FDA Black-Box Warning
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [this drug] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality...
FDA Black-Box Warning
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [this drug] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
Despite widespread use of antidepressants to treat minor depression, a recent, thorough review has found that there is no advantage to treating this condition with these drugs.
However, antidepressants are effective for treating major depression, although patients still should be aware of dangers associated with the drugs. Following a discussion of major depression, there will be a discussion of minor depression and the results of the recent study will follow.
A major depressive episode: the kind that will usually respond to drugs
If a depressed mood or a loss of interest in activities is accompanied by at least four of the following seven problems, has been present for at least several weeks, and a careful history, physical exam, and lab tests have ruled out specific, secondary causes of depression, true primary (major) depression is probably the diagnosis. The seven problems are:
- difficulty concentrating,
- low self-esteem,
- suicidal thoughts,
- extreme fatigue,
- low energy level or agitation, sleep disturbances (increased or decreased), and
- appetite disturbance (increased or decreased) with associated weight change.
Another way of describing the pervasive nature of this kind of severe depression is that the person displays — and relates, if asked — a sense of “helplessness, hopelessness, worthlessness and uselessness ... as well as intense feelings of guilt over real or imagined shortcomings or indiscretions,” according to psychiatrist Carl Salzman.
Because suicidal thoughts and attempts often characterize depression, the possibility of suicide using antidepressant drugs has to be kept in mind and only a small number of pills prescribed at one time. Recent studies have shown that the use of these drugs can worsen the depression in some fraction of patients less than 24 years of age and the black-box warning shown at the beginning of this article is now included on the drug labels.
Much controversy, however, has surrounded the effectiveness of antidepressant drugs in what is referred to as minor depression.
Symptoms of minor depression can include poor school or work performance, social withdrawal, shyness, irritable hostility, conflicts with family and friends, and sleep irregularities. Some of the symptoms may be the same as those listed for major depression, but there are not as many and the duration may be shorter.
One kind of minor depression — called situational depression or reactive depression, which should not be treated with antidepressant drugs — involves normal, understandable reactions to life problems, such as the loss of a spouse, friend, relative or job, or other situations that normally make almost anyone sad. If the depression is clearly a response to overwhelming life crises, antidepressants have little value. Other options, such as support from family and friends, psychotherapy with a mental health professional or a change in environment, are worth exploring. Doing something nice for yourself, talking with a friend and exercising every day can help you get through these difficult situations.
A recent meticulous review published in the British Journal of Psychiatry examined all randomized, placebo-controlled studies in which an antidepressant was compared to a placebo to determine the effectiveness. The studies involved people 18 years or older, but studies were excluded from the analysis if they contained patients diagnosed as having major depression (see criteria). Among the studies were ones in which patients were randomized to receive either paroxetine (PAXIL), fluoxetine (PROZAC), amitriptyline (ELAVIL), or isocarboxazid (MARPLAN) or a placebo.
Only one of the above antidepressants was used in any individual study. The combined analysis of these studies failed to show any significant difference in terms of effectiveness in combating depression.
According to the authors of this study, the clinical implications were: “There is now a clear indication that psychological treatments for minor depression have a significant effect on depressive symptoms, at least in the short-term. This indication, together with the results of the present systematic review, may suggest that antidepressants should not be considered for the initial treatment of individuals with minor depression.”
What You Can Do
People who are taking antidepressants should never stop taking them without talking to their doctor, because stopping too quickly can cause side effects.