How to Become Part of a Depression Drug Clinical Trial

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When new drugs are developed, there must be a series of clinical studies judging the safety and efficacy of the new drug. These trials are monitored by the FDA. There is a continuing need for participants in clinical trials testing new treatments for depression.

The qualifications to participate in a trial are strict, as are the rules for participation. This ensures reliable findings, on which major decisions will be made perhaps affecting many millions of lives and many millions of dollars.

Types of Trials

There are a number of types of trials taking place all the time.

Treatment trials test new drugs, new combinations of drugs, new treatment approaches, new devices or new surgical procedures.

Prevention trials look at ways of preventing the onset of a specific disease.

Diagnostic trials look for better ways to diagnose diseases or other health conditions.

Quality of life trials look at ways to improve quality of life for those suffering from chronic conditions.

Medication Trials

Clinical trials of medications have four phases.

The first trial, Phase I, is generally the smallest. The drug is administered to a small group of people (20 to 80) to determine the safety of the medication taken, a safe dosage range and to identify any side effects encountered.

Phase II has the drug administered to a larger group of people, to check further for safety and side effects.

Phase III is a large study, including thousands of people. The participants in this study suffer from the disorder being treated. The results of this study include effectiveness, side effects, comparisons of the effectiveness of the tested drug against existing drugs, and any other information that will inform the decision on the safe use of this drug. Successful outcomes from this phase generally lead to FDA approval.

Phase IV takes place after marketing of the new drug has begun. It continues to review safety issues, benefits to the use of the drug and the optimal dosage of the drug.

How to Find a Trial

There are many websites that list ongoing trials, or trials for specific diseases. The federal government (ClinicalTrials.gov), large medical centers, research facilities and physicians' groups all seek participants in trials. NIMH has a webpage devoted to current trials seeking participants suffering from depression, anxiety and a number of other disorders.

When considering a trial it is important to understand clearly what is expected of you, as well as what you can expect from the trial. Many trials pay a stipend ("inconvenience fee") and some pay the costs of travel to the location of the trial.

Not everyone will receive the drug or treatment under consideration. Often participants receive a placebo so that results can be compared. Not everyone will be accepted to the trial they want. Health issues, or sometimes lack of health issues, might disqualify your application.

Sources: ClinicalTrials.gov , Columbia Surgery and National Institutes for Mental Health

 
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