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.


Brexpiprazole (OPC-34712)

A Multicenter, Randomized, Double-blind Trial of Brexpiprazole versus Placebo for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder.

Participants who have received psychotropic medications in past 7 days (other than benzos) and had electroconvulsive therapy in past 7 days are ineligible. Approximately 60% of participants will be randomized in North America and 40% in Europe.

Contact
Heather Strobel
219-293-3860
heather@leapcure.com
website

Deadline for Enrollment: July 2019


Comparison of Two Forms of Oxcarbazepine for the Treatment of Bipolar Depression (Boston, MA)

Eligible participants with bipolar depression will be randomized to open treatment with immediate release or extended release Oxcarbazepine while remaining under the care of their existing local clinician.

Exclusions: Anti-anxiety medications exceeding equivalent of lorazepam 2mg/day, long-acting injectable antipsychotics, >1 dopamine-blocking agent, >1 antidepressant, FDA approved treatments for BPD, and/or ECT.

Contact
Greg Sachs
617-934-6757
collaborative.care@gmail.com
website

Deadline for Enrollment: 12/31/18


Bipolar-Schizophrenia Network for Intermediate Phenotypes: Psychosis and Affective Research Domains (Dallas, Texas)

The purpose of this multi-site research collaboration (Bipolar-Schizophrenia Network on Intermediate Phenotypes, B-SNIP) is to test the appearance of biological markers for psychosis and affect across the schizophrenia/bipolar diagnostic boundary and to examine the genetic associations for these biological markers.

Contact
Asha Philip
214-648-5276
asha.philip@utsouthwestern.edu

Deadline for Enrollment: June 30, 2020


BiAffect: a ResearchKit study to unobtrusively understand mood and cognition in bipolar disorder (iPhone)

Currently, diagnosis and treatment of bipolar disorder rely on careful history taking and mental status examination by an experienced clinician, at times aided by self-report or family-informed questionnaires. These reports, as well as in-person assessments, have to be interpreted by providers in order to extract patterns that could indicate an imminent change in mood. When individuals experience changes in mood, they also may struggle with navigating daily activities—especially ones with high cognitive demand.

With the expanding coverage of wireless Internet access and rapid advancement of mobile smartphone technologies, people are increasingly interacting via typed (rather than oral) communications. BiAffect's innovative approach aims at understanding and examining the ubiquitous 'virtual mental-health footprints' or 'signatures' of abnormalities in people suffering from mood disorders, notably abnormalities in cognitive skills.

Contact
BiAffect@psych.uic.edu
https://itunes.apple.com/us/app/biaffect/id1355144276?mt=8
http://www.moodchallenge.com/

Deadline for Enrollment: Rolling


Treatment of Patients with Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (San Diego, CA)

The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study is 6 weeks long and requires a visit to the office once a week.

Inclusion Criteria:

- male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder
- experiencing a current major depressive episode
- treatment with either lithium or valproate and inadequate therapeutic response of depressive symptoms

Exclusion Criteria:

- any subject unable to provide informed consent
- any female subject who is pregnant or breastfeeding
- any subject judged to be medically inappropriate for study participation


Contact
Linda Dalton, M.A.,LPCC
619-303-6130
daltonl@synergyeastinc.com

Deadline for Enrollment: February 2019


Lithium Effects on the Brain's Functional and Structural Connectome in the Treatment of Bipolar Disorder (Cleveland, OH)

Study participation will include 12 office visits across 26 weeks. The purpose of this study is to investigate and map the functional effects of lithium treatment on the nervous system in patients who have bipolar disorder. Lithium is FDA approved and highly effective in the treatment of bipolar disorder, however, despite decades of research, its clinical mechanism of action remains unclear. To conduct this study, a functional MRI will be used to measure brain activity by detecting changes associated with blood flow at four time points across the 26 weeks. All participants must be willing to be treated with only Lithium as a single mood stabilizer for 6 months. No other psychotropic medications may be taken during the duration of the study. All participants will be compensated for their time of participation in the study. Also seeking healthy volunteers with no history of a mood disorder.

Inclusion criteria for Bipolar Disorder participants:

  • Ages 18-60 years (inclusive) and able to give voluntary informed consent
  • Meeting diagnostic criteria for Bipolar Disorder type I or II, current Depressive Episode
  • Not currently (hypo)manic
  • No psychotropics in the last 2 weeks (if previously on fluoxetine then medication free for  5 weeks)
  • No lithium treatment for past 6 months
  • Ability to undergo an MRI scan
  • No significant suicidal or homicidal ideation or gross disability

Exclusion criteria for Bipolar Disorder subjects are:

  • Meeting DSM-IV criteria for schizophrenia, schizoaffective disorder, or an anxiety disorder as a primary diagnosis
  • Requiring inpatient treatment
  • Meeting DSM-V criteria for substance dependence within the past year, except caffeine or nicotine
  • Positive urinary toxicology screening at baseline
  • Use of alcohol in the past 1 week
  • Serious medical or neurological illness
  • Current pregnancy or breast feeding
  • Metallic implants or other contraindications to MRI.

Participants must be currently depressed and not on any medications or treatments for their depression leading up to the MRI.

There is no experimental medication involved. All participants are prescribed Lithium, an FDA approved mood stabilizer and will be followed up and treated for a 6 month time period.

Contact
Amy Morrison or Lauren Patterson
216-445-2378 or 216-636-1675
moodres@ccf.org

Deadline for Enrollment: October 2022


Online, recovery-oriented bipolar individualised tool (ORBIT) project: Comparison of two interventions to improve quality of life in bipolar disorder

We are trialling online self-help programs for people with bipolar disorder. These programs have been created by international experts to improve quality of life for people who experience bipolar disorder, and include: videos, exercises, tools, forums, and access to a personal online coach. Your participation would involve engaging in a 5-week online program with ongoing access for 6 months, and participating in 4 paid research assessments, which are conducted over the phone. If you are aged between 18 and 65, have been diagnosed with bipolar disorder, have had 10 or more mood episodes in your lifetime, and are keen to improve your quality of life, you may be eligible to participate.

Participants will be randomised (1:1) to one of two brief (5week) online guided self-management interventions: Mindfulness for Bipolar compared with an active control condition of Psychoeducation for Bipolar.

Contact
Fiona Foley
ffoley@swin.edu.au
orbitonline.org

Deadline for Enrollment: February 2019


Risk and Resilience Study (Palo Alto, CA)

Have you been diagnosed with mania, manic depression, or bipolar disorder and are the parent of a healthy 8-17 year old child?

Parents and their children are needed for a study that explores the brain and emotional predictors of resilience to mood problems in children and adolescents.

The study takes place in the Department of Psychiatry and Behavioral Sciences at Stanford University. You and your child would participate in interviews, your child would do some activities on a computer, and even have a noninvasive MRI scan taken of his/her brain.

Eligible families will be paid for their time. The study will last approximately 6 hours over the course of two visits. We will schedule the sessions around your availability.

To be eligible for this study, the parent must:

  • Have been diagnosed with bipolar disorder
  • Have no other neurological conditions

The child must:

  • be age 8- 17 years old
  • have no known psychiatric illness
  • have no braces or metal in his or her body
  • be a US citizen or non-citizen with a Green Card
  • read and speak English
  • have no immediate plans to leave the Bay Area

Contact
Danielle Wall
650-721-4049
thepearlab@stanford.edu

Deadline for Enrollment: 09-01-2018


Evaluation of NeoSync EEG Synchronized TMS For the Treatment of Major Depressive Episode in Bipolar Disorder and Associated Neural Response: An Open Label Trial (Providence, Rhode Island)

Adults with Bipolar I Disorder who struggle with symptoms of depression despite medication treatments recieve a diagnostic evaluation and (if eligible) up to 30 daily treatment sessions (weekdays over 6 weeks) with an investigational device that delivers Transcranial Magnetic Stimulation ("TMS")  synchronized with the participant's alpha brain waves. Participants may also have a functional Magnetic Resonance Imaging (fMRI) brain scan before and at the end of the clinical trial. Participants remain on their stable psychiatric medication regimens, and the TMS treatments are "active" for all study participants, i.e. no one will get "placebo" or "sham" TMS.

Participants will not be able to change medications during the 6 weeks of the study unless medically necessary.

Contact
Dr. Jorge Almeida
401-455-6623
jalmeida@butler.org

Deadline for Enrollment: TBD


Dynamic Inflammatory and Mood Predictors of Cognitive Aging in Bipolar Disorder (San Diego/La Jolla, CA)

UCSD Department of Psychiatry is conducting research on how short-term changes in inflammatory markers (signs of healing response) and emotion contribute to long-term changes in thinking in bipolar disorder.

The study includes:
- Daily smartphone surveys and wearing an activity-monitoring watch for 2 weeks
- Clinical interviews and health questionnaires
- Testing on memory, attention, and learning tasks
- 3 blood draws (15 mL each)

Inclusion criteria:
- Diagnosed with bipolar I disorder
- Between the ages 35 and 60 years old

Compensation is up to $165 for approximately 10 hours per year, spread out over 3 separate visits in a 2-week period. The study lasts for four years. The primary location is in La Jolla, but home visits and transportation may be available.

Contact:
Nana Kori
858-534-9439
nkori@ucsd.edu

Deadline for Enrollment: April 2020


Neural mechanisms of perception across the schizo-bipolar spectrum (Newark, NJ)

As part of this study, participants will be asked questions regarding their clinical/psychiatric history. In a separate session, participants will enter an fMRI scanner and perform behavioral tasks while looking at a screen. Participants will be compensated $20-$30 per hour for each session. Total compensation for completing the study could be $90-$200.

Contact
Lisa Cruz
973-972-0084
lisa.cruz@rutgers.edu

Deadline for Enrollment: 3/31/2020


Clinical Medication Development for Bipolar Disorder and Alcohol Use Disorder (Miami , Florida)

The University of Miami, Miller School of Medicine Department of Psychiatry and Behavioral is conducting a 14-week research study to see if two nutritional over-the-counter supplements help improve mood and reduce alcohol consumption in individuals diagnosed with Bipolar Disorder and Alcohol Use Disorder. Participation is confidential.
Participants may continue on their medications and have a 1 in 3 chance of receiving Pregnenolone, Citicoline, or placebo.

Contact
Yamila Carmona, MA
305-243-2686
yic3@med.miami.edu

Deadline for Enrollment: January 2020


A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating the Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression (Hoffman Estates, IL)

You may be eligible to participate in this study if you are between 18-65 years old, have been diagnosed with Bipolar I Depression, are currently suffering a major depressive episode that has lasted more than 4 weeks but not longer than 12 months. This study lasts approximately 9 weeks, including a screening period of up to 14 days, followed by a 6 week treatment period and 1 week safety follow-up period.

Exclusion criteria includes prior participation with any clinical trials, involving experimental or investigational drugs, within 6 months. Initiation or termination of psychotherapy for depression within the 3 months. Treatment period is 6 weeks where participants will be randomized to receive either 1.5mg , 3.0mg of study drug or placebo.

Contact
Linda Orgler
Phone: 847-230-3591
Email: PsychResearch@amitahealth.org
www.AlexianResearch


Bipolar and Schizophrenia Network for Intermediate Phenotypes (Chicago, IL)

The overall goal of this study is to test for biological traits of psychosis that may be related to disorders ranging from schizophrenia to bipolar disorder. In addition, we wish to examine whether these biological traits may be genetically inherited.

People ages 18-60 diagnosed with at least one of the following:

  • Schizophrenia
  • Schizoaffective disorder
  • Bipolar disorder with psychotic features

Participants will undergo clinical interview, cognitive testing, self-report questionnaires, one-time blood-draw to study DNA, EEG, Eye Tracking Movement recording and fMRI testing.You will receive a confidential, no-cost, evaluation to see if you qualify to enter. If eligible, you will receive a full clinical assessment at no cost. Compensation: Up to a maximum of $360.00 which includes $10 per visit travel reimbursement.

Contact
Barrett Kern
Phone: 773-834-6835
Email:bkern@yoda.bsd.uchicago.edu
http://bsnip.uchicago.edu/

Deadline for Enrollment: 2/12/2020


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. 

Contact
Allison Metts
Phone: 646 774 7560
Email: almetts@nyspi.columbia.edu
www.bipolarimaging.org

Deadline for Enrollment: 9/30/2019


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.

Contact
Rebecca Hinton
Phone: 443-923-3850
Email: researchtrials@kennedykrieger.org


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

  1. Male or female subjects, 18 to 55 years of age.
  2. Age of onset less than 40 years of age.
  3. Female subjects of childbearing age must be using a medically accepted method of contraception.
  4. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
  5. Subjects must fulfill DSM-IV criteria for Major Depression single episode or recurrent without psychotic features, or Bipolar Disorder (296.5 for Bipolar I Disorder or 296.89 for Bipolar II Disorder) without psychotic symptoms based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P).
  6. Subjects must have an initial score on the MADRS of at least 20 at screening, and at baseline for Phase I of Substudy 4. Subjects with bipolar disorder must have a YMRS of 12 or less at baseline for Phase I.
  7. Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial.
  8. Current major depressive episode of at least 4 weeks duration.
  9. In women of childbearing age, a negative pregnancy test within 24 hours of MRI.

Exclusion criteria for participants with MDD or BD

  1. Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV.
  2. Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine    dependence) within the preceding 3 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not  have used illicit substances in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines) urine test at screening.
  3. Female subjects who are either pregnant or nursing.
  4. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  5. Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
  6. Clinically significant abnormal laboratory tests.
  7. Subjects with clinical hypothyroidism or hyperthyroidism.
  8. Subjects with one or more seizures without a clear and resolved etiology.
  9. Treatment with a reversible MAOI within two weeks prior to Phase I of Substudy 4.
  10. Treatment with fluoxetine within five weeks or aripiprazole within three weeks before Phase I of Substudy 4.
  11. Treatment with any other concomitant medication (Appendix 4) 14 days prior to Phase I of Substudy 4.
  12. Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip).
  13. Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score of >4.

Inclusion criteria for control subjects

  1. Age 18-55 years.
  2. Written informed consent completed.
  3. In women of childbearing age, a negative pregnancy test within 24 hours of MRI.

Exclusion criteria for control subjects

  1. Current or past Axis I diagnosis
  2. Presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips).
  3. Presence of medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
  4. Treatment with any of the exclusionary medications detailed in Appendix 4 14 days prior to Phase 1 of the Substudy 4.
  5. Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine).
  6. Presence of psychiatric disorders in first-degree relatives.
  7. Female subjects who are either pregnant or nursing.

Contact:
Libby Jolkovsky, M.S.
Phone: 301-402-9347
Email: jolkovsl@mail.nih.gov
http://www.nimh.nih.gov/labs-at-nimh/join-a-study/index.shtml


NIH Research Studies: Bipolar Disorder & Severe Irritability Symptoms (Bethesda, Maryland)

How do the brain and the symptoms change as children grow up?
(Enrolling Nationwide, Eligible Participants Ages 6-17)


Researchers will describe over time the moods and behavior of children use specialized testing and brain imaging to learn about specific brain changes associated with bipolar disorder or severe irritability in children. Studies involve 1-5 outpatient visits, with follow up visits as the child grows up. All clinical evaluations, research procedures, and outpatient visits are free of cost. Children and parents are compensated for participation. Travel and lodging expenses are paid by NIMH.

Participants must have a bipolar diagnosis, or have symptoms of severe irritability. Irritability symptoms include: difficulty handling frustration (severe temper tantrums and rages) and "hyper" behavior (distractible, hyperactive, trouble sleeping).

Call for more information and eligibility criteria.

Contact:
NIMH Irritable Kids
Phone: 301-496-8381, TTY: 1-866-411-1010
Email: irritablekids@mail.nih.gov
http://patientinfo.nimh.nih.gov/BipolarD

Deadline for Enrollment: Ongoing


Developing Brain Function in Adolescent (Chicago, IL)

Developing Brain Function in Adolescent Bipolar Disorder

This study focuses on the developmental changes in cognitive and affective neural circuitry functioning in adolescents with Pediatric Bipolar Disorder (PBD) over a three-year period. We will characterize the course of illness and associated neurocognitive function in patients with PBD as well as determine the association between brain function and behavior.

During the study, participants will complete a baseline diagnostic interview, clinical assessments, neurocognitive and neuropsychological tests, and a functional MRI brain scan. Participants will also have the option to draw blood for pharmacogenetic analyses. Testing will be repeated once a year for three years after the baseline visit, four visits total.

Contact:
Allison Lowes
(312) 355-1168
alowes@psych.uic.edu

Deadline for Enrollment: Ongoing