Psychiatry and Clinical Neurosciences 2015; 69: 4348

doi:10.1111/pcn.12212

Regular Article

Open prospective study of ziprasidone in patients

with schizophrenia with depressive symptoms:
A multicenter study
Woo-Young Jung, MD,1 Sung-Gon Kim, MD, PhD,2* Jin-Seong Lee, MD,1
Dong-Ho Kang, MD, PhD,4 Bong-Joo Jung, MD, PhD,3 Dong-Hun Shin, MD,5
Young-Min Lee, MD6 and Sang-Heon Choi, MD5
1

Department of Psychiatry, Pusan National University Yangsan Hospital, Pusan National University School of Medicine,
Department of Psychiatry, School of Medicine, Pusan National University, 3Yang-San Neuropsychiatric Hospital, Yangsan,
4
Haeundae Jamyung Hospital, 5Dongrae Hospital, and 6Department of Psychiatry, Pusan National University Hospital,
Pusan National University School of Medicine, Busan, Korea
2

Aims: The goal of this study was to examine the efficacy and safety of ziprasidone to treat depressive
symptoms in Korean patients with schizophrenia
who showed stable symptoms.
Methods: In this 8-week, open-label, prospective,
non-randomized, multicenter study, 34 patients with
schizophrenia who showed a stable response to previous medications, maintained a stable dose, and
who had depressive symptoms, were recruited.
Ziprasidone was the only antipsychotic agent allowed
for 8 weeks after a 27-week washout period.
Results: Steady decreases were observed on the
MontgomeryAsberg Depression Rating Scale, the
Calgary Depression Scale for Schizophrenia, the Positive and Negative Syndrome Scale, and the Clinical
Global Impression-Severity Scale scores. The
MontgomeryAsberg Depression Rating Scale score
was 20.26 4.77 at baseline and 12.21 7.94 at the
end-point (P < 0.01). The Calgary Depression Scale
for Schizophrenia score was 9.76 4.11 at baseline

LTHOUGH POSITIVE AND negative symptoms

conceptualize the core domains of schizophrenia, additional symptom domains, including depres-

*Correspondence: Sung-Gon Kim, MD, PhD, Department of

Psychiatry, School of Medicine, Pusan National University, Pusan
National University Yangsan Hospital, Mulgeum-eup, Yangsan-si,
Gyeongnam 626-770, Korea. Email: sungkim@pusan.ac.kr
Received 10 February 2014; revised 1 May 2014; accepted 2 June
2014.

and 5.00 3.94 at the end-point (P < 0.01). The Positive and Negative Syndrome Scale total score was
75.24 22.63 at baseline and 66.53 24.28 at
the end-point (P < 0.01). The Clinical Global
Impression-Severity Scale score was 3.44 0.66 at
baseline and 3.15 0.86 at the end-point (P < 0.05).
No significant differences were observed for total
scores on the Simpson and Angus Rating Scale, the
Barnes Akathisia Rating Scale, or the Abnormal Involuntary Movement Scale between the baseline and
end-point.

Conclusions: Ziprasidone was effective for improving

depressive symptom scores and was well tolerated.
Switching to ziprasidone is a good strategy in patients
with schizophrenia who are experiencing depressive
symptoms.
Key words: depressive symptom, schizophrenia,
switch, ziprasidone.

sive symptoms, have been verified in patients

with schizophrenia.1 Depressive symptoms are not
rare in psychotic disorders, as demonstrated by
point-prevalence figures of 775% in patients with
schizophrenia.2
Depressive symptoms in patients with schizophrenia must be evaluated and managed because they are
associated with less favorable clinical outcomes,
including increased rates of relapse and rehospitalization, poor social functioning, greater cognitive

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43

44

W-Y. Jung et al.

impairment, poor quality of life, increased mortality

related to suicide, and poor response to pharmacological treatments. Therefore, early detection and
treatment of depressive symptoms in patients with
schizophrenia is very important, and optimal management should concurrently treat patients for all
schizophrenia symptom domains.3
Depression commonly occurs in patients with
schizophrenia and has clinical significance. Few
studies have demonstrated the possible clinical
advantage of using antidepressants to manage
depression in patients with schizophrenia, suggesting
that the use of antidepressants is unreliable.4 The
efficacy of treatment with antidepressants is restricted
and antidepressants can aggravate psychosis during
the acute phase.5 In addition, there is a hazard of
pharmacokinetic interactions, particularly with selective serotonin reuptake inhibitors.6
Atypical antipsychotics have emerged as a new
choice for managing depressive symptoms in
patients with schizophrenia. Several studies have
reported that several atypical antipsychotics, such as
risperidone, olanzapine, quetiapine, ziprasidone
and amisulpride, are beneficial to treat concurrent
depressive symptoms in patients with schizophrenia.712 In particular, results of a double-blind,
placebo-controlled, multicenter study of 139 patients
with an acute exacerbation of schizophrenia or
schizoaffective disorder showed that ziprasidone is
significantly more effective than placebo for improving depression cluster and anergia cluster scores.13 In
another 6-week, multicenter, double-blind study,
ziprasidone and olanzapine treatment both resulted
in rapid improvement in positive and negative
symptoms and depressive symptoms in acutely ill
inpatients with schizophrenia and schizoaffective
disorder.14
However, previous studies included mostly acutely
ill patients with schizophrenia, and recent clinical
findings show that depressive symptoms during the
acute phase respond well to antipsychotic treatment
and are positive prognostic factors, whereas depressive symptoms in the post-psychotic phase are linked
with poor prognosis and respond poorly to antidepressants.4 Studies in Korea to identify the antidepressive effect of ziprasidone in patients with
schizophrenia and the stabilized symptoms are rare
or have shown limited results due to a relatively small
number of subjects.
Therefore, the objective of this study was to
examine the efficacy and safety of ziprasidone to treat

Psychiatry and Clinical Neurosciences 2015; 69: 4348

depressive symptoms in Korean patients with schizophrenia who showed stable symptoms.

METHODS
This was an 8-week, open-label, prospective, nonrandomized, multicenter study.

Participants
The study was conducted at eight hospital sites in
Korea. It included patients aged 1860 years who met
the DSM-IV diagnostic criteria for schizophrenia,
who showed a stable response to previous medications and maintained a stable dose for 2 weeks, and
who had depressive symptoms as defined by a score
of 1432 on the MontgomeryAsberg Depression
Rating Scale (MADRS) and had a score of 2 on the
MADRS suicide items.
Patients were excluded from the trial for: (i)
meeting DSM-IV criteria for abuse or dependence on
alcohol or other substances; (ii) having a serious and
unstable medical or surgical illness; (iii) using an
antidepressant during the previous 2 weeks; (iv)
scoring 33 on the MADRS; and (v) scoring 4 on the
MADRS suicide items. Pregnant or lactating women
were also excluded.
Written informed consent was obtained from all
enrolled patients. This trial was approved by the institutional review board of Pusan National University
Hospital, Korea.

Study design
Patients receiving antipsychotics underwent a washout period of 27 days as judged by a clinician. During
the washout period, minimal doses of anticholinergics or benzodiazepines were used to control withdrawal symptoms from previous antipsychotics or
aggravation of psychotic symptoms. The initial dose of
ziprasidone was 40 mg/day. The dose was increased to
80160 mg/day within 8 weeks and divided into
two doses per day. Titration of dosing was conducted
every 7 days depending on the patients condition.
However, titration was conducted at a 2-day interval
when required clinically.
Concomitant anticholinergics, benzodiazepines,
or hypnotics were allowed for side-effects or insomnia if required during the study, but were not administered prophylactically, and were used at a minimal
dose for a minimal duration. Ziprasidone was the

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Psychiatry and Clinical Neurosciences 2015; 69: 4348

only antipsychotic agent, and no other antipsychotics

or mood stabilizers were permitted.

Assessments
Data on demographic and clinical characteristics at
baseline were obtained (age, sex, and age of onset).
This study focused on depressive symptoms in
patients with schizophrenia; thus, the primary
outcome was to measure depressive symptoms using
the Calgary Depression Scale for Schizophrenia
(CDSS) and the MADRS at baseline, and at weeks 2,
4, and 8. The CDSS was developed to measure
depressive symptoms in patients with schizophrenia.
A study on the reliability and validity of the Korean
version of the CDSS reported that the K-CDSS is correlated with the MADRS in Korean patients with
schizophrenia.3 However, the reliability and specificity of the MADRS for evaluating depressive symptoms
in patients with schizophrenia has not been estimated in a foreign study to the same extent as they
have for the CDSS.15 Therefore, we used both MADRS
and CDSS to enhance the accuracy of measuring
depressive symptoms in patients with schizophrenia.
Additionally, the Positive and Negative Syndrome
Scale (PANSS) and Clinical Global Impression Severity scale score (CGI-S) at baseline, and at weeks 2, 4,
and 8 were also measured to assess the efficacy of
ziprasidone. Adverse effects related to extrapyramidal
syndrome (EPS) were evaluated using the Simpson
and Angus Rating Scale (SAS), the Barnes Akathisia
Rating Scale (BARS), and the Abnormal Involuntary
Movement Scale (AIMS) at baseline, and weeks 2, 4,
and 8. In addition, any spontaneous self-reports and
observed adverse effects were recorded throughout
the trial.

Statistical analyses
An intent-to-treat analysis was used to evaluate the
overall efficacy and safety of ziprasidone. Regardless
of inclusion criteria, protocol violation, and dropout,
the end-point analysis included results from all subjects who took ziprasidone. Missing values due to
dropout were analyzed with the last observation
carried forward (LOCF) method in which missing
values are replaced by the last observed value for that
variable. Total scores on the CDSS, MADRS, PANSS,
and CGI-S, SAS, BARS, and AIMS at baseline, weeks 2,
4, and 8 (end-point) were analyzed with the paired
t-test.

Ziprasidone for depressive symptoms 45

The response to treatment at the end-point was

defined as 50% reduction in baseline MADRS and
CDSS total scores. Remission to treatment was
defined as a CDSS total score <8 at the end-point.15,16

RESULTS
Demographic and clinical characteristics of
the patients
Thirty-four subjects with an average age of
41.06 8.62 years were enrolled (14 men, 41% and
20 women, 59%). Five subjects dropped out, and
their last available assessment after baseline was used
as the end-point with the LOCF approach. Twentynine subjects completed the 8-week trial.
Age at onset of schizophrenia was 27.65 7.38
years. Total scores on the MADRS, CDSS, PANSS,
and CGI-S at baseline were 20.26 4.77, 9.76
4.11, 75.24 22.63, and 3.44 0.66, respectively
(Table 1). Thirty patients were given antipsychotic
monotherapy before washout (quetiapine, one
subject; amisulpride, one subject; clozapine, one
subject; zotepine, two subjects; haloperidol, four subjects; olanzapine, five subjects; aripiprazole, five subjects; risperidone, 11 subjects) and four patients were
given antipsychotic combination therapy (haloperidol + chlorpromazine, one subject; risperidone +
zotepine, one subject; haloperidol + quetiapine, two
subjects).

Table 1. Demographic and clinical characteristics of

the patients (n = 34)
Characteristics

n (%) or mean

Age
Sex
Male
Female
Age at onset of schizophrenia
At baseline, total score of
MADRS
CDSS
PANSS
CGI-S

41.06 8.62
14 (41%)
20 (59%)
27.65 7.38
20.26 4.77
9.76 4.11
75.24 22.63
3.44 0.66

CDSS, Calgary Depression Scale for Schizophrenia;

CGI-S, Clinical Global Impression scale; MADRS,
MontgomeryAsberg Depression Rating Scale; PANSS,
Positive and Negative Syndrome Scale.

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W-Y. Jung et al.

Psychiatry and Clinical Neurosciences 2015; 69: 4348

Table 2. Changes in the four scores (mean SD) of the efficacy measures over time (n = 34)

Baseline
Week 2
Week 4
Week 8

MADRS

CDSS

PANSS

CGI-S

20.26 4.77
17.26 4.65**
13.74 7.24**
12.21 7.94**

9.76 4.11
7.79 3.53**
5.97 3.97**
5.00 3.94**

75.24 22.63
72.97 22.63
68.47 23.74*
66.53 24.28*

3.44 0.66
3.44 0.66
3.41 0.74
3.15 0.86*

*P < 0.05; **P < 0.01 compared with baseline.

CDSS, Calgary Depression Scale for Schizophrenia; CGI-S, Clinical Global Impression scale; MADRS,
MontgomeryAsberg Depression Rating Scale; PANSS, Positive and Negative Syndrome Scale.

Dosing and concomitant medications

The end-point daily doses of ziprasidone were
114.71 34.92 mg/day (maximum 160 mg/day).
The percentages of patients who received
benztropine, beta-adrenergic antagonists, or benzodiazepines at any time during the study were 26%
(nine subjects), 6% (two subjects), and 53% (18 subjects), respectively. Stilnox (four subjects) and
trazodone (one subject) for sleep control, valproate
(three subjects) for impulse control, piprinhydrinate
(one subject) as an antihistamine for rash and itching
control, amlodipine (one subject) as a calcium
channel blocker for hypertension, and aspirin (one
subject) for preventing atherosclerosis were used by
judgment of a physician during the study.

Efficacy
Decreases were steadily observed on the MADRS,
CDSS, PANSS, and CGI-S scores as time passed.
However, the first time to significant improvement
on each scale was different. Significant reductions in
MADRS and CDSS scores were identified as quickly as
week 2. However, significant improvements in the
PANSS and CGI-S total scores were observed on
weeks 4 and 8, respectively.
The MADRS score was 20.26 4.77 at baseline and
12.21 7.94 at the end-point (P < 0.01). The CDSS
score was 9.76 4.11 at baseline and 5.00 3.94 at
the end-point (P < 0.01). The PANSS total score was
75.24 22.63 at baseline and 66.53 24.28 at
the end-point (P < 0.01). The CGI-S score was
3.44 0.66 at baseline and 3.15 0.86 at the endpoint (P < 0.05) (Table 2).
At the end-point, 44% (n = 15) and 53% (n = 18)
of the patients met the response criteria as measured

by the MADRS and CDSS. A total of 74% (n = 25)

of patients met remission criteria as measured
by the CDSS. All patients who met the response criteria as measured by the CDSS also met the remission criteria as measured by the CDSS at the
end-point.

Safety and tolerability

No significant differences were observed for total
scores on the SAS, BARS, and AIMS between the baseline and end-point (Table 3).

DISCUSSION
The primary objective of this study was to examine
the efficacy and safety of ziprasidone for treating
depressive symptoms in Korean patients with schizophrenia who showed stable symptoms. Overall,
scores on the MADRS, CDSS, PANSS, and CGI-S
decreased as time passed. At the end-point, nearly
half of the patients met the response criteria as

Table 3. Scores (mean SD) for the extrapyramidal

side-effect measures over time (n = 34)

Baseline
Week 2
Week 4
Week 8

SAS

BARS

AIMS

2.62 3.48
2.85 3.89
2.44 3.69
2.06 3.24

0.88 1.51
1.03 1.92
1.09 2.38
0.53 1.21

0.65 1.79
0.74 1.91
0.38 0.82
0.35 0.73

AIMS, Abnormal Involuntary Movement Scale; BARS,

Barnes Akathisia Rating Scale; SAS, Simpson and
Angus Rating Scale.

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Psychiatry and Clinical Neurosciences 2015; 69: 4348

measured by the MADRS and CDSS. Total scores on

the SAS, BARS, and AIMS were not significantly different between baseline and the end-point, and 85%
of the patients completed the 8-week trial. These
results indicate that ziprasidone has efficacy and tolerability for treating depressive symptoms in patients
with schizophrenia.
Another study in Korea supported these results.
Zhao et al. verified that ziprasidone is effective for
managing positive, negative, and depressive symptoms during first-episode psychosis. In that study,
significant improvements in PANSS total and positive subscale scores appeared as quickly as 1 week
and significant improvement in the CDSS score
was detected on week 8 after administration of
ziprasidone, although 16 patients dropped out
among the 27 enrolled patients.17 In the present
study, a significant reduction in depressive symptoms scores was identified as quickly as week 2.
However, significant improvements in the PANSS
total score were observed at week 4. These difference
may have been caused by patient selection (present
study, schizophrenia with stabilized symptom vs
first episode psychosis in Zhaos study) and endpoint ziprasidone doses (present study, 114.71
34.92 mg/day vs 131.85 51.22 mg/day in Zhaos
study). A significant reduction in depressive symptoms may not indicate an indirect effect secondary
to reduction of schizophrenic symptoms if the
improvement order of symptom domains is considered in the present study.
In addition, other studies have been conducted on
the anti-depressive effect of ziprasidone in patients
with schizophrenia. Daniel et al. reported that depressive symptoms in patients with acute exacerbated
schizophrenia and clinically significant depression at
baseline improved with 160-mg/day ziprasidone
compared with those in a placebo group.18 Kim et al.
reported significant reductions in scores on the CDSS
and Beck Depression Inventory at the end-point
after switching from aripiprazole to ziprasidone.19
According to our results and those of previous
studies, ziprasidone can be used as an option for
treating depressive symptoms in Korean patients with
schizophrenia.
Ziprasidone is an atypical antipsychotic with a
high serotonin-2/dopamine-2 (5-HT2/D2) receptorbinding ratio and binds to several receptors.10
Ziprasidone has high affinity for dopamine D2, D3,
serotonin 5HT1A, 5HT1D, 5HT2A, and 5HT2C
receptors and relatively moderate affinity for hista-

Ziprasidone for depressive symptoms 47

mine H1 and adrenergic- receptors. It has low affinity for dopamine D1 and 2 receptors and negligible
affinity for adrenergic and muscarinic, nicotinic
receptors. Also, ziprasidone inhibits 5HT and norepinephrine re-uptake moderately. The actions of
ziprasidone as a potent 5HT1A receptor agonist, a
potent 5-HT1D and 5-HT2C receptor antagonist, and
a moderate inhibitor of norepinephrine and serotonin re-uptake are expected to be effective for affective as well as positive and negative symptoms.13
Therefore, the significant improvement in the depressive symptom scale shown in the present study may
be a result of a direct anti-depressant effect of
ziprasidone.
The higher ratio of affinity for 5HT2A receptors
compared to D2 receptors means that it is less likely
to induce extrapyramidal side-effects. Depressive
symptoms in patients with schizophrenia are similar
to EPS. In particular, drug-induced parkinsonism
may look like a depressive state.20 In the present
study, the dropout rate was relatively low and there
was no exacerbation of EPS scales. A significant
reduction in depressive symptoms may not indicate
an indirect effect on EPS in the present study considering the lack of a significant difference in total scores
of the SAS, BARS, and AIMS between the baseline and
end-point. Therefore, ziprasidone was well tolerated
by Korean patients with schizophrenia and depressive symptoms.
There were several limitations in the present study.
This was an open-prospective study that might be
biased in evaluating patients. In addition, it was not
a randomized controlled study. Therefore, there was
no comparative group. However, compared with previous studies, we identified an anti-depressive effect
of ziprasidone in patients with schizophrenia and
stable symptoms.

Conclusion
We examined the efficacy and safety of ziprasidone
for treating depressive symptoms in Korean patients
with schizophrenia who showed stable symptoms.
We found that ziprasidone was effective for improving depressive symptom scores and was well
tolerated. These results indicate that ziprasidone
is effective for treating depressive symptoms in
Korean patients with schizophrenia. Switching to
ziprasidone is a good strategy in patients with schizophrenia who are experiencing depressive symptoms
simultaneously.

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W-Y. Jung et al.

Psychiatry and Clinical Neurosciences 2015; 69: 4348

ACKNOWLEDGMENTS
This study was supported by Pfizer Pharmaceuticals
Korea. The authors had no conflicts of interest in
conducting this study or preparing the manuscript.

11.

12.

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