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 Educational Resources
Online Assessment Measures
For further clinical evaluation and research, the APA is offering a number of “emerging measures” in Section III of
DSM–5. These patient assessment measures were developed to be administered at the initial patient interview
and to monitor treatment progress, thus serving to advance the use of initial symptomatic status and patient
reported outcome (PRO) information, as well as the use of “anchored” severity assessment instruments.
Instructions, scoring information, and interpretation guidelines are included. Clinicians and researchers may
provide APA with feedback on the instruments’ usefulness in characterizing patient status and improving patient
care.
Level 1 Cross-Cutting Symptom Measures
DSM–5 Self-Rated Level 1 Cross-Cutting Symptom Measure, Adult (also available in print book)
DSM–5 Parent/Guardian-Rated Level 1 Cross-Cutting Symptom Measure, Child Age 6, 17 (also available in
print book)
DSM–5 Self-Rated Level 1 Cross-Cutting Symptom Measure, Child Age 11 to 17
Level 2 Cross-Cutting Symptom Measures
For Adults
LEVEL 2, Depression, Adult (PROMIS Emotional Distress, Depression, Short Form)
LEVEL 2, Anger, Adult (PROMIS Emotional Distress, Anger, Short Form)
LEVEL 2, Mania, Adult (Altman Self-Rating Mania Scale [ASRM])
LEVEL 2, Anxiety, Adult(PROMIS Emotional Distress, Anxiety, Short Form)
LEVEL 2, Somatic Symptom, Adult (Patient Health Questionnaire 15 Somatic Symptom Severity Scale [PHQ15])
LEVEL 2, Sleep Disturbance, Adult (PROMIS, Sleep Disturbance, Short Form)
LEVEL 2, Repetitive Thoughts and Behaviors, Adult (Adapted from the Florida Obsessive-Compulsive
Inventory [FOCI] Severity Scale [Part B])
LEVEL 2, Substance Use, Adult (Adapted from the NIDA-Modified ASSIST)
For Parents of Children Ages 6, 17
LEVEL 2, Somatic Symptom, Parent/Guardian of Child Age 6, 17 (Patient Health Questionnaire 15 Somatic
Symptom Severity Scale [PHQ-15])
LEVEL 2, Sleep Disturbance, Parent/Guardian of Child Age 6, 17 (PROMIS, Sleep Disturbance, Short Form)
LEVEL 2, Inattention, Parent/Guardian of Child Age 6, 17 (Swanson, Nolan, and Pelham, version IV [SNAP-IV])
LEVEL 2, Depression, Parent/Guardian of Child Age 6, 17 (PROMIS Emotional Distress, Depression, Parent
Item Bank)
LEVEL 2, Anger, Parent/Guardian of Child Age 6, 17 (PROMIS Emotional Distress, Calibrated Anger Measure,
Parent)
LEVEL 2, Irritability, Parent/Guardian of Child Age 6, 17 (Affective Reactivity Index [ARI])
LEVEL 2, Mania, Parent/Guardian of Child Age 6, 17 (Adapted from the Altman Self-Rating Mania Scale
[ASRM])
LEVEL 2, Anxiety, Parent/Guardian of Child Age 6, 17 (Adapted from PROMIS Emotional Distress, Anxiety,
Parent Item Bank)
LEVEL 2, Substance Use, Parent/Guardian of Child Age 6, 17 (Adapted from the NIDA-Modified ASSIST)
For Children Ages 11 to 17
LEVEL 2, Somatic Symptom, Child Age 11 to 17 (Patient Health Questionnaire 15 Somatic Symptom Severity
Scale [PHQ-15])
LEVEL 2, Sleep Disturbance, Child Age 11 to 17 (PROMIS, Sleep Disturbance, Short Form)
LEVEL 2, Depression, Child Age 11 to 17 (PROMIS Emotional Distress, Depression, Pediatric Item Bank)
LEVEL 2, Anger, Child Age 11 to 17 (PROMIS Emotional Distress, Calibrated Anger Measure, Pediatric)
LEVEL 2, Irritability, Child Age 11 to 17 (Affective Reactivity Index [ARI])
LEVEL 2, Mania, Child Age 11 to 17 (Altman Self-Rating Mania Scale [ASRM])
LEVEL 2, Anxiety, Child Age 11 to 17 (PROMIS Emotional Distress, Anxiety, Pediatric Item Bank)
LEVEL 2, Repetitive Thoughts and Behaviors, Child Age 11 to 17 (Adapted from the Children’s Florida
Obsessive Compulsive Inventory [C-FOCI] Severity Scale)
LEVEL 2, Substance Use, Child Age 11 to 17 (Adapted from the NIDA-Modified ASSIST)
– Disorder-Specific Severity Measures
For Adults
Severity Measure for Depression, Adult(Patient Health Questionnaire [PHQ-9])
Severity Measure for Separation Anxiety Disorder, Adult
Severity Measure for Specific Phobia, Adult
Severity Measure for Social Anxiety Disorder (Social Phobia), Adult
Severity Measure for Panic Disorder, Adult
Severity Measure for Agoraphobia, Adult
Severity Measure for Generalized Anxiety Disorder, Adult
Severity of Posttraumatic Stress Symptoms, Adult (National Stressful Events Survey PTSD Short Scale
[NSESS])
Severity of Acute Stress Symptoms, Adult (National Stressful Events Survey Acute Stress Disorder Short
Scale [NSESS])
Severity of Dissociative Symptoms, Adult (Brief Dissociative Experiences Scale [DES-B])
For Children Ages 11 to 17
Severity Measure for Depression, Child Age 11 to 17 (PHQ-9 modified for Adolescents [PHQ-A], Adapted)
Severity Measure for Separation Anxiety Disorder, Child Age 11 to 17
Severity Measure for Specific Phobia, Child Age 11 to 17
Severity Measure for Social Anxiety Disorder (Social Phobia), Child Age 11 to 17
Severity Measure for Agoraphobia, Child Age 11 to 17
Severity Measure for Generalized Anxiety Disorder, Child Age 11 to 17
Severity of Posttraumatic Stress Symptoms, Child Age 11 to 17 (National Stressful Events Survey PTSD
Short Scale [NSESS])
Severity of Acute Stress Symptoms, Child Age 11 to 17 (National Stressful Events Survey Acute Stress
Disorder Short Scale [NSESS])
Severity of Dissociative Symptoms, Child Age 11 to 17 (Brief Dissociative Experiences Scale [DES-B])
Clinician-Rated
Clinician-Rated Severity of Autism Spectrum and Social Communication Disorders
Clinician-Rated Dimensions of Psychosis Symptom Severity(also available in print book)
Clinician-Rated Severity of Somatic Symptom Disorder
Clinician-Rated Severity of Oppositional Defiant Disorder
Clinician-Rated Severity of Conduct Disorder
Clinician-Rated Severity of Nonsuicidal Self-Injury
– Disability Measures
WHODAS 2.0 (World Health Organization Disability Schedule 2.0, 36-item version, self-administered. Also
available in print book)
WHODAS 2.0 (World Health Organization Disability Schedule 2.0, 36-item version, proxy-administered)
– Personality Inventories
For Adults
The Personality Inventory for DSM–5, Brief Form (PID-5-BF), Adult
The Personality Inventory for DSM–5 (PID-5), Adult
The Personality Inventory for DSM–5, Informant Form (PID-5-IRF), Adult
For Children Ages 11 to 17
The Personality Inventory for DSM–5, Brief Form (PID-5-BF), Child Age 11 to 17
The Personality Inventory for DSM–5 (PID-5), Child Age 11 to 17
– Early Development and Home Background
For Parents of Children Ages 6 to 17
Early Development and Home Background (EDHB) Form, Parent/Guardian
Clinician-Rated
Early Development and Home Background (EDHB) Form, Clinician
Cultural Formulation Interviews
Cultural Formulation Interview (also available as a print book)
Cultural Formulation Interview, Informant Version (also available in print book)
Supplementary Modules to the Core Cultural Formulation Interview (CFI)
About the Measures
These measures should be used to enhance clinical decision-making and not as the sole basis for
making a clinical diagnosis. Further information on these measures can be found in DSM–5. The
measures can be broadly classified into four types:
1. Cross-cutting symptom measures may aid in a comprehensive mental status assessment by drawing
attention to symptoms that are important across diagnoses. They are intended to help identify
additional areas of inquiry that may guide treatment and prognosis. The cross-cutting measures have
two levels: Level 1 questions are a brief survey of 13 domains for adult patients and 12 domains for
child and adolescent patients, and Level 2 questions provide a more in-depth assessment of certain
domains.
2. Severity measures are disorder-specific, corresponding closely to criteria that constitute the disorder
definition. They may be administered to individuals who have received a diagnosis or who have a
clinically significant syndrome that falls short of meeting full criteria. Some of the assessments are
self-completed, whereas others require a clinician to complete.
3. The World Health Organization Disability Assessment Schedule, Version 2.0 (WHODAS 2.0) assesses
a patient’s ability to perform activities in six areas: understanding and communicating; getting around;
self-care; getting along with people; life activities (e.g., household, work/school); and participation in
society. The scale is self- or informant-administered and corresponds to concepts contained in the
WHO International Classification of Functioning, Disability and Health.
4. The Personality Inventories for DSM–5 measure maladaptive personality traits in five domains:
negative affect, detachment, antagonism, disinhibition, and psychoticism. For adults and children
ages 11 and older, there are brief forms with 25 items and full versions with 220 items. A full version
for informants is also available.
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Psychopharmacology (2011) 216:475–484
DOI 10.1007/s00213-011-2242-3
ORIGINAL INVESTIGATION
Effectiveness of maintenance treatments with atypical
and typical antipsychotics in stable schizophrenia
with early stage: 1-year naturalistic study
Xiaofeng Guo & Maosheng Fang & Jinguo Zhai & Bo Wang & Chuanyue Wang & Bin Hu &
Xueli Sun & Luxian Lv & Zheng Lu & Cui Ma & Tiansheng Guo & Shiping Xie &
Elizabeth W. Twamley & Hua Jin & Jingping Zhao
Received: 16 November 2010 / Accepted: 18 February 2011 / Published online: 3 March 2011
# Springer-Verlag 2011
Abstract
Rationale The relative effectiveness of the atypical antipsychotic drugs and conventional agents in patients with
early-stage schizophrenia has not been comprehensively
determined.
Objectives The aim of our study was to evaluate the
efficacy and safety of seven antipsychotic drugs for the
maintenance treatment in patients with early-stage
schizophrenia.
Methods In a 12-month open-label, prospective observational, multicenter study, 1,133 subjects with schizophrenia or schizophreniform disorder within 5 years of
onset were monotherapy with chlorpromazine, sulpiride,
clozapine, risperidone, olanzapine, quetiapine, or aripiprazole. The primary measure was the rate of treatment
discontinuation for any reason. Secondary outcomes
included measures for clinical and functional outcomes
and tolerability.
Clinical Trials.gov Identifier: NCT00654576
Guo and Fang contributed equally to the study.
X. Guo : M. Fang : J. Zhai : J. Zhao (*)
Institute of Mental Health, the Second Xiangya Hospital,
Central South University,
139 Renmin Middle Road,
Changsha 410011 Hunan, People’s Republic of China
e-mail: fengcsu@yahoo.com.cn
M. Fang
Mental Health Center, Tongji Medical College of Huazhong
University of Science and Technology,
Wuhan, China
B. Wang
Chongqing Mental Health Center,
Chongqing, China
C. Wang
Beijing Anding Hospital Affiliated to Capital Medical University,
Beijing, China
B. Hu
Psychiatric Hospital of Jiangxi Province,
Nanchang, China
X. Sun
Mental Health Center of West China Hospital, Sichuan University,
Chengdu, China
L. Lv
Mental Hospital of Henan Province,
Xinxiang, China
Z. Lu
Shanghai Mental Health Center,
Shanghai, China
C. Ma
Guangzhou Brain Hospital,
Guangzhou, China
T. Guo
Hunan Brain Hospital,
Changsha, China
S. Xie
Nanjing Brain Hospital, Nanjing Medical University,
Nanjing, China
E. W. Twamley : H. Jin
Department of Psychiatry, University of California,
San Diego, USA
476
Results The percentage of patients discontinued treatment
within 12 months was 41.4% for chlorpromazine, 39.5% for
sulpiride, 36.7% for clozapine, 40.2% for risperidone, 39.6%
for olanzapine, 46.9% for quetiapine, and 40.2% for aripiprazole, a nonsignificant difference (p=0.717); there were no
significant differences among these seven treatments on
discontinuation due to relapse, intolerability, patient decision,
or nonadherence (all p values≥0.260). Extrapyramidal
symptoms were more prominent in chlorpromazine and
sulpiride treatment groups. Anticholinergic side effects were
most common with clozapine and chlorpromazine. Weight
gain was most common with olanzapine and clozapine.
Conclusions The efficacy of seven antipsychotic medications for the maintenance treatment appeared similar in
early-stage schizophrenia. With regard to the high dropout
rate and side effects, special programs are needed to keep
efficacy and safety of antipsychotics maintenance treatment
for schizophrenia with early stage
Keywords Antipsychotic . Schizophrenia . Safety
Introduction
Treatment of schizophrenia usually involves the long-term
administration of antipsychotic drugs. However, long-term
therapy with antipsychotics is generally associated with the
lack of efficacy, poor patient compliance, and a range of
adverse effects including acute extrapyramidal symptoms,
tardive dyskinesia, weight gain, and sedation. These
adverse effects can interfere with long-term adherence to
maintenance drug therapy (Lieberman et al. 2003a).
Atypical antipsychotic drugs have been proven lower risk
of extrapyramidal symptoms, but higher risk of metabolic
adverse events (Marder et al. 2003;Leucht et al. 2009a, b).
The effectiveness of long-term therapy with typical and
atypical antipsychotics in schizophrenia is not well understood, but some recent studies had sought to provide
objective evidence in real-world settings. One study
comparing haloperidol and risperidone in stable outpatients
found advantages in preventing relapse for risperidone
(Csernansky et al. 2002). The Schizophrenia Outpatient
Health Outcomes study shows that patients on clozapine
and olanzapine have a lower risk of relapse and patients on
olanzapine have a higher chance of remission than typical
antipsychotics (Haro et al. 2006). Results of the Clinical
Antipsychotic Trials of Intervention Effectiveness (CATIE)
have been found no differences in drug discontinuation
rates between typical and atypical drug in chronic schizophrenia patients (Lieberman et al. 2005). Comparison of
atypicals in first episode of psychosis found atypical
antipsychotics (quetiapine, risperidone, and olanzapine)
had equal effectiveness in first episode schizophrenia
Psychopharmacology (2011) 216:475–484
(McEvoy et al. 2007). The new result of European FirstEpisode Schizophrenia Trial showed all atypical antipsychotics better than haloperidol in loss of retention on drug
(Kahn et al. 2008).
Schizophrenic patients require long-term antipsychotic
maintenance treatment, but studies of maintenance treatment with antipsychotic drugs in the early stage of stable
schizophrenia are scarce, especially some typical antipsychotics (e.g., chlorpromazine and sulpiride) and clozapine
used widely in developing countries(Si et al. 2004; Mao et
al. 2007). Patients with early-stage schizophrenia are likely
to be more sensitive to drugs than are those with chronic
ones. Moreover, trials of drugs in chronic patients were
usually conducted in highly selected samples, so findings
have no external validity.
We undertook an open-label, prospective observational,
multicenter study to determine if any of seven antipsychotics
(chlorpromazine hydrochloride, sulpiride, clozapine, risperidone, olanzapine, quetiapine fumarate, and aripiprazole)
maintenance treatment was more effective in stable outpatients with schizophrenia or schizophreniform disorder, and
whether atypical antipsychotics had an advantage over typical
antipsychotics. We selected these antipsychotics because over
90% of schizophrenia patients in China were prescribed one
of these antipsychotics (Si et al. 2004).
Methods
Participants
The study was conducted between January 2005 and
October 2007 at ten clinical sites in China (six university
clinics and four province mental health agencies). Study
participants were enrolled from outpatient psychiatric
clinics and included in the study if they met the following
criteria: (1) were age 16–50 years; (2) met the Diagnostic
and Statistical Manual, Fourth Edition (DSM-IV) criteria
for schizophrenia or schizophreniform disorder within the
past five years, as assessed with the Structured Clinical
Interview for DSM-IV, Research Version; (3) lived with
family members who could be involved in the patients’
care; (4) had relatively stable improvement (Positive and
Negative Syndrome Scale (PANSS) (Kay et al. 1987) total
scores were≤60); (5) treated with only one of the following
seven oral antipsychotics: chlorpromazine, sulpiride, clozapine, risperidone, olanzapine, quetiapine, or aripiprazole for
at least 8 weeks, provided that the dose had remained stable
during the 4 weeks before screening. Patients were
excluded if they were: (1) prescribed two or more
antipsychotics or long-acting injectable antipsychotics; (2)
had treatment-refractory illness according to Kane’s criteria
(Kane et al. 1988), as evidenced by continued psychosis
Psychopharmacology (2011) 216:475–484
despite two previous trials of conventional neuroleptics at
dosages of at least 1,000 mg of chlorpromazine equivalents
a day for at least 6 weeks; (3) pregnant or breastfeeding; (4)
diagnosed with a serious and unstable medical condition; or
(5)participating in other therapy programs.
Study design
This was a 12-month open-label, naturalistic, flexible-dose,
multicenter study of antipsychotic medications used for
treatment of early course of schizophrenia. Patients initiated
or switched to one of study antipsychotic drugs before
screening were potential candidates for the study. If patients
entered a stabilization period and met our study criteria,
they were invited to participate in this 12-month maintenance treatment study.
The study was approved by the institutional review
board at each site, and a written informed consent was
obtained from the patients and their legal guardians.
Interventions
Since all patients were on maintenance treatment, we
encouraged clinicians to try to keep patients on the same
medication for 3 to 6 months in order to gauge treatment
efficacy and minimize early discontinuation. However,
medications could be changed at any time during the
course of the study if the change was clinically warranted.
If a patient’s medication was stopped or switched, patients
were classified as discontinued and terminated from the
study. No further assessments were required for these
patients. During the 12-month follow-up study, the daily
doses of antipsychotics was set: chlorpromazine hydrochloride 200 to 800 mg, sulpiride 200 to 1,200 mg, clozapine
100 to 450 mg, risperidone 1.5 to 6 mg, olanzapine 5 to
20 mg, quetiapine fumarate 200 to 750 mg, and aripiprazole
5 to 30 mg. Mood stabilizers, benzodiazepines, antidepressants, and anticholinergic medications were permitted, and
daily doses of all medications were recorded throughout the
study.
Outcome measures
All subjects were assessed monthly by the study psychiatrists and every 2 weeks by a research assistant who had
instructions to contact the psychiatrist if medication
discontinuation, relapse or other problems were suspected.
The primary outcome measure was rate of treatment
discontinuation or change and time to treatment discontinuation. Our criteria for treatment discontinuation or change
were somewhat broader than those of the CATIE study
(Lieberman et al. 2005) and included: (1) clinical relapse/
hospital admission, (2) patient’s refusal or lost to follow-up,
477
(3) noncompliance or changing initial antipsychotic, and (4)
intolerability. When investigators recorded more than one
reason for discontinuation, we ranked the reasons: clinical
relapse/hospital admission, intolerability, noncompliance or
changing initial antipsychotic, and other reasons.
Clinical relapse was defined by any one of the following
(Csernansky et al. 2002): (1) psychiatric hospitalization, (2)
an increase in the level of psychiatric care (e.g., from clinic
visits to day treatment) and a 25% or more increase in the
PANSS total score (or 10 points if the initial score was 40
or less), (3) a Clinical Global Impressions (CGI) Scale
score of “much worse” or “very much worse” (Guy 1976a),
(4) deliberate self-injury, (5) emergence of clinically
significant suicidal or homicidal ideation, or (6) violent
behavior resulting in significant injury to another person or
significant property damage.
Secondary outcomes further assessed treatment effectiveness by measuring symptom severity (PANSS) and
CGI, insight (Insight and Treatment Attitudes Questionnaire (ITAQ) McEvoy et al. 1989), treatment adherence
(appointment compliance), and social function on the
Global Assessment Scale (GAS) Guy 1976b; Endicott et
al. 1976).The physical examination and the effect of
antipsychotic treatment on weight gain were recorded
regularly. The tolerability and adverse events was assessed
by Treatment Emergent Symptom Scale (Guy 1976c) and
the Simpson–Angus Extrapyramidal Signs Scale (Simpson
and Angus 1970).
Data collected at baseline and after 3, 6, 9, and
12 months of study participation, as well as the
treatment discontinuation.
All interviewers trained and received reassessments of
inter-rater reliability based on videotaped demonstration
interviews. Agreement among the raters was high for the
PANSS, CGI (Pearson’s correlation coefficient=0.78 to
0.86) at baseline, and every 6 months.
Statistical analyses
All analyses were conducted with the Statistical Package
for Social Sciences, version 15.0 (SPSS Inc, Chicago,
Illinois). Assuming a treatment discontinuation rate at
12-month follow-up, of 50% in patients receiving firstgeneration antipsychotic drugs and 40% in patients receiving second-generation antipsychotic drugs, 136 patients per
treatment group were needed, on the basis of a two-tailed
test with α=5% and 1-β=80%. Therefore, we planned to
enroll 150 patients per group. The seven treatment regimens
were compared at baseline for continuous parameters with a
six degree of freedom analysis of variance (ANOVA) test.
Groups were compared for baseline categorical outcomes
with Pearson’s Chi-square (χ2) test, Kruskal–Wallis H test,
or Fisher’s exact test.
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Psychopharmacology (2011) 216:475–484
The primary outcome measure was analyzed using
Pearson’s χ2 test and Kaplan–Meier survival analysis
(comparing the treatment groups with a log-rank test),
considering all eligible patients.
The continuous (secondary) outcome measures used the
intention-to-treat population included all eligible patients
with at least one follow-up test. Missing data of patients
discontinuing were replaced by the last-observation carriedforward. Changes within groups were analyzed using
Within-sample t tests (paired t tests). Treatment regimens
were compared for change from baseline for PANSS, CGIS, ITAQ, and GAS total scores at 12 months using an
analysis of covariance (ANCOVA) with adjustment for the
baseline value. Other categorical outcomes were compared
with the use of Pearson’s χ2 test or Fisher’s exact test.
Partitions of χ2 methods were performed comparing the
data between each treatment group if overall χ2 p value
were more than 0.05. We adjusted the alpha levels in the
following way, α*=α/[k(k-1)/2+1]=0.05/[7*(7–1)/2+1]=
0.0023, according to Brunden (Brunden 1972) and Bortz
(Bortz et al. 1990).
Results
The mean age of eligible subjects was 26.1 years
(SD, 7.7), 45.6% were female, and most patients had a
diagnosis of schizophrenia (85.0%; Table 1). There were
no significant differences among treatment groups in age,
sex, education, marital status, diagnostic composition,
number of episodes, duration of illness, psychopathology
scores, or duration of study drug treatment before
screening (all p values≥0.059). Differences in socioeconomic status among groups was found (p
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