Campral Study for Anxiety

For This study, we are looking for subjects who

1. suffer from Social, Panic, Post Traumatic, 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 8 weeks we would like to add the drug, Campral(acamprosate), to your current medication regimen

BACKGROUND/PURPOSE:

You are being invited to take part in an experimental medical research study to learn if a drug called Acamprosate (Campral) is safe and effective for treating your anxiety symptoms while you continue to take your prescribed medication. Acamprosate has been approved by the U.S. Food and Drug Administration, (FDA) to treat alcohol abuse, (specifically it is indicated for the maintenance of abstinence from alcohol in those who are not drinking when beginning medication). This study is considered to be experimental because acamprosate 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.

The purpose of the study is to find the effect of Acamprosate when used in combination with an SSRI or SNRI ( types of antidepressants) in treating your anxiety symptoms that were not relieved while taking your current medication alone.

You have been asked to participate in this study because you have a current diagnosis of anxiety, as defined by standard medical criteria, and you are on an SSRI or 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.

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 8 weeks. This study is being funded by Forest Laboratories, (the manufacturer of Acamprosate).

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 8 study visits, and each visit will take approximately 1/2 - 2 hours. Following the study treatment period or at early termination, acamprosate may be 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 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 assessment of your medical and psychiatric history, review of your prior medications, urine test for pregnancy for women of childbearing potential, a physical examination (including weight, blood pressure, temperature, pulse, and respirations, heart, lung and neurological exams). You will be given several interview questionnaires about anxiety, depression and social well being. After the screening, and if you meet all the requirements, you will be entered into the study. You will also be given a prescription for the study drug Acamprosate. You will be asked not to start taking the drug until you here from us. We will need to verify the results of your urine test before you can start actually taking the Acamprosate. Subjects will begin acamprosate treatment in addition to their primary SSRI drug by taking two acamprosate (333mg) tablets, three times a day for the duration of the study. At the discretion of the investigator the dosage may be increased or decreased for an optimal response and tolerability. You will then be asked to return to the clinic for visit 2, 1 week 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 Acamprosate since the last visit, the study doctor may change the amount of Acamprosate you are taking. Between each visit, depending on how you are tolerating the Acamprosate and how it is affecting your symptoms, the amount you are taking may be increased or decreased. Any changes in how much Acamprosate you take will be done only after discussing it with your study physician. You will be asked to return in two week intervals following visit 2.

Visit 3 (week 4), and Visit 4, (week 6)

After reviewing your response to Acamprosate since the last visit, the study doctor may change the amount of Acamprosate you are taking. Any changes in how much Acamprosate you take will be done only after discussing it with your study physician.

Visit 5, (week 8)

You have been treated for 8 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 in 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 Acamprosate may include diarrhea, headache, abdominal pain, vomiting, constipation, drowsiness, muscular tenderness, and joint pain. Other side effects include: palpitation, (a perceptible, forcible, pulsation of the heart), swelling, weight gain, rash, vision change and sexual dysfunction. If any of these occur, notify your study doctor immediately.

Not all potential side effects of Acamprosate are known at this time. It is possible that other, more serious unknown side effects may occur. Also, there is the possibility of other side effects when adding acamprosate with your current SSRI or SNRI.

Taking Acamprosate 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.

A urine pregnancy test for women of childbearing ability will be performed prior to study enrollment and at the week 8/early termination visit (visit 5) and at any time pregnancy is suspected. Any woman who finds that she has become pregnant while taking part in the study should tell her study doctor right away.

The study treatment may have no positive effect for you, or you may feel a worsening of your anxiety.

POTENTIAL BENEFITS:

We hope that this acamprosate treatment will help you. However, that you will receive direct benefit from participating in this research study cannot be guaranteed. The information we get 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 suffer an adverse event during this study, the study clinicians will do their best to alleviate that side effect. If side effects cannot be alleviated without stopping Acamprosate, you maybe withdrawn from the study. You may also be dropped from the study for non-compliance with the study rules. The study clinicians will still meet with you to ensure your side effects resolve.

You will be told of any significant new information regarding Acamprosate which may affect your willingness to take part in the study. Also, on receiving new information your study doctor might consider it to be in your best interest to take you out of the study. He/she will explain the reasons for the need for your withdraw.

ALTERNATIVES:

Other possible treatment choices do exist for you outside of this study. This includes both 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 Acamprosate outside of the study.

COSTS/PAYMENTS:

You and/or your insurance carrier will not be charged for the study visit or the actual study drug. You will be responsible for all travel and parking expenses. You will not be paid for your participation in this study.