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262 The APA Publishing Textbook of Mood Disorders, Second Edition
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cited earlier, no increase in actual suicides was found. The rates of new-onset suicidal
ideation were as follows: fluoxetine alone, 7.3%; CBT, 3.6%; combined treatment,
2.8%; and placebo, 2.7%. The rates of suicide attempts were as follows: fluoxetine
alone, 1.8%; CBT, 1%; combined treatment, 1.9%; and placebo, 0%. Finally, the rates of
all suicide-related events were as follows: fluoxetine alone, 9.2%; CBT, 4.5%; com
bined treatment, 4.7%; and placebo, 2.7%. These data certainly suggest that fluoxetine
increases the frequency of suicidal ideation and attempts, although not that of com
pleted suicide.
Two other interesting observations come from this study. First, combining fluoxetine with CBT reduces the rate of suicidal ideation, although not attempts. The observation of reduced suicidal ideation may be due to the fact that combined treatment
was more effective than either monotherapy condition; the response rates were as fol
lows: fluoxetine alone, 60.6%; CBT, 43.2%; combined treatment, 71.0%; and placebo,
34.8%. Second, CBT alone increased suicide-related events to a small degree, a finding
that may mean that any effective treatment may increase the likelihood of suicide
events in a small number of adolescents. The fact that all active treatments increased
suicidal ideation and self-injury argues for heightened vigilance in depressed adoles
cent patients.
A key question, then, is why is there an apparent excess at all? The TADS is informative in determining possible mediators of the increased risk for suicidal ideation and
behavior. Important side effects such as “mania spectrum,” “agitation spectrum,” and
anxiety were increased in patients treated with fluoxetine. These symptoms suggest
that the antidepressant may have been inducing a manic or mixed state that could have
led to an increase in agitation, anxiety, irritability, hostility, and suicidal preoccupation.
Second, antidepressants can induce anxiety and agitation in patients with depression
even in the absence of a bipolar diathesis, but with a similar outcome. Furthermore,
some medications such as paroxetine and venlafaxine have relatively short half-lives
and are known to induce withdrawal reactions. Missing one or more doses could result
in an abrupt return of depressive, anxious, and other symptoms, leading to suicidal
ideation. These kinds of factors together could contribute to an excess of suicidal ideation, suicide attempts, or self-injury in the TADS and FDA datasets.
Olfson et al. (2003) evaluated the relationship between the changes in regional antidepressant medication treatment and suicide in adolescents from 1990 to 2000, using
a large pharmacy database. They found that a 1% increase in frequency of prescription
of antidepressant drugs resulted in a decrease in suicide frequency of 0.23 per 100,000.
For the period of 1991–2001 in the United States, the suicide rate for children ages 10–
14 years showed a decline of approximately 14%, whereas the rate for 15- to 19-year
olds showed a decline of 31.5% (Centers for Disease Control and Prevention 2004).
The increase in frequency of antidepressant prescriptions over the same period sug
gested that these medications contributed to this decline. Similar results were shown
in subsequent studies (Gibbons et al. 2005; Grunebaum et al. 2004; Ludwig and Mar
cotte 2005).
The FDA and other regulatory agencies required all antidepressants to have a
“black box warning” about new-onset suicidal ideation or behavior starting in 2004.
Following this change, the rates of suicide among adolescents began to increase after
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263 Selective Serotonin Reuptake Inhibitors and Related Antidepressants
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more than a decade of decline (Bridge et al. 2008). In the period after the black box
warnings, the frequency of antidepressant medication prescriptions for adolescents
declined (Busch and Barry 2009), but the frequency of diagnosis of depression among
adolescents also declined (Adegbite-Adeniyi et al. 2012; Libby et al. 2007; Olfson et al.
2008). Although the frequency of prescribing antidepressants for adolescents has in
creased somewhat since that initial decline, the rate of suicide continues to increase,
particularly among girls (Curtin et al. 2016).
Drug-Drug Interactions
Although the newer antidepressants are generally safe drugs, they do confer risks for
serious drug-drug interactions under certain circumstances. Perhaps the most serious
is the combination of SSRIs and MAOIs, which can lead to the development of a po
tentially fatal “serotonin syndrome.” These drugs should never be taken in combination, and patients should not begin taking an MAOI for at least 2 weeks after
discontinuing an SSRI (for fluoxetine the washout period should be 4 weeks or longer).
Serotonin syndrome presents within 24 hours of initiating or increasing the dosage of
a serotonin agent and results from overstimulation of 5-HT
ceptors. It consists of a constellation of mental, autonomic, and neurological symptoms. The full-blown syndrome is diagnosed when a patient presents with at least four
major symptoms or at least three major and two minor symptoms. Major symptoms
include confusion, elevated mood, coma, fever, tremors, chills, and rigidity (among
others), and minor symptoms include agitation, insomnia, tachycardia, tachypnea,
and impaired coordination. Treatment always involves discontinuing the serotonergic
agent and replacing fluids.
A second way in which drug-drug interactions can occur is through competitive
protein binding. Antidepressants circulate in a state highly bound to proteins such as
albumin, and other drugs that circulate in a highly bound state can displace the antidepressants, resulting in an increase in the fraction of the drug that is unbound. This may
amplify the drug’s effects, particularly its side effects (see Table 15–1). Most antidepressant medications are highly protein bound (>95%), with the exception of venlafaxine
(27%), desvenlafaxine (30%), levomilnacipran (22%), and escitalopram (56%). There
fore, most antidepressants can displace drugs such as warfarin in plasma proteins.
Finally, a third risk for drug-drug interaction is that some medications inhibit CYP
enzymes, the microsomal enzymes of the liver that metabolize many drugs before
they are cleared from the body (see Tables 15–3 and 15–4). The antidepressants themselves are broken down by these enzymes, and some even inhibit their own metabolism. CYP2D6 is strongly inhibited by fluoxetine and paroxetine and weakly inhibited
by sertraline and citalopram (Nemeroff et al. 1996). Drugs that are normally metabo
lized by this isoform include antipsychotics, antiseizure medication, β-blockers, and
angiotensin-converting enzyme inhibitors. CYP3A4 is inhibited by nefazodone, norfluoxetine, and fluvoxamine, and thus these drugs can cause increased plasma levels
of cyclosporine and other drugs metabolized by CYP3A4 (Nemeroff et al. 1996). Venlafaxine and mirtazapine may have lower potential for drug-drug interactions than
other antidepressants.
and possibly 5-HT2 re-
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264 The APA Publishing Textbook of Mood Disorders, Second Edition
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Conclusion
The introduction of SSRIs and newer antidepressants has dramatically changed the
treatment of depression over the past three decades. Earlier antidepressants such as
the TCAs were effective but had significant side effects because they interacted with
various neurotransmitter receptors. SSRIs rapidly became the most widely prescribed
class of antidepressants—indeed, one of the most widely prescribed classes of drugs—
and have been used for the treatment of depression in millions of people worldwide.
Although questions remain about their comparative effectiveness, they continue to be
widely used. These medications remain the mainstays of MDD treatment.
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CHAPTER 16
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Lithium
and Mood Stabilizers
Keming Gao, M.D., Ph.D.
Yuanhan Bai, M.D., M.S.
Joseph R. Calabrese, M.D.
Mood stabilizers are not only the cornerstone for the clinical management
of bipolar disorder (Gao et al. 2015a) but also commonly recognized as possessing
efficacy in the treatment of major depressive disorder (MDD) (Zhou et al. 2015). An
ideal mood stabilizer would exhibit a broad spectrum of efficacy that covers all acute
phases (depression, mania, and hypomania) and psychosis, prevents all abnormal
mood variations of bipolar disorder, and does not aggravate or worsen any feature of
the illness. However, all medications approved for bipolar disorder by the FDA have
been based on the efficacy of a medication in the acute treatment of mania or bipolar
depression or of a medication that prevents the relapse of any mood episodes (Gao et
al. 2015a). Therefore, any medication approved for any phase of bipolar treatment can
be considered a mood stabilizer. Accordingly, lithium, valproic acid/divalproex, lamo
trigine, carbamazepine, and almost all atypical antipsychotics are mood stabilizers
(Gao et al. 2015a).
While the evidence of efficacy of these drugs in bipolar disorder is strongly supported by large randomized, double-blind, placebo-controlled trials (DBPCTs), the
evidence of efficacy in MDD is less convincing, although some atypical antipsychot
ics have been approved as adjunctive therapy to traditional antidepressants for treatment-resistant MDD (Aftab and Gao 2017). This chapter discusses use of lithium and
anticonvulsant mood stabilizers, including valproic acid/divalproex, lamotrigine, and
carbamazepine, in the treatment of mood disorders.
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