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About_Research

Depression Research Studies

Is Your Depression Treatment Resistant?

We are conducting this study to see if diazoxide can quickly improve depressive symptoms in people with treatment-resistant major depressive disorder (MDD).

Adults 18 to 65 years old with MDD, who are currently depressed without psychotic features will be enrolled and hospitalized for the entire study. They may be allowed short leaves.

This research aims to see if diazoxide (an enhancer of glutamate transporter function) versus placebo can rapidly improve overall major depressive symptoms in patients with treatment-resistant Major Depressive Disorder (MDD). Other goals of the study include: evaluating diazoxideâ��s effect on glutamate levels in the brain, determining whether changes in brain neurochemicals correlate with antidepressant response, and examining other biomarkers of response.     

This inpatient study is assessing the effectiveness of the oral medication diazoxide (an enhancer of glutamate transporter function) versus placebo to rapidly improve hard-to-treat major depressive symptoms. The study enrolls eligible participants ages 18-65, who are diagnosed with Major Depressive Disorder (MDD), have previously failed to respond to treatment, and are free of other serious medical conditions.

This study can last up to 12 weeks and is 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 are provided and costs are covered by NIMH (arrangements vary by distance). After completing the study, participants receive short-term follow-up care at the NIH while transitioning back to a provider.

Depressed people appear to have problems regulating levels of a brain chemical called glutamate than people who are not depressed. The drug diazoxide may help regulate glutamate levels in people with depression. Researchers want to know if it can rapidly improve depression symptoms. This would help many people with depression, because most medications take a long time to work.

Objectives: To see if diazoxide can quickly improve depressive symptoms in people with treatment-resistant major depressive disorder (MDD).     

Participants will be interviewed many times during the study. They will also fill out questionnaires.

Phase I will last about 4 weeks. Participants will be screened with lab tests, and psychiatric and medical history and exams. Participants will slowly go off current medications. They will be drug-free for 2 weeks.

Phase II will last about 8 to 9 weeks. Participants will be monitored, answer questions, and give blood samples. They will drink a glucose drink, give saliva samples, and have scans of their brains taken. Participants will take the study drug daily by mouth for one 3-week session. They will take a placebo daily by mouth for the other 3-week session.

There will be a drug-free period of 14 to 21 days between sessions.        

Inclusion Criteria:

  • Individuals 18 to 65 years of age.
  • Women of child bearing potential must have a negative serum pregnancy test and confirmed (by the investigator) use of 2 effective methods of contraception (see below).
  • Each subject must be capable of understanding all required tests and examinations and sign an informed consent document.
  • Subjects must fulfill DSM-IV criteria for MDD, single episode or recurrent without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P). Subjects must be experiencing a current major depressive episode of at least 4 weeks duration.
  • Subjects must have an initial score of at least 20 on the MADRS at screening and at baseline of study phase I.
  • Subjects must have a current or past history of lack of response to two adequate antidepressant trials (may be from the same chemical class) operationally defined using the modified-Antidepressant Treatment History Form (ATHF).    

Exclusion Criteria:

  • Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV.
  • Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months.
  • Head injury that results in loss of consciousness exceeding 5 minutes (for the imaging component of the study).
  • Subjects with a DSM IV Axis II diagnosis of borderline or antisocial personality disorder.
  • Pregnant or nursing women or women of child bearing potential not using 2 medically accepted means of contraception (to include oral, injectible, or implant birth control, condom, diaphragm with spermicide, intrauterine devices (IUD), tubal ligation, abstinence or partner with vasectomy).
  • Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  • Subjects with hyperthyroidism or clinical hypothyroidism.
  • Subjects with one or more seizures without a clear and resolved etiology.
  • Clinically significant abnormal laboratory tests (including blood glucose).
  • Diabetes
  • Fasting plasma glucose concentration > 120 mg/dl
  • Upright blood pressure < 60mmHg on three occasions 30 minutes apart (based on scheduled research measurements).
  • Treatment with a reversible MAOI within 4 weeks of study phase II.
  • Treatment with fluoxetine within 5 weeks of study phase II.
  • Treatment with any other disallowed concomitant medication 14 days before randomization.
  • Treatment with clozapine or ECT within 1 month of randomization.
  • Lifetime history of deep brain stimulation.
  • Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.
  • Positive HIV test
  • Contraindications to MRI (metal in body, claustrophobia, etc)      

For Inquiries about our studies, please contact:

Libby Jolkovsky, M.S.
301-402-9347
jolkovsl@mail.nih.gov

http://www.nimh.nih.gov/labs-at-nimh/join-a-study/index.shtml


The Neurophysiological Effects of Intravenous Alcohol as Potential Biomarkers of Ketamine as  a Rapid Antidepressant Effects in Major Depressive Disorder

Date: November 14, 2014

We are conducting this study to see if the antidepressant effects of ketamine are different in those who have relatives with alcoholism. We will also test if depressed subjects who have relatives with alcoholism respond differently to alcohol. Finally, we will see if there are unique signatures in the response to ketamine and alcohol. This may help us develop a more personal approach to depression treatment.     

Glutamate-based medications including the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine result in rapid, robust and sustained (up to one week) antidepressant effects in randomized controlled trials in treatment-refractory unipolar1-3 and bipolar depression4, 5.  Previous work by our group has demonstrated that a family history of alcohol dependence predicts a more robust antidepressant response to ketamine in both treatment-resistant unipolar6 and bipolar7 depression.
Recently-detoxified alcoholics and affected first-degree relatives display blunted psychotomimetic, cognitive and other neuropsychiatric effects with a subanesthetic dose of ketamine.  Also, a family history of alcoholism alone predicts differential response to intravenous alcohol 8-10.  Based on our prior post hoc results, we seek to prospectively  demonstrate that a family history of alcohol dependence predicts a more robust antidepressant response to ketamine.  We will also explore potential biomarkers of ketamine�s antidepressant effects in treatment-refractory depressed patients at risk of alcohol dependence (using physiological and neurochemical responses to alcohol).     

We are enrolling participants  ages 21-65 year old with treatment-resistant major depressive disorder without psychotic features patients in a current major depressive episode of at least moderate severity will be recruited and enrolled in this protocol.  All subjects must also be free of a lifetime substance use disorder diagnosis with the exception of a nicotine or caffeine use disorder) and will be psychotropic medication-free for at least two weeks prior to the first alcohol infusion.  negative subjects.     

This study is a single-site, open-label protocol in psychotropic medication-free depressed subjects admitted to the Clinical Research Center�s Mood and Anxiety Disorder Inpatient Research Unit (7-SE).  This protocol consists of two phases (Phase I and Phase II). The first phase consists of the medication taper and drug-free period.  The second phase will have three subphases: Subphase IIA infusion #1 with neurophysiological assessments), IIB alcohol infusion #2 during 7 Tesla-Magnetic Resonance Spectroscopy/Imaging (7T-MRS/I)] and IIC (subanesthetic/antidepressant dose ketamine infusion during 7T-MRS/I).     

Inclusion Criteria:

  • Individuals ages 21 to 65 years of age.
  • A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding by a score greater than or equal to 90% on the consent quiz.
  • DSM-IV-TR diagnosis of MDD, single-episode (296.30) or recurrent (296.20) without psychotic features based on clinical assessment and confirmed by a Structured Clinical Interview for the DSM-IV- Patient Version (SCID-P). Subjects must be experiencing a current major depressive episode of at least 2 weeks duration.
  • Past failure of greater than or equal to two standard antidepressant trial based on the Antidepressant Treatment History Form (ATHF).
  • MADRS score greater than or equal to 20 at baseline and the day of ketamine infusion.     


Exclusion Criteria:

  • Inadequate knowledge of family mental and substance use history, e.g. adoption.
  • Current psychotic features or prior diagnosis of a DSM-IV-TR psychotic spectrum disorder, e.g. schizophrenia, schizoaffective disorder, bipolar I disorder with psychotic features, MDD with psychotic features, or bipolar disorder, e.g. bipolar I disorder without psychotic features, bipolar II disorder and bipolar disorder not otherwise specified (NOS).
  • Lifetime history of DSM-IV-TR drug or alcohol use disorder (except for caffeine or nicotine dependence), currently seeking or have a prior history of seeking help for alcohol problems, non-drinkers (no alcohol in the past year) and history of alcohol-induced flushing reactions.
  • Pregnant or nursing women or women of child bearing potential not using at least one medically accepted means of contraception (to include oral, injectable, or implant birth control, condom or diaphragm with spermicide, intrauterine devices (IUD), tubal ligation, abstinence or partner with vasectomy).
  • Serious, unstable medical conditions/problems including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, e.g. uncontrolled asthma, uncontrolled hyper/hypothyroidism or active cancer.
  • Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
  • Clinically significant abnormal laboratory tests.
  • Subjects with one or more seizures without clear and resolved etiology and head injury with loss of consciousness for > 5 minutes or requiring hospitalization.
  • Treatment with psychiatric medications, e.g. selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, benzodiazepines and antipsychotics, at least two weeks of study phase II
  • Treatment with fluoxetine within 4 weeks of study phase II.
  • Treatment with device-based treatment for depression, e.g. electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) and vagal nerve stimulation (VNS), within 4 weeks of study phase II.
  • Lifetime history of deep brain stimulation.
  • Treatment with any disallowed concomitant medications.
  • Positive HIV test
  • Presence of ferromagnetic implants, e.g, heart pacemaker or aneurysm clip, or other contraindications to magnetic resonance imaging (MRI), e.g. claustrophobia or hearing loss.
  • Clinically-significant anatomical brain abnormalities detected on routine brain MRI.
  • 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.
    Additionally, the Investigators may exclude or terminate any patient for clinical reasons.   

For Inquiries about our studies, please contact:

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


Depression Treatment Not Working?

KU Wichita Clinical Trial Unit researchers are looking for adults (ages 18-65) who are suffering from depression to participate in a research study offering a cutting edge treatment.  To participate the current depressive episode must last at lasted eight weeks.

Those who qualify will receive:
• Study related mental health assessments
• Physical exams
• Lab Assessments
• Study Medication

To see if you qualify, call 316-293-1833.

Trial Investigators: Dr. Matthew Macaluso and Dr. Sheldon Preskorn


Depression Treatment Options: What Matters Most?

Date: September 2, 2014

Have you ever suffered from depression? Voice your opinions to help improve the quality of depression care for patients across the United States.

We are researchers from Dartmouth College conducting a national survey to better understand what is important to patients when making decisions about depression treatment. Responses are anonymous and confidential. For more information or to take the survey, please go to: http://tinyurl.com/patient-treatment-survey.


Major Depressive Disorder Research Study

Date: August 26, 2014

If you are an adult with depression and are still experiencing symptoms while taking an antidepressant, consider participating in the MOSIAC clinical research study.  Visit the website to learn more and see if you may qualify.

For more information, please contact the Treatment Research Center at Rush University Medical Center in Chicago: 312-942-6597


Does Your Child Suffer From Depression?

We are looking for adolescents age 12-17 who are suffering from Major Depressive Disorder (MDD) to participate in a new Clinical Research Trial.

Purpose: To find out if an investigational drug is safe and to learn if it works for adolescents who have major depressive disorder (MDD).

FOR MORE INFORMATION CONTACT:

Kennedy Krieger Institute 443-923-3850

716 N. Broadway Baltimore, MD 21205

Robert Findling, M.D., M.B.A., Principal Investigator

NA_00086408, clinicaltrials.gov (NCT01878292)


Have you tried antidepressants and are you still struggling with depression?

Date: January 13, 2014

If so, please contact us about our 13-week research trial of an investigational, non-medication treatment for depression.

You may be able to participate if:

  • You are 18 to 70 years of age
  • Antidepressants have not fully relieved your depression symptoms or if you are unable to tolerate the side effects of your antidepressant

Qualified participants receive:

  • Study-related care and study treatment at no cost
  • Compensation for time and travel

To learn more, please visit: http://clinicalconnection.com/PatientViewStudy21720.aspx.


Depression and Anxiety Make Ghosts of Us All

Date: January 10, 2014

Childhood depression and anxiety greatly impact the lives of sufferers, taking away their ability to enjoy their childhood and making them a ghost or shadow of their former selves. We want to change this. We’re conducting ADVANCE – a clinical research study looking at how an investigational treatment called Lu AA21004 is processed in the body over time in children aged 7 to 17 years (inclusively) with depression or anxiety. Study–related treatments and procedures will be provided at no cost to you.

Please contact the study coordinator at 443-923-3850 to learn more.

Principal Investigator: Robert L. Findling, M.D. M.B.A.


Feeling depressed?

Date: September 16, 2013

It may be time to consider your options.

A Clinical Research Study for an investigational medicine is enrolling people who

  • Are currently taking an antidepressant but still need additional relief

    or

  • Are not taking antidepressant medications but think they may have depression

What is involved?

  • Qualified participants will receive study medication and study-related medical care at no cost.
  • Receive study related care by doctors who are currently treating depression
  • Take an active role in your own healthcare

Compensation for time and travel may be provided

Minimum Qualifications

  • An adult between 18 and 65 years old
  • Currently experiencing symptoms of depression
  • Willing to take the study medication along with a prescribed antidepressant medication

The study doctor can tell you if you meet all the study eligibility requirements.

Sad all the time. No energy. Feeling worthless. Trouble sleeping. Can’t focus. If you are experiencing these symptoms, this study may be right for you.

To learn more and find out if you may qualify, please visit www.DepressionStudies.com http:// www.DepressionStudies.com



Feeling depressed?

Take part in a research study of an investigational medicine at no cost.

To qualify you must be :

  • Ages 19 to 65. </ li>
  • Willing to take study medication and antidepressant.

For more information contact Premier Psychiatric Research Institute at (402) 476-6060 (Option 4) and www.PremierPsych.com. 



Date: March 5, 2013

New Study Seeks Answers to Help People with Psychotic Depression

Most of us have heard of depression, but few people may know about a type of depression that appears along with psychosis (or a loss of touch with reality). Referred to as psychotic major depression (PMD), it’s a surprisingly common mental disorder that affects more than one in 100 individuals. If you or someone in your life has depressed feelings along with ideas or ways of thinking that are not true and/or see or hear things that aren’t there – it may be PMD. With PMD for example, people may hear voices telling them that they don’t deserve to live. There is a high risk of suicide for individuals with PMD so it’s critical to seek help and get treated immediately. [Note: If you have thoughts of suicide or harming yourself or others, immediately call 911 or go to your nearest hospital emergency room. You also may call a confidential suicide hotline from anywhere in the United States, 24 hours a day, seven days a week at 1-800-273-TALK (8255).]

People with PMD can and do get better with treatment. A combination of antidepressant and antipsychotic medication is an effective medication treatment.

In a new study called STOP PD II, researchers are working to understand how long people need to stay on an antipsychotic medication to prevent new episodes of psychosis after recovering from their initial symptoms. Individuals in this study will first receive a combination of an antipsychotic medication and an antidepressant medication for up to 20 weeks. They may begin in an inpatient or outpatient setting. Individuals who are nearly or fully better after up to 20 weeks will be invited to participate in a second phase of the study that lasts for up to 36 weeks.

To be eligible for the study, individuals must be 18 to 85 years old, experiencing symptoms of depression with psychosis, and not be pregnant. Study participants receive medication and medical care at no cost.

For more information about voluntary participation in this study call: Joelle M. Scanlon, PhD, at 412-246-6012


Date: January 24, 2013

Feelings in the Family Study

Are you:

  • A mother of one or more children between the ages of 6 to 12 years?
  • Experiencing feelings of depression?

Researchers in the Department of Child and Adolescent Studies at Cal State Fullerton are conducting a study to better understand how family members get along when a parent is experiencing some depressive feelings.

Participation includes a phone interview and questionnaires by mail. Families are compensated $25 for their time.

For more information, contact Marian Howland at (657) 278-1088 or mhowland@csu.fullerton.edu.


Date: January 8, 2013

Are you a woman between the ages of 45 and 55 and entering the transition to menopause?

The PERT (Perimenopausal Estrogen Replacement Therapy) Study is a clinical research study investigating cardiovascular health and psychological well-being during the menopause transition.

The PERT Study is enrolling two groups of women:

  • Women who have had more than one experience with depressive episodes in the past but who are currently not suffering from depression; and
  • Women who have never suffered from depression.

Eligible women will be randomly assigned (i.e., by chance) to either transdermal ERT (a skin patch containing 17b-estradiol) or placebo (a skin patch containing an inert substance). Participants will be involved in the study for 12-13 months with an optional 12 month follow-up period. Approximately 10 visits will be necessary over the initial 12-month period.

You may be eligible to participate if you are:

  • Living in North Carolina
  • Between the ages of 45 and 55
  • Medically healthy
  • Experiencing symptoms of the transition to menopause, such as irregular or absent cycles, hot flashes, etc.

What will you receive if you participate?

  • $1,325 for completing the full 12-month enrollment protocol and an additional $100 for the 12-month follow-up period.
  • 1 to 2 free screening mammograms
  • Free gynecological exam
  • Free medical screenings, including monitoring of glucose and lipid levels
  • Educational materials regarding health and well-being

For more information, click here www.pertstudy.com to visit our study website or please call:  (919) 972-7495


Date: Nov. 2, 2012

Is your major depressive disorder (MDD) a daily challenge?

Have you tried medications for your depression in the past which didn’t seem to help?
Are you currently taking an antidepressant but still feel low, tired, and depressed?

The Pursuit study is currently being conducted in your area to determine how safe and effective an investigational medication is for treating MDD.

We are looking for patients who:

  • Between the ages of 18-70, inclusive
  • have been diagnosed with MDD
  • have severe depressive symptoms but are not hospitalized
  • have tried at least three different antidepressants to treat their MDD over their lifetime which didn’t seem to help
  • are currently taking one or more antidepressants

The study will last for 20 weeks and will require approximately 20 visits to the study center so that study doctors and nurses can perform various tests and monitor how the drug affects you. Qualified participants will receive all study-related office visits, medical examinations, and investigational medication at no cost. Additionally, the cost of your currently prescribed medications for depression may be supplemented during your study participation.

For more information, click here www.majordepressionstudy.com to visit our study website or please call:  1-888-643-2056


TRIADE – Antidepressant Clinical Trial

Date: Oct. 6, 2011

The TRIADE trial is designed to assess amitifadine, a new drug being developed as a possible new antidepressant intended to reduce many of the side effects associated with typical antidepressant medications.

Who Can Participate in TRIADE?

  • People who have major depressive disorder
  • People who have not responded adequately to a single course of a previous antidepressant medication (SSRIs or SNRIs)

What is amitifadine?

  • Amitifadine is an investigational medication to treat depression that acts on three chemicals in the brain

What can you expect if you participate in TRIADE?

  • TRIADE is a 13 week trial
  • The purpose of the study is to assess the safety and effectiveness of the investigational medication
  • Some participants will be given amitifadine, while some will get a standard treatment and some will be given a pill with no medication (a placebo) for comparison

The trial will be conducted at approximately 30 centers throughout the U.S., and is expected to include approximately 318 individuals.

For full enrollment criteria and to locate a center near you, please call 1 (888) 414-1808 or visit www.trialreach.com/premium/depression.

TRIADE is sponsored by Euthymics® Bioscience, Inc., maker of amitifadine.

 

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