| Adjunctive Therapy:
Subjects are given study medication, in addition to medications
they are already taking.
Blinded study: A study done
in such a way that the patients or subjects do not know (is
blinded as to) what treatment they are receiving to ensure that
the results are not affected by a placebo effect (the power
of suggestion).
Chemical dependence: The habit
of using alcohol or drugs; usually separated from “substance
abuse” or “addiction,” in which the habit
is more severe.
Clinical Trial: A controlled
study involving human subjects, designed to evaluate prospectively
the safety and effectiveness of new drugs or devices or of behavioral
interventions.
Confidentiality: A promise
from the interviewer to the person being interviewed that no
information will be given to anyone except the researchers if
it can show who the person being interviewed is.
Control Group: In a test or
trial, a group that does not receive the new treatment being
studied and which is compared to the group that does receive
the new treatment.
Diagnosis: A name of an illness
and a description of the illness; usually taken from the “Diagnostic
and Statistical Manual” of the American Psychiatric Association,
which tries to group clients by their symptoms and the course
of their illness.
Double-Blinded
Study: Neither the study participants nor the study
professionals know which participants are receiving the test
therapy and which participants are receiving standard therapy
or placebo.
Dual diagnosis: Two different
“diagnoses” given to the same person. This term
is used most often for a “severe” mental illness
combined with some form of “chemical dependency”
(for example, schizophrenia combined with dependence on marijuana).
Exclusion Criteria: When a
subject does not meet the basic parameters for participation
within the study because she/she doesn't have a certain characteristic
or trait, they may be excluded from the sample.
Experimental Group: A group
that does receive the new treatment being studied.
Fixed Dosage: All subjects
are given the same dose of medication throughout the study.
Informed consent: Agreement
of a person being studied, based on the person’s knowledge
about the goals, methods, benefits, and risks of the study.
Informed consent is given with the understanding that the person
can change his or her mind about the study at any time.
Institutional Review Board (IRB):
An IRB is an independent committee of physicians, nurses, pharmacists,
scientists, ethicists, and community advocates. Every clinical
trial conducted in the United States requires IRB approval and
monitoring to protect each participant's rights and welfare.
Mood Disorder: A disorder in which a person’s emotional mood is distorted or inappropriate to the situation. The two major mood disorders are depression and bipolar disorder.
Mood Stabilizer: A psychiatric
medication used to treat mood disorders, including bipolar disorder.
Mood stabilizers include: depakote, lithium, and lamictal.
National Institutes of Mental Health
(NIMH): A federal institution for research (especially
biomedical research) related to causes and treatments of mental
illness.
Open-label: Known active study
medication taken during a clinical trial.
Phase: Clinical trials of experimental
drugs progress through four phases:
In Phase I clinical trials, researchers
test a new drug or therapy in a small group of participants
(20-80) for the first time to evaluate treatment safety, determine
proper dosage, and observe side effects.
In Phase II clinical trials, researchers
administer the study drug or therapy to a larger group of participants
(100-300) to further evaluate both its safety and effectiveness.
In Phase III clinical trials, researchers
administer the study drug or therapy to large groups of participants
(1,000-3,000) to confirm effectiveness, identify risks, monitor
side effects, and compare and contrast study treatment safety
and effectiveness with commonly used therapies.
In Phase IV clinical trials, researchers
continue testing the study drug or therapy in order to measure
treatment effectiveness and monitor the effects of long-term
use.
Placebo:
A placebo is an inactive substance that holds no treatment value.
In clinical trials, the experimental therapy is often compared
to the placebo to measure treatment effectiveness.
Principal Investigator (PI):
The main person running a research study.
Privacy: Control over the extent,
timing, and circumstances of sharing oneself (physically, behaviorally,
or intellectually) with others.
Protocol: A protocol outlines
the specifics of the clinical trial, namely, study qualifications,
time points, treatments, and procedures.
Randomization: Assignment of
subjects to different treatments, interventions, or conditions
according to chance rather than systematically.
Research: A systematic investigation
designed to develop or contribute to generalizable knowledge.
Side Effects: Side effects
are any undesired actions or effects caused by the study drug
or therapy.
Voluntary: Free of coercion,
duress, or undue inducement. Used in the research context to
refer to a subject's decision to participate (or to continue
to participate) in a research activity.
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