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Would a Clinical Trial be Right for Me?
Sometimes, those with mood disorders may hear of a promising new drug still in clinical trials. These trials appeal to those who:
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feel they are good candidates because the drug company is targeting their very symptoms
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those who have annoying side effects from their current drugs and feel eager to find a different medication.
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do not respond to a variety of medications they try
Before you make any decisions, make sure you consult with a trusted doctor before signing on to a clinical trial.
How Do Clinical Trials Operate?
Government organizations, universities, non-profits and for-profit drug companies all work tirelessly to develop new, more effective drugs that have fewer side-effects. These entities usually win grants or funding and then, after obtaining good results with animal studies, recruit individuals to participate in trials. They find participants through doctors, radio and newspaper advertisements, all legitimate avenues. Some trials focus on medications; others on new forms of psychotherapy. Both follow structured, approved plans before the trial gets underway. Every new medication must be tested through clinical trails. After reviewing the results, the FDA (The Food and Drug Administration) either approves the drug for distribution or denies approval, sending it back to the lab for more tests.
Types of Clinical Trials
Some clinical trials have all participants take the experimental medication or undergo the experimental “talk therapy.” Other clinical trials split the participants into two groups: those who take the medication or experience therapy and those who take a “placebo” or “sugar pill” or refrain from therapy. Throughout the trial, researchers continually evaluate participants, not only taking their own notes and measurements, but asking whether the participant is experiencing any changes in mood or side-effects. Researchers may also need to execute laboratory tests, such as blood and urine tests.
Would a Clinical Trial Help Me?
It depends. There are several benefits to participating in a clinical trial, particularly if the drug targets your specific symptoms. First, you have access to a drug that is not widely available. Second, while participating in the trial, it’s most likely that you’ll interact with several specialists, gaining access to multiple opinions and extensive experience. Finally, the drug may have fewer side effects than the one you’re currently taking, as doctors continually work to eradicate these. Best of all, you get all this for free! The study organizers typically don’t charge for medications, visits or tests.
If you’re concerned about safety and convenience, rest assured that clinical trials have evolved significantly in the past two decades. With the proliferation of lawsuits, the testing institution, doctors, therapists and nurses now carefully protect the rights and well-being of research volunteers.
That said, make sure that, when considering participating in a clinical trial, you center your decision on your own personal needs, interests, beliefs and expectations. Do not undergo any therapy to please family members, doctors or anyone else in your life. It’s important that you research the trial thoroughly and read all agreements you’re asked to sign. You have a responsibility to know all risks involved before agreeing.
What About the Downside?
Every choice we make in life includes risks. Receiving a diagnosis of bipolar disorder means you’re at higher risk for certain negative events. But some risks can be avoided. If after exploring a clinical trial you do not see any benefit to you, think again about participating. Some negatives of being involved in a clinical trial include:
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you may be requested to stop taking a current medication
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you may be given the “placebo” rather than the potent medication
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the side-effects of the drug under study may effect you adversely
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participating in the trial doesn’t guarantee you’ll receive the new medication once the trial concludes your illness is not the center of the doctor’s focus. The trial and overall research is. In clinical trials, the research comes first and the patient, second. Your doctor and other healthcare professionals do focus on you and your illness. Make sure to consult with them before you agree to be a research subject.
Could My Participation Be Turned Down by Researchers?
Yes. Because clinical trials measure very specific symptoms and responses, researchers establish strict criteria for participation. Do not ever take being turned down personally. Researchers may screen for individuals:
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with a diagnosis of the illness the medication has been designed to treat
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who even display the subtype of the illness (clinical depression rather than dysthymia, for example) and specific symptoms (like rapid cycling)
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who are free of other illnesses the treatment of which may skew the results of the treatment to be studied
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who do not take any other medication
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who do not drink to excess or take “street” drugs
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who have never taken the medication to be studied
Is Hospitalization Necessary?
No. Researchers typically conduct clinical trials for mood disorders on an outpatient basis. The only times a clinical trial takes place in a hospital is when the study requires already hospitalized subjects.
What Does “Informed Consent” Mean?
Once accepted as a volunteer, researchers will ask you to sign an “informed consent” form. Even if a trusted doctor or friend has recommended this trial for you, make sure you take your time reviewing it yourself. You do not need to sign the form right away. Share it with family members and friends. It may be wise to have others agree to intervene should your symptoms or side effects become unmanageably severe during the trial.
The informed consent form describes how the trial will proceed. It also covers the testing procedures and different treatment possibilities. It’s important that you closely examine the potential benefits and risks of the treatments to be studied, along with any hazards or discomforts that can arise. Share these with friends or family members, preparing them for possible behavior changes. Should you become unable to make competent decisions, they will need to intervene.
How Can I Find Out About Clinical Trials?
A trusted mental health professional with whom you have a relationship should be your first resource. He or she understands your illness and your other medical issues well.
Institutions and other organizers advertise their trials through the advertisements on the radio, in the newspaper and on television. These trials are more common in cities and even college towns than in rural areas.
The Office of Public Inquiries at the National Institute of Mental Health (NIMH) lists current clinical trials involving mood disorder treatments at www.nimh.nih.gov. Click on the “Clinical Trials” link. You can also call them at (301) 443-4513, fax them at (301) 443-4279 or email them at nimhinfo@nih.gov. Their address is NIMH Public Inquiries, 6001 Executive Boulevard, Room 818, MSC 9663, Bethseda, MD 20892-9663.
Some trials are also listed on www.centerwatch.com.
Before Signing On . . .
Below is a checklist of all trial information you should have before agreeing to volunteer. It will help you make sense of the clinical trial materials. Look through the consent form and any study materials provided by the researchers to find the answers to the following questions. Print these pages, and store them in a safe place once completed. Let a friend, family member or healthcare provider know where they’re stored.
Facts About the Trial
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? The trial is studying: ______________________________________________
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? The trial’s goal is: ________________________________________________
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? The trial will last: ________________________________________________
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? The trial is funded by: ____________________________________________
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? Research will take place: __________________________________________
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? Study coordinators can be contacted at: ______________________________
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? Study methods include: ___________________________________________
_______________________________________________________________ _______________________________________________________________ _______________________________________________________________Costs and Logistics
I will need to get:
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? Where: ________________________________________________________
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? When: _________________________________________________________
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? How often: _____________________________________________________
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? Length of appointment: ___________________________________________
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? My transportation service will be: ___________________________________
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? My transportation will be paid by: __________________________________
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? I am obligated to pay: _____________________________________________
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? This payment is due: ______________________________________________
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? I will be paid: ___________________________________________________
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? I will receive payment: ____________________________________________
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? Available Childcare Name/Phone: ___________________________________
Treatment Facts
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? My chance of receiving actual treatment: _______________________________
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? My chance of receiving actual placebo: ________________________________
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? I will/will not be able to use the new treatment after the trial: _______________
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? The new treatment will be available for me (date): _______________________
Disclosure & Privacy Issues
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? My confidentiality and privacy will be protected with ____________________ ________________________________________________________________
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? Should negative findings about my mood disorder arise, only the following people/institutions will be informed: __________________________________ ________________________________________________________________
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? I can drop out of the trial by taking the following steps: __________________________________________________________________ __________________________________________________________________ __________________________________________________________________
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? If I am injured during the trial, I need to contact: __________________________________________________________________ __________________________________________________________________
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? If I am injured during the trial, I am entitled to: __________________________________________________________________ __________________________________________________________________
Preparations: Medication
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? My current medications: ____________________________________________
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? Medications I can continue through the trial: ____________________________
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? Medications I must discontinue: ______________________________________
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? Date I must discontinue medication: ___________________________________
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? Date I can resume medication: _______________________________________
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? Health risks involved with using both current medications and trial medication:
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? Side effects of trial medication: ______________________________________
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? Side effects of trial medication combined with current medication:
_______________________________________________________________
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? I will/will not be able to adjust trial medication dosage: ___________________
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? I will/will not be able to take a mood stabilizer: _________________________
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? Amount I can adjust dosage: ________________________________________
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? Risks of trial medication: _______________________________________
_______________________________________________________________ _______________________________________________________________ -
? Benefits of trial medication: _______________________________________ _______________________________________________________________ _______________________________________________________________
- ? If I experience severe side effects from the medication, I need to call: _______________________________________________________________
- ? If I experience severe side effects from the medication, I must also: _______________________________________________________________ _______________________________________________________________
Preparations: Illness
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? If I become ill and cannot attend my appointments, I need to call: _______________________________________________________________
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? If my mood disorder symptoms worsen, study personnel will be notified by: _______________________________________________________________
Glossary of Clinical Trial Terms
Control: adj. A treatment with either no potency or a pre-determined potency. Subjects in the control group receive either a standard, commonly used treatment or a placebo, also known as a sugar pill.
Crossover: adj, v. Describes a study where participants receive a random assignment to one or two or more treatment options for a certain length of time. Once the first time period ends, researchers assign volunteers to one of the remaining treatments. Volunteers “crossover” treatments.
Doubleblind: adj. Describes a study where neither the participants nor the researchers have been told which group has received the treatment under study and which the placebo.
Informed Consent: n. The forms a participant signs to agree to the terms and conditions of the trial. Includes a statement acknowledging the participant understands and accepts the trial’s procedures as well as its risks.
Institutional Review Board (IRB): n. Scientists and others assigned to oversee the design of a clinical trial. The IRB also periodically reviews ongoing research to monitor any potential breach in ethics or divergence from the initial protocols.
Placebo: n., adj. A pill or treatment chosen to have no impact on the research subject. Also called a “sugar pill.”
Placebo Effect: n. An outcome where the subject receiving a “sugar pill” or placebo experiences an improvement in condition or symptoms, despite the fact that the treatment is known to be impotent.
Protocol: n. The rules and procedures that designers of the study have established and must follow. Because the trial’s scientific accuracy depends on adherence to theseprocedures, deviating from them is not permitted. Therefore, subjects must be comfortable with all constraints before beginning.
Randomized: adj. A clinical trial where participants are placed into groups by chance rather than direct assignment based on any characteristics.
Single-blind: adj. A type of study where researchers know which participants have been placed in the placebo group and which in the experimental treatment group.