Psychopharmacology

Efficacy and Effectiveness of Antidepressants: Current Status of Research

Abstract Background: This paper examines the current status of research on the efficacy and
effectiveness of antidepressants. Methods: This paper reviews four meta-analyses of
efficacy trials submitted to America’s Food and Drug Administration (FDA) and analyzes
STAR * D (Sequenced Treatment Alternatives to Relieve Depression), the largest
antidepressant effectiveness trial ever conducted. Results: Meta-analyses of FDA trials
suggest that antidepressants are only marginally efficacious compared to placebos and
document profound publication bias that inflates their apparent efficacy. These meta-
analyses also document a second form of bias in which researchers fail to report the
negative results for the prespecified primary outcome measure submitted to the FDA, while
highlighting in published studies positive results from a secondary or even a new measure as
though it was their primary measure of interest. The STAR * D analysis found that the
effectiveness of antidepressant therapies was probably even lower than the modest one
reported by the study
Key considerations for long-term studies
with anxiolytics
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Summary
Long-term (minimum six months) safety and efficacy studies with an anti-anxiety
agent are aimed at identifying the emergence of any clinical effects not observed
during shorter periods of treatment including the identification of late occurring
adverse events, loss of therapeutic benefit, or post-treatment withdrawal effects.
There is the need to establish diagnostic criteria for persistent anxiety for patients
who truly benefit from long-term therapy. Risk factors predisposing to drug
dependence should be assessed prior to continuous use. Ideally, long-term
continuous studies should be blinded, comparative and placebo-controlled, with an
adequate duration of the withdrawal phase. The treatment response of the elderly in
comparison to the overall patient sample should be emphasised.
LONG TERM EFFECTIVENESS OF MOOD STABLIZER IN TREATING BPAD:META ANALYSIS

Abstract
OBJECTIVE: The term “mood stabilizer” is widely used in the context of
treating bipolar disorder, but the U.S. Food and Drug Administration (FDA)
does not officially recognize the term, and no consensus definition is accepted
among investigators. The authors propose a “two-by-two” definition by which
an agent is considered a mood stabilizer if it has efficacy in treating acute
manic and depressive symptoms and in prophylaxis of manic and depressive
symptoms in bipolar disorder. They review the literature on the efficacy of
agents in any of these four roles to determine which if any agents meet this
definition of mood stabilizer. METHOD: The authors conducted a
comprehensive review of English-language literature describing peer-
reviewed, U.S. Agency for Healthcare Research and Quality class A controlled
trials in order to identify agents with efficacy in any of the four roles included
in their definition of a mood stabilizer. The trials were classified as positive or
negative on the basis of primary outcome variables. An “FDA-like” criterion of
at least two positive placebo-controlled trials was required to consider an
agent efficacious. The authors also conducted a sensitivity analysis by raising
and relaxing the criteria for including trials in the review. RESULTS: The
authors identified 551 candidate articles, yielding 111 class A trials, including
81 monotherapy trials with 95 independent analyses published through June
2002. Lithium, valproate, and olanzapine had unequivocal evidence for
efficacy in acute manic episodes, lithium in acute depressive episodes and in
prophylaxis of mania and depression, and lamotrigine in prophylaxis (relapse
polarity unspecified). Thus, only lithium fulfilled the a priori definition of a
mood stabilizer. Relaxing the quality criterion did not change this finding,
while raising the threshold resulted in no agents fulfilling the
definition. CONCLUSIONS: When all four treatment roles are considered,
the evidence supported a role for lithium as first-line agent for treatment of
bipolar disorder. The analysis also highlights unmet needs and promising
agents and provides a yardstick for evaluating new treatment strategies.
Disulfiram Efficacy in the Treatment of Alcohol Dependence: A
Meta-Analysis
Marilyn D. Skinner, 1 , * Pierre Lahmek, 2 Héloïse Pham, 3 and Henri-Jean Aubin 4

Jerson Laks, Editor

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Associated Data
Supplementary Materials

Abstract
Despite its success with compliant or supervised patients, disulfiram has been a controversial
medication in the treatment of alcoholism. Often, study designs did not recognize a pivotal
factor in disulfiram research, the importance of an open-label design. Our objectives are: (1)
to analyze the efficacy and safety of disulfiram in RCTs in supporting abstinence and (2) to
compare blind versus open-label studies, hypothesizing that blinded studies would show no
difference between disulfiram and control groups because the threat would be evenly spread
across all groups.
Adverse Effects of Psychotropic Medications in Children:
Predictive Factors
Ajit Ninan, MD, FRCPC,1,2 Shannon L. Stewart, PhD, CPsych,2,1 Laura A. Theall, MSc,1 Shehan
Katuwapitiya, BMSc,2 and Chester Kam, PhD3

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AbstractDespite limited information related to efficacy in

children, psychotropic medications are commonly prescribed
as a first-line treatment for a range of psychiatric diagnoses in
children in a variety of clinical settings. Usage has increased
over the past three decades. Although psychotropic
medications are often effective at treating psychiatric
symptoms, the risk of adverse effects (AE) in children is
unclear. The current research seeks to identify the mental
health characteristics of those children at highest risk of
experiencing potential AE from psychotropic medications
The Geriatric Population and Psychiatric Medication
Sannidhya Varma, MBBS,* Himanshu Sareen, MD,** and J.K. Trivedi***

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Abstract
With improvement in medical services in the last few years, there has
been a constant rise in the geriatric population throughout the world,
more so in the developing countries. The elderly are highly prone to
develop psychiatric disorders, probably because of age related
changes in the brain, concomitant physical disorders, as well as
increased stress in later life. Psychiatric disorders in this population
may have a different presentation than in other groups and some of
psychopathologies might be mistaken for normal age related changes
by an unwary clinician. Therefore the need of the day is to train
psychiatrists and physicians to better recognize and manage mental
disorders in this age group.
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SLN CONTENT PG NO
O
 Assignment on drug book

Submitted by
Maj Mercy Jacob
1st yr MSc Trainee officer
Con CH(EC)
Kolkata