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Depression and Anxiety Disorder Research Program

Namenda Study for Anxiety

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For This study, we are looking for subjects who

 

1.  suffer from Social or Generalized Anxiety who are taking one of the following: prozac, zoloft, paxil, lexapro, celexa, effexor, or cymbalta

2.  despite taking the above medication, anxiety continues to be a problem

3.  You must NOT also suffer from major depression, bipolar disorder, schizophrenia or substance misuse.

 

IF YOU FEEL YOU FIT THIS PROFILE AND WOULD LIKE TO LEARN MORE, PLEASE CONTACT US

 

 

STUDY DESCRIPTION BELOW

 

For 10 weeks we would like to add the drug, Namenda (memantine), to your current medication regimen

           

 

BACKGROUND/PURPOSE: 

 

You have been asked to participate in a research study because you have a current diagnosis of general anxiety or social anxiety, as defined by standard medical criteria, and you are on an SSRI or an SNRI and despite this, you are still having symptoms associated with your anxiety. In order for you to participate in this study, you must be able to speak English, be between the ages of 18 and 64 years, and be in stable health.  You must also be able to understand and complete rating scales and questionnaires related to your anxiety.

 

The purpose of this experimental medical research study is to learn if a drug called Memantine (Namenda), is safe for treating anxiety symptoms in individuals who take their prescribed medication.  Memantine has been approved by the U.S. Food and Drug Administration, (FDA) to help slow down the progression of alzheimer’s dementia. The use of Memantine is considered to be experimental in this study because Memantine has not been FDA-approved to treat the symptoms associated with anxiety.

 

Before you decide to participate, it is important for you to understand why the research is being done and what it will involve.  Please ask if there is anything that is not clear or that you would like more information. Please ask questions regarding the study, what will be done, or procedures you may undergo. Take time to decide whether or not you wish to take part.

 

This study hopes to learn about the effect of Memantine when used in combination with an SSRI (a type of antidepressant: such as fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), citalopram (Celexa), escitalopram (Lexapro)), or an SNRI (such as venlafaxine XR) in treating anxiety symptoms that are not relieved while taking current medication alone.

 

 

There will be approximately 15 people participating in this study. The total duration of your participation in the study will be for approximately 10 hours scattered over 10 weeks.

 

 

 

STUDY PROCEDURES:

 

If you agree to participate, you will continue to take your usual physician prescribed SSRI or SNRI in the same dosage, frequency and formulation throughout the course of the study. We will ask you not to change this medication if at all possible.  You will be asked to come to the office for 4 study visits, and each visit will take approximately 1/2 - 2 hours.  Following the study treatment period or at early termination, memantine may be prescribed by your private physician or  will be tapered over a 2 week period.

 

It is very important to avoid becoming pregnant while you are taking part in this study and for 30 days after your participation is completed.  During this study you must continue to use a medically acceptable and effective method of birth control that you have been using for a minimum of three months and will continue to use for one month after the study is over.  

 

Visit 1 (screening/baseline visit, (week 1)

Before entering the study, you will be evaluated (or screened) by the study doctor to make sure you meet all the requirements to enter the study. This includes reviewing of your medical and psychiatric history, review of your prior medications, a urine test for pregnancy for women of childbearing potential, and a physical examination (including weight, blood pressure, temperature, pulse, and respirations, heart, lung and neurological exams).  You will be given several interview questionnaires to complete about anxiety and social well being.

 

After the screening, and if you meet all the study requirements, you will be entered into the study.  You will be asked not to start taking the study drug until you here from us. We will need to verify the results of your pregnancy test before you can start taking the memantine. You will begin memantine treatment in addition to your primary SSRI or SNRI medication. You will take 5mg per day of memantine. This dose may be increased to get the best results, and depending on how well you react to the study drug. The most you will take is 20mg/day. You will then be asked to return to the clinic for visit 2, 2 weeks later.

 

Visit 2, (week 2)

Your blood pressure, temperature and pulse will be monitored. You will be asked a similar number of questions to assess your progress and be asked to complete questionnaires that relate to how you are feeling and how you view your progress.

 

 After reviewing your response to Memantine since the last visit, the study doctor may change the amount of Memantine you are taking. Between each visit, depending on how you are tolerating the Memantine, and how it is affecting your symptoms, the amount you are taking may be increased or decreased. Any changes in how much Memantine you take will be done only after discussing it with your study physician.  You will also be given a new supply of memantine to last until your next visit. You will then be asked to return to the clinic for visit 3, 2 weeks later.

 

 

Visit 3 (week 4)

 

Your blood pressure, temperature and pulse will be monitored. You will be asked a similar number of questions to assess your progress and be asked to complete questionnaires that relate to how you are feeling and how you view your progress.

 

 After reviewing your response to Memantine since the last visit, the study doctor may change the amount of Memantine you are taking. Any changes in how much Memantine you take will be done only after discussing it with your study physician.  You will also be given a new supply of memantine to last until your next visit. You will then be asked to return to the clinic for visit 4, 6 weeks later.

 

 

 

Visit 4, (week 10, or early termination)

You have been treated for 10 weeks and this is your final visit of the study. This visit is similar to your screening visit. You will be asked a similar number of questions to assess your progress and be asked to complete questionnaires that relate to how you are feeling and how you view your progress. You will also have another physical exam as you did at the screening visit, including a urine pregnanacy test if you are a  women of childbearing potential.

 

 POTENTIAL RISKS:

 

Commonly observed side effects associated with the use of Memantine may include: headache, dizziness, constipation, and rash. If any of these occur, notify Dr. Schwartz immediately.

Taking Memantine during pregnancy may expose the fetus to unknown risks, including the possibility of birth defects. Pregnant women must not take part in this study; neither should women who plan to become pregnant during the study, or women who are currently nursing a baby.  Namenda caused damage to nerve cells in the brains of rats at doses higher than those you will receive, the significance of this finding to humans is unknown.

 

A urine pregnancy test for women of childbearing potential will be performed at the screening visit and at the week 10/early termination visit (visit 4) and at any time pregnancy is suspected. Any woman who finds that she has become pregnant while taking part in the study should tell Dr. Schwartz right away.

 

The study treatment may not help your anxiety symptoms, or you may feel a worsening of your anxiety symptoms.

 

 

POTENTIAL BENEFITS:

 

We hope that memantine treatment will help you. However, that you will receive direct benefit from participating in this research study cannot be guaranteed. The information we learn from this study may help us to treat patients with anxiety better in the future.

 

 

VOLUNTARY PARTICIPATION/STUDY WITHDRAWAL:

 

Your participation in this study is entirely voluntary and you may refuse to participate or discontinue participation at any time without penalty or loss of benefits to which you would normally be entitled.  Your decision about whether or not to participate in the study will not affect the care you receive at SUNY Upstate Medical University. 

 

If you have side effects during this study, the study doctors will do their best to alleviate that side effect.  If side effects cannot be alleviated without stopping Memantine, you maybe withdrawn from the study. You may also be withdrawn from the study for if you are not able to follow the study procedures. The study doctors will still meet with you to ensure your side effects resolve.

 

You will be told of any significant new information regarding Memantine which may affect your willingness to continue to take part in the study.  On receiving new information the study doctor might consider it to be in your best interest to take you out of the study. The study doctor will explain the reasons for the need for your withdrawal.

 

 

ALTERNATIVES:

 

Other possible treatment choices do exist for you outside of this study.  This includes both the addition of sedatives or changing to a different SSRI  or SNRI agent.  You may ask your private physician about these options, including the use of Memantine outside of the study. 

 

 COSTS/PAYMENTS:

 

You and/or your insurance carrier will not be charged for any part of this study, The study drug will be provided free of charge by Forest Pharmacueticals, (the company that makes Memantine). You will be responsible for all travel expenses and parking fees related to this study.

You will not be paid for your participation in this study.

 

 

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