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Clinical Trials 


Depression and Marital Problems in Senior Citizens

Are you or your spouse age 60 or older? Are you feeling down or depressed? Are you having marital problems?

If so, you may be eligible to receive free couple's therapy as part of a study of depression and marriage in older adults at Duke University Medical Center.

Depressed participants will receive free medical care and prescriptions for antidepressant medications.

To find out if you qualify for this research study, e-mail Heather Bergida at heather.bergida@duke.edu or call 919-286-5264  

(REF# 8636)

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Anxiety and Traumatic Stress Program
 

Ziprasidone for the Treatment of Refractory Social Anxiety Disorder

Research Study for those who suffer from Fear or Anxiety in Social Situations

Are you awake at night worrying about upcoming social events?


  


 

Do you have unreasonable fear or anxiety in work or social situations?

Do you avoid public speaking, talking to the boss, or meeting new people?

Do you blush, tremble, sweat or have racing heart in social situations?

If yes, you may be eligible for:

¨       Free medication treatment for your social anxiety

¨       Up to $300 Compensation


For More Information, call Nabila Lateef
, 919 684-9701

Study Doctor:  Dr. Wei Zhang
IRB# 6479

Duke University Medical Center
Anxiety and Traumatic Stress Program
Department of Psychiatry and Behavioral Sciences

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Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder  

Obsessive-Compulsive Disorder Research Study 

If you have Obsessive-Compulsive Disorder, you may be eligible to participate in a research study under the supervision of Dr. Wei Zhang at Duke University Medical Center’s Department of Psychiatry.

Symptoms of OCD may include:

Recurrent and persistent thoughts, impulses or images

Fears of being contaminated by dirt or germs

Feeling you must wash your hands repeatedly

Excessive checking of routine activities

Feeling you must repeat certain activities until it “feels right”

For more information call:
Nabila Lateef, study coordinator at 919-684-9701

Study Doctor: Dr. Wei Zhang

IRB# 7242
 

Duke University Medical Center
Anxiety and Traumatic Stress Program
Department of Psychiatry
and Behavioral Sciences   

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A Double-Blind, Randomized, Study of Escitalopram vs. Duloxetine: on Heart Rate Variability and Autonomic Cardiovascular Control in Subjects with Symptoms of depression. 

Are You Sad or Blue ?

Do you enjoy things less than you used to ?

If you are 20-60 years old, physically healthy and meet study criteria, you may be eligible to participate in a research study at Duke University Medical Center.

We are testing the effects of two antidepressants, Escitalopram and Duloxetine on measures of heart rate and blood pressure in people with symptoms of depression.  Medication, psychiatric and physical assessments will be provided free of charge. For more information, call Nabila Lateef, study coordinator, at 919- 684-9701.

Principal Investigator :  Dr. Wei Zhang
IRB# 6957

Duke University Medical Center
Anxiety and Traumatic Stress Program
Department of Psychiatry
and Behavioral Sciences    

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A Double-Blind, Randomized, Study of Paroxetine vs. Duloxetine: on Heart
Rate Variability and Autonomic Cardiovascular Control in Subjects
with Symptoms of Depression 

Are You Sad or Blue?

Do you enjoy things less than you used to?

If you are 20-60 years old, physically healthy and meet study criteria, you may be eligible to participate in a research study at Duke University Medical Center.

We are testing the effects of two antidepressants, Paroxetine and Duloxetine on measures of heart rate and blood pressure in people with symptoms of depression.  Medication, psychiatric and physical assessments will be provided free of charge. Study participants will be eligible to receive up to $120 in compensation for their time.  For more information, call Nabila Lateef, study coordinator, at 919- 684-9701.

Study Doctor:  Dr. Wei Zhang
IRB#  6956

Duke University Medical Center
Anxiety and Traumatic Stress Program
Department of Psychiatry
 and Behavioral Sciences   

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Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder

DO YOU WORRY A LOT?

Are you restless?
    Keyed up?
    On edge? 
    Easily fatigued?
    Irritable?

Does your mind go (       )blank?
Do you have muscle tension?
Do you have trouble sleeping?

If so, you may be eligible to participate in an investigational drug research study at Duke University Medical Center conducted by Dr. Wei Zhang. 

For further information please call Nabila Lateef, study coordinator, at 919- 684-9701.   $30 per completed visit if enrolled.   

Principal Investigator:  Wei Zhang, MD
IRB#     5589 

Duke University Medical Center
Anxiety and Traumatic Stress Program
Department of Psychiatry and Behavioral Sciences

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Escitalopram in Obsessive-Compulsive Disorder  

If you have Obsessive-Compulsive Disorder, you may be eligible for free treatment in a new research medication study under the supervision of Dr. Kathryn Connor at Duke University Medical Center’s Department of Psychiatry.

Symptoms of OCD may include:

Recurrent and persistent thoughts, impulses or images
Fears of being contaminated by dirt or germs
Feeling you must wash your hands repeatedly
Excessive checking of routine activities
Feeling you must repeat certain activities until it “feels right”

For more information call:
Nabila Lateef, study coordinator, at 919- 684-9701.

Study Doctor:  Dr. Wei Zhang
IRB# 5731
 

Duke University Medical Center
Anxiety and Traumatic Stress Program
Department of Psychiatry and Behavioral Sciences

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Post Traumatic Stress Disorder - Research Study

NIGHTMARES………….. SLEEP DISTURBANCE

AVOIDANCE OF REMINDERS…….FLASHBACKS

TROUBLE CONCENTRATING…..FEELING EDGY

If you have developed some of these symptoms following a traumatic event such as rape, incest, domestic violence, or serious accident or injury, you may be eligible to participate in a research study.

For further information on this or other current studies, please call

Nabila Lateef, study coordinator, at 919- 684-9701.

Study Doctor:  Wei Zhang, MD
IRB # 7031

Duke University Medical Center
Anxiety and Traumatic Stress Program
Department of Psychiatry and Behavioral Sciences

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Geriatric Depression

Depression in Older Adults

Dr. David Steffens in The Department of Psychiatry and Behavioral Sciences is conducting a five-year study of depression in older adults.  The study will involve interviews about every three months with a geriatric psychiatrist, as well as memory testing once a year, blood testing, and two magnetic resonance imaging (MRI) brain scans.

The study will take place at Duke Hospital. 

There is no cost for participation in the study.

If are 60 years or older, have depression and may be interested in the study,
please contact the study coordinator:  Ms. Cortnee Pierce at 681-3293.

Dr. Steffens’ office is located in Duke South Hospital, Room 3547.

Study Doctor:  David Steffens, MD
IRB #
0625 

Duke University Medical Center
Department of Psychiatry and Behavioral Sciences

                     

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We are now enrolling patients in a NIH-funded study at DUMC offering FREE Treatment for depressed older adults. Investigators: Thomas Lynch, Ph.D. (PI), John L Beyer, M.D., K. Ranga R.Krishnan, M.D.

Our study offers free FDA-approved medications and behavior therapy for difficult-to-treat older adults (age 55+) with major depression. All potential participants will be given a thorough diagnostic assessment. If you are interested in finding out more about the study or would like to refer a potential participant, please contact the study coordinator, Christine Vitt, at 668-0714.

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Bipolar Disorder Study

Do you have Bipolar Disorder?
(Previously known as manic-depression)

Researchers at Duke University Medical Center are looking for persons who have been clinically diagnosed with Bipolar Disorder to participate in a research study looking at brain structure and genetic factors of the disease.  Participants must be above the age of 18 years.

The study will involve a one-time visit and will take approximately four hours.  The visit will include: 

  • An MRI

  • An Interview

  • For women of childbearing potential, two tablespoons of blood will be drawn for a pregnancy test.

    Participants will be compensated $80 for their time.

 For additional information, please contact

Michelle L. Haller
Study Coordinator
Telephone (919) 668-2608

1/20/05                                                                                                          0785

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Bipolar Disorder - Treatment in Late Life Study 

Text Box: BIPOLAR DISORDER
Treatment in Late Life Study

 
    

        Have you been feeling unusually irritable or felt on top of the world?

          Have you been diagnosed with Manic-Depression or Bipolar Disorder?

 If you answered “yes” to the questions above, you may be eligible to participate in a research  study. 

The Duke University Medical Center is recruiting patients over the age of 60 currently experiencing the manic, hypomanic, or mixed symptoms of Bipolar Disorder to participate in a study comparing lithium and valproate. 

Participants will receive psychiatric assessments and medication at no cost and will be compensated $20 per study visit for time and travel. 

 If you or someone you know are interested in participating please contact:        

   Michelle Haller       OR           Mike Mani

  (919) 668-2608                      (919) 681-8362

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Dementia

Department of Psychiatry at Duke University Medical Center is taking part in a study of an investigational drug, which may delay the progression of Mild memory loss do to Alzheimer’s disease

  • Patients will receive:

    • Study medication and physician visits

    • Medical care

    • Monitoring

  • If you or someone close to you

    • Experiences mild memory loss

    • Increasingly cannot process new information or remember the names of common item

    • Has become socially withdrawn

    • And /or exhibits personality changes

    • Is between the ages of 55-85

Call Hala Husn at (919) 684-5929 for more information

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A Treatment Study of Youths with Comorbid Attention Deficit Hyperactivity Disorder (ADHD) and Anxiety Disorders

The purpose of this NIMH-sponsored pilot study is to collect information on the efficacy and
safety of pharmacological treatments for children and adolescents who suffer from both ADHD and anxiety disorders. Specifically, the study will examine the benefits of the stimulant medication methylphenidate (Ritalin) both alone and in combination with fluvoxamine (Luvox), a selective serotonin reuptake inhibitor (SSRI) that has anti-anxiety effects, for treating these co-occurring disorders in young people ages 6 to 17.

Many children and adolescents with mental disorders in the United States are treated with multiple psychotropic medications even though there is not much information on how well these medications work together or if they are safe to administer together. Many youth with ADHD have co-occurring (comorbid) disorders such as oppositional-defiant disorder, anxiety disorders, and mood disorders. There is much interest in the treatment of children and adolescents with comorbid ADHD and anxiety disorders because this is a common condition in clinical practice. In addition, these children may have special needs because their anxiety may not improve when the ADHD is treated. SSRI medications represent a reasonable addition to stimulant treatment, as they are considered effective for anxiety disorders based on controlled trials in adults and open trials in children. However, there are no data from controlled studies regarding the tolerability and dosing of the combination of methylphenidate and SSRIs in the treatment of children with comorbid ADHD and anxiety disorder.

Methylphenidate is approved by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in children age 6 and older, and fluvoxamine is approved for the treatment of obsessive-compulsive disorder in adults and in children age 8 and older. This study will look at the combination of medication treatments for children and adolescents who are diagnosed with both ADHD and at least one of three anxiety disorders: Separation Anxiety Disorder, Generalized Anxiety Disorder, and Social Phobia.

Children with ADHD are often characterized by inattentiveness, distractibility, restlessness, over activity, impulsiveness, uncooperativeness and disorganization both at home and in school. Children with Separation Anxiety Disorder resist being away from home and their parents. They worry that something bad may happen to the parents when they are separated. They may have trouble sleeping alone or being home alone. They may resist going to school or may have an unrealistic worry about not being picked up after school. Children with Social Phobia are excessively worried about acting in a manner that might be embarrassing. They easily feel embarrassed and consequently are shy and quiet in many, though not all, situations. They are uncomfortable doing things in front of the class and may try to avoid eating in public or using public bathrooms due to fear of embarrassment. They may avoid parties or talking to unfamiliar people.

Children with Generalized Anxiety Disorder have frequent periods of worry that are upsetting and may interfere with their ability to function. They are often overly concerned about their performance at school. They often hold themselves to very high standards and then worry they cannot meet those standards. These worries may extend to worries about their performance in sports, their health, punctuality or catastrophic events such as natural disasters or wars.

In this study, children and adolescents will be evaluated for the presence of both ADHD and
Anxiety Disorder. Approximately 120 children and adolescents with both disorders who meet all the study entry requirements (such as being otherwise medically healthy) will first be treated openly with methylphenidate for 6 weeks. For those whose ADHD does not improve during this initial treatment period will not continue in the study but will be referred for further support in the community. Those who show improvement in both their ADHD and anxiety symptoms will stay on methylphenidate for an additional 8 weeks. Those who show improvement in ADHD but not anxiety will be asked to enter the double-blind phase of the study. In this phase, participants will be randomized (assigned by chance) to receive either fluvoxamine or placebo, in combination with methylphenidate, for 8 weeks. Those participants who are assigned to placebo and who do not show an improvement in anxiety after 8 weeks will be eligible for an additional 8 weeks of open treatment with fluvoxamine.

Enrollment in this study is expected to start in the spring of 2000. Four clinical sites across the U.S. are participating in this study. Weekly clinic visits will be required of all participants for the duration of the study (6 to 22 weeks, depending on response).

If you wish to have more information about this study, please contact one of the following sites:

Duke University Medical Center
Box 3431 Durham, NC 27710
Contact: Diane Johnson, Ph.D. 
Phone: (919) 416-2080
E-Mail: Johns211@mc.duke.edu

Kristan Jones
Study Coordinator
Duke Attention Deficit Program
(919)416-2124

Johns Hopkins School of Medicine
Child and Adolescent Psychiatry
600 N. Wolfe Street, CMSC 346
Baltimore, MD 21287
Principal Investigator: John Walkup, MD
Contact: Hyung Koo
Phone: (410) 614-4001
E-mail: hkoo@jhmi.jhu.edu

New York State Psychiatric Institute
1051 Riverside Drive
New York, NY 10032
Contact: Amy Zidel, M.A.
Phone: (212)-543-5676
E-Mail: Zidela@child.cpmc.columbia.edu

New York University Child Study Center
577 First Ave. New York, New York 10016
Contact: Suzanne Meehan
Phone: (212) 263-7779
E-mail: Meehas01@endeavor.med.nyu.edu
or Pat Rentas (212) 263-8679

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ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Does your preschool child have problems:

  • SITTING STILL

  • PAYING ATTENTION,

  • WAITING HIS/HER TURN?

Does your child have BEHAVIOR problems at home and in his/her preschool setting?

If these problems describe your child, he/she may be eligible for free treatment in a study for ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

The treatment involves 10 parenting classes on behavior management followed by a medication trial, if necessary

If your child is between the ages of 3 (36 months) and 5 ½ (66 months),

Please contact the Attention Deficit Disorder Program at

Duke University Medical Center
for more information 
Missy Willis
Study Coordinator
(919) 416-2092

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Addicted to Crack Cocaine?  

The Cognitive Behavioral Research and Treatment Program at Duke University Medical Center offers a free behavioral treatment for adults addicted to crack cocaine.

Eligible individuals can receive six months of weekly drug counseling, during which virtual reality and cell phones will be used as therapeutic tools to improve counseling results. Participants are compensated for completing evaluations, attending appointments and answering cell phone calls.

For more information, contact Naweah Attia at  919-684-6701 or naweah.attia@duke.edu 

 

(REF# 6314)

 

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ADULT ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

For more information visit:

http://www2.mc.duke.edu/adhdprogram/

 

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Menstrual Pain

Are You Suffering from Severe Premenstrual Symptoms?

A six-month antidepressant research treatment study for women suffering from severe premenstrual symptoms is underway at Duke. Participants will receive:

  • Evaluation by Board-Certified OB/GYN,
  • Psychiatrist, or Psychologist
  • Physical exam and laboratory evaluation
  • Study medication.

To qualify, participants must:

  • Meet Severe premenstrual symptoms criteria after psychological screening
  • Have regular ovulatory menstrual cycles
  • Be between 18 and 45 years old
  • Not be using medications for the treatment of pre-menstrual symptoms, including herbal treatments, antidepressants, or birth control pills.

For more information, contact Dr. Anna Stout and Dr. Diana Dell, at (919) 668-2570

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Having Trouble Sleeping with Chronic Fatigue Syndrome (CFS)?

If you are between the ages of 21 and 65, and have both CFS and trouble falling or staying asleep at night, you may be eligible to participate in a research study at the Duke Insomnia and Sleep Research Program. Eligible participants will learn new strategies to improve sleep.  

For more information, call Jackie Jones-Alexander at (919) 684-8385

Email: j.jones-alexander@duke.edu 

IRB # 00002157

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IS YOUR CHILD PAINFULLY SHY?

Does he or she avoid speaking in class, going to parties, or conversations with most people? If so, your child may be suffering from a condition known as "social phobia." Social Phobia is an anxiety disorder characterized by extreme fear and avoidance of social situations.

We may be able to help. At the Duke University Program in Child and Adolescent Anxiety Disorders Clinic, we can determine if your child needs help. He or she may also qualify to participate in a research project and receive FREE EXPERT CARE with medication. 

If your child is between the ages of 12 and 17, please call Study Coordinator, Vicki Brown at (919) 668-5147

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Posttraumatic Stress Disorder (PTSD)

Does your child experience any of the following as a result of a traumatic event?

  • Difficulty falling asleep or staying asleep

  • Irritability or outbursts of anger

  • Difficulty concentrating

  • Recurrent recollections of the traumatic event

  • Recurrent dreams of the traumatic event

 These symptoms may signal

If these behaviors describe your child, he or she may be eligible for free treatment with an Investigational medication.
For more information, please contact
Carolyn Cofrancesco, Study Coordinator
Duke University Medical Center (919) 416-2440

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Depression Interview

This is a study which is designed to evaluate the validity of a new screening tool for depression.  The study consists of a single visit of approximately 2 hours duration in which subjects complete some self-rating scales and undergo a structured interview designed to evaluate the presence and severity of symptoms of depression such as low mood, loss of interest, fatigue, sleep or appetite changes, and difficulties with concentration.  Participants will receive $15 compensation and a free parking pass.  All patients will be given feedback regarding whether they may be suffering from clinical depression.

For more information call Mae Burks at (919) 668-2572.

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VASCULAR DEPRESSION STUDY

This is a 3-month examining biological aspects of depression in adults aged 60 and older.

Purpose of study:  Certain cardiovascular conditions (e.g. hypertension, high cholesterol, diabetes, obesity, heart disease) can restrict blood flow to the brain, causing changes which are only apparent on a brain MRI scan.  We believe these brain changes are associated with an increased risk of depression ("vascular depression") and possibly pooer treatment response to currently available antidepressant medications.  In this study we will compare the effectiveness of antidepressant treatment in patients both with and without these vascular changes observed on the MRI.

Description of studyAll participants will receive open-label treatment with Zoloft - an approved antidepressant medication - for 3 months.  All participants will also get a brain MRI scan and cognitive testing.  Patients will meet with the study psychiatrist every 2 weeks during the study to monitor their response to the Zoloft.  There is no cost to subjects for participation.

Eligible patients will be:

  • 60+ andsuffering from major depression (Bipolar disorder is excluded)

  • with or without vascular risk factors or cardiovascular disease

  • able to get an MRI scan

  • willing to come off of any current antidepressant in order to start Zoloft

  • Free of any major neurological conditions such as dementia, Parkinson's disease, multiple sclerosis, or history of stroke

For information call Cammie Hellegers at (919) 681-3986
Email helle003@mc.duke.edu

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Aging & Memory Study

The Department of Radiology and Psychiatry at Duke University Medical Center are conducting a research study of older adults with memory difficulties.  The study is funded by the National Institutes of Health.

We seek men and women ages 55 to 85 who are experiencing all of the following:

  • trouble recalling names or words

  • trouble remembering recent events

  • short-term memory has worsened over past 6-12 months

  • memory decline noticeable to others

Eligible participants will be compensated between $40-$800 and will receive free memory testing and an MRI scan.  If interested, please call 681-3998.

IRB#1958

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Can Cholesterol Lowering Drugs 
Help Slow Alzheimer's Disease?

         Give us a hand in finding out.

Cholesterol lowering drus (also called "statins") are effective weapons in the fight against heart disease.  Now, some evidence suggests that statins also may be able to slow the devastating effects of Alzheimer's disease (AD) on the brain.

The Alzheimer's Disease Cooperative Study, a group of research centers sponsored by the U.S. Government's National Institute on Aging, is launching the CLASP-AD (Cholesterol Lowering Agent to Slow Progression of AD) research study to find out more about the effect on AD of one statin, called simvastatin (Zocor).

The CLASP-AD study is looking for volunteers who:

  • have mild to moderate AD
  • are age 50 or older
  • speak English
  • do not currently take or need cholesterol lowering drugs
  • have a study partner - a friend or relative who can accompany the volunteer to all clinic visits and answer questions about him/her.

CLASP-AD is a randomized, placebo-controlled research study.  Half of participants will be assigned at random to receive the experimental drug, the other half will receive placebo (inactive pill).  Participants will be assessed regularly by physicians and qualified health care professionals during the 15-month study.

For more information, or to volunteer, contact:
Lisalynn Kelley at Duke University Medical Center
at (919) 681-6605


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        Aripiprazole and Lamotrigine in Bipolar Disorder

Are you suffering from Bipolar Disorder, also known as Manic Depressive Disorder?

 If you are, you may be eligible to participate in a research study at Duke University Medical Center, where doctors are testing the safety and effectiveness of an investigational drug to treat the symptoms of depression in Bipolar subjects.  You will receive study drug and psychiatric evaluations, and can be compensated up to $800 for your time and expenses. 

For more information, please call Neena at 919-684-2873

IRB# 8767


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