study involves a 30 minute phone interview with a trained researcher. This interview asks questions about mood episodes and mood symptom experiences. Next, participants are asked to complete some online questionnaires (approx 1 hour) which ask about characteristics of social relationships and past experiences of suicidal feelings. Participants are reminded to take breaks throughout the completion of these measures and complete a follow-up phone call with all participants to check that they found everything okay and aren't experiencing any distress as a result of the questionnaires.
For participants who don't have access to the internet, questionnaires can be posted out hard copy with a freepost envelope to return them. Finally, we ask participants to repeat the assessments in four months time.
Deadline for Enrollment: February 2016
A Phase 1, Multicenter, Open-label, Dose-Escalation Trial to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC-34712) in Adolescents with Schizophrenia or Other Related Psychiatric Disorders (Baltimore, MD)
This research study is being conducted by Kennedy Krieger Institute/centers across the United States to determine whether brexpiprazole is safe and effective in adolescents with schizophrenia or a related psychiatric disorder.
If eligible, the participant will visit the Kennedy Krieger Institute up to 9 times over a period of 102 days. Each visit will take between 30 minutes and 2 hours and will include psychological and behavioral testing, medical history, physical examination, blood draws, HIV testing, vital sign, ECG, urine drug screen, and pregnancy testing for females.
For each completed visit, participants will receive a reimbursement of $75.00 for their time and travel expenses. Please ask a study team member for specifics. All testing is done free of charge.
Please call 443-923-3850 for questions about specific co-ocurring treatments.
Rapid Antidepressant Effects of Ketamine in Bipolar Disorder (Bethesda, MD)
Bipolar disorder and major depressive disorder (MDD) are common, severe, chronic and often life-threatening illnesses. Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses. Recent preclinical and clinical studies suggest that the glutamatergic system is involved in the mechanism of action of antidepressants. In two separate trials, we tested riluzole (an inhibitor of glutamate release) and found it to have antidepressant properties in patients with MDD and bipolar depression (BD). In another study (Substudy 1), we found that the non-competitive NMDA antagonist (ketamine) was effective in treatment-resistant MDD. Ketamine resulted in rapid, robust and relatively sustained antidepressant effects. Response with ketamine occurred within 2 hours and last approximately 1 week. The current protocol consists of 6 subs tudies designed to address 6 major questions. Two of these studies (1 and 5) have met their enrollment quota and sufficient analyzable data has been obtained
Standard antidepressant medications can take weeks or months to achieve their full effects. Several studies seek to better understand the causes of depression and evaluate the mechanisms in the brain that are related to rapid antidepressant improvement. NIH studies enrolls depressed persons between the ages of 18 and 65 (or those with bipolar disorder who are currently in a depressive phase) for an inpatient period of 2- to 3-months. Researchers will evaluate how the experimental medication ketamine, versus placebo, affects glutamate in the brain and whether a rapid reduction of antidepressant symptoms (within hours) can be achieved and sustained.
The studies are conducted at the NIH Clinical Center in Bethesda, Maryland. There is no cost to participate. We enroll eligible participants locally and from around the country. Travel arrangements provided and costs covered by NIMH. (Arrangements vary by distance and by specific study.) After completing the study participants receive short-term follow-up care while transitioning back to a provider.
Participants who consent will have a multimodal MRI and MEG scan in the drug-free period before receiving the intravenous infusion of either ketamine or saline solution. They will repeat the MEG procedure 4-5 hours after each of the two infusions, and will repeat the MRI procedure between the day of infusion to two days following the infusion.
Participants who show an antidepressant response (50% reduction in MADRS) following infusion 1 or infusion 2 will undergo an interim assessment using the same MRI and MEG scan battery to assess relapse (if the response is lost) or sustained response (if the response is retained) 10 to 11 days post-infusion, depending on availability of scanning resources. Non-responders will undergo the interim MRI and MEG scan sessions at 10 to 11 days post-infusion as scan-time allows.
In a subset of 26 participants, total sleep deprivation (TSD) for 40 hours (7am to 11pm the subsequent day) will be investigated at the behavioral and neural level as a rapid acting antidepressant prior to Phase II of this study. Individuals who participate in this optional component of the subs study will require an additional 7 days for their drug free period. In the evening prior to the sleep deprivation period, participants will undergo a baseline 3T MRI (within 2 days of TSD) and a high field 7T MRI scan (within 2 days of TSD) to acquire images of the brain prior to sleep deprivation. This will be followed by one 7T scan after the sleep deprivation period toward the end of the 40 hour period, but before recovery sleep. During the MRI scan participants will play a simple reward-learning task and also perform a cognitive emotional task whereby emotional faces will be presented, while functional images are acquired. Additionally, two MEG scans and two sleep EEGs will be acquired to examine the electrophysiology of response and relapse. During the MEG scan participants will wear an MEG compatible EEG cap and leads. Total sleep deprivation will occur approximately 1 week following the beginning of the drug-free period.
Inclusion criteria for participants with MDD or BD
Exclusion criteria for participants with MDD or BD
Inclusion criteria for control subjects
Exclusion criteria for control subjects
Examination of Glutamate and mGluR5 in Psychiatric Disorders
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