Clinical Trial on New Antidepressant Medication for Patients with Depression

Clinical Trial on New Antidepressant Medication for Patients with Depression

UPDATE: October-2012. This trial is no longer recruiting patients.

Despite numerous treatment options, major depression remains a widespread, debilitating illness. Two-thirds of patients who are initially prescribed antidepressant medications do not experience a timely response to their treatment.

This study is to evaluate the potential benefits of a brand-new drug (EB-1010) in the treatment of depression in patients who have failed an initial course of treatment with other drugs.

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Eligibility

• Men and women between 18 and 65 years old
• Diagnosed with depression
• Taking one (and only one) accepted antidepressant medication
• Antidepressant medication is not being very effective, you still experience depression symptoms
• Not having other psychiatric disorders, like bipolar, OCD, PTSD, anxiety, eating disorders, etc.

NOTE: This clinical trial is now also accepting patients who are not taking antidepressants at the moment, or who are not formally diagnosed. If you enter the study, you will be given antidepressant medication.

There are other factors that determine if you can take part in this trial. See the pre-screening test.

Study medication

EB-1010 is an investigational antidepressant that elevates the brain levels of three chemicals: serotonin, norepinephrine, and dopamine.

Scientists believe that elevating brain levels of dopamine as well may help depressed patients get better, and possibly avoid the troublesome side effects (eg: sexual problems, weight gain) that are associated with these type of medications.

EB-1010 has been given to over 200 healthy volunteers and to 100 patients with depression to date.

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Potential Benefits

Taking part in this study may improve your condition. However, there may be no direct benefit to you. The study will provide doctors with information about the study medication, which along additional studies may lead to approval of EB-1010 for use in depression.

Possible Risks

Some side-effects observed for EB-1010 were headache, feeling sleepy, feeling dizzy, nausea, and vomiting. Some people had skin rashes and body itch, so doctors will be specifically looking into this possible reaction.
Due to its new way of acting, EB-1010 may have less chances of causing sexual dysfunction (impotence, lack of sexual desire) and weight gain. However, this cannot be completely ruled out. The staff at the clinic will discuss all potential risks and side effect with you before you decide to take part in the study.

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Compensation

There is a $50-75 per visit allowance to compensate for travel and time for taking part in the study.

There will be no cost to you for the study medication, or the study related procedures and examinations.

Duration

Up to 13 weeks.

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Screening

• 2 to 4 weeks
• Physical examination
• Standard checks (e.g.: urine and blood samples)
• Complete some questionnaires about your depression and overall health status

Treatment

• You will be taking 4 pills x day (2 in the morning and 2 in the evening) of either study medication (EB-1010), or a placebo (sugar pill) or another antidepressant.
• Visit the clinic once a week (up to 15 visits in total). You are not required to spend the night at the clinic.
• During treatment, you must also:
   - Tell the study doctor about any health problems you have during the study
   - Do not take other drugs or remedies unless the study doctor has approved them beforehand
   - Take the study drug as instructed
   - Return unused study drug and all empty packages to your study doctor at each visit
   - Come to all visits on time
   - Do not participate in other medical research studies
   - Do not get pregnant
• The study doctor or nurse will explain you this in more detail before you decide to take part in the study.

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Sponsor

Euthymics Bioscience Inc., in collaboration with Harvard Clinical Research Institute (HCRI).

Confidentiality

• Staff at Harvard Clinical Research Institute, as well as other personnel from the clinic will know that you have taken part in the study.
• However, this information is confidential and your personal data will be coded - all records and other information about you will be identified by your initials and a subject number, not your full name.
• Your doctor will be notified of your participation in this study and asked if he/she knows of any reason why you shouldn't take part.

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Official title

Last Updated on July 25, 2014