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Is the psychotic depression assessment scale a useful diagnostic tool?: The CRESCEND study Seon-Cheol Park, Joonho Choi, Jae-Min Kim, Tae-Youn Jun, Min-Soo Lee, Jung-Bum Kim, Hyeon-Woo Yim, Yong Chon Park

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S0165-0327(14)00276-6 http://dx.doi.org/10.1016/j.jad.2014.05.004 JAD6749

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Journal of Affective Disorders

Received date: 31 March 2014 Revised date: 22 April 2014 Accepted date: 2 May 2014 Cite this article as: Seon-Cheol Park, Joonho Choi, Jae-Min Kim, Tae-Youn Jun, Min-Soo Lee, Jung-Bum Kim, Hyeon-Woo Yim, Yong Chon Park, Is the psychotic depression assessment scale a useful diagnostic tool?: The CRESCEND study, Journal of Affective Disorders, http://dx.doi.org/10.1016/j. jad.2014.05.004 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Is the Psychotic Depression Assessment Scale a Useful Diagnostic Tool? : The CRESCEND Study

Seon-Cheol Parka,b, Joonho Choib,c, Jae-Min Kimd, Tae-Youn June, Min-Soo Leef, Jung-Bum Kimg, Hyeon-Woo Yimh, Yong Chon Parkb,c*

a

Department of Psychiatry, Yong-In Mental Hospital, Yongin, Republic of Korea

b

Institute of Mental Health, Hanyang University, Seoul, Republic of Korea

c

Department of Psychiatry, College of Medicine, Hanyang University, Guri Hospital, Guri,

Republic of Korea d

Department of Psychiatry, Chonnam National University School of Medicine, Gwangju,

Republic of Korea e

Department of Psychiatry, College of Medicine, Catholic University of Korea, Seoul,

Republic of Korea f

Department of Psychiatry, College of Medicine, Korea University, Seoul, Republic of Korea

g

Department of Psychiatry, Keimyung University School of Medicine, Daegu, Republic of

Korea h

Department of Preventive Medicine, College of Medicine, Catholic University of Korea,

Seoul, Republic of Korea

*Corresponding

author.

Tel:

+82-31-560-2273;

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+82-31-554-2599;

Address:

Department of Psychiatry, Hanyang University Guri Hospital 249-1, Gyomun-dong, Guri 471701, Korea

E-mail addresses: [email protected] (P. Seon-Cheol), [email protected] (C. Joonho), [email protected] (K. Jae-Min), [email protected] (J. Tae-Youn), [email protected] (L. Min-Soo), [email protected] (K. Jung-Bum), 1

[email protected] (Y. Hyeon-Woo), [email protected] (P. Yong Chon)

Running head: Psychotic Depression Assessment Scale Word count (original article): 3,703 Table count: 3 Figure count: 2

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Abstract Background: The Psychotic Depression Assessment Scale (PDAS) has been validated as a method of assessing the severity and treatment outcomes of psychotic depression (PD). We aimed to compare the results of the PDAS in PD and non-psychotic depression (non-PD) patients and validate the PDAS as a diagnostic tool for PD. Methods: We included 53 patients with PD and 441 with non-PD who participated in the Clinical Research Center for Depression study in South Korea. In addition to the PDAS, psychometric tools including the HAMD17, HAMA, BPRS, CGI-S, SOFAS, SSI-Beck, WHOQOL-BREF, AUDIT, and FTND were used to assess, respectively, depression, anxiety, overall symptoms, global severity, social functioning, suicidal ideation, quality of life, alcohol use, and nicotine use. Results: After adjusting for age and total HAMD17 score, PD patients had higher scores for depressive mood, hallucinations, unusual thought content, suspiciousness, blunted affect, and emotional withdrawal on the PDAS and higher total scores on the SSI-Beck than nonPD patients. Binary logistic regression identified hallucinatory behavior and emotional withdrawal as predictors of PD. Receiver operating characteristic analysis showed that emotional withdrawal could be used to differentiate psychotic from non-psychotic depression. Limitations: The inter-rater reliability for psychometric assessments was not evaluated. Conclusions: In addition to assessing the severity and treatment outcomes of PD, PDAS can help in the diagnosis of PD.

Keywords: Psychotic Depression Assessment Scale (PDAS); psychotic depression (PD); hallucinatory behavior; emotional withdrawal; differential diagnosis

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1. Introduction Psychotic depression (PD) denotes the clinical condition of depression accompanied by psychotic symptoms. Previously, the commonly-accepted ‘severity–psychosis’ hypothesis proposed that the psychotic features in PD were secondary to the severity of depression, and PD was classified as a subtype of severe depression (Lichtenberg and Belmarker, 2010; Østergaard et al., 2012, a, b; Schatzberg and Rothschild, 1992). According to the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association, 1994), the specifier “with psychotic features” was only used in connection with severe major depression. However, the severity of depression alone is not sufficient to explain the occurrence of psychotic symptoms. In addition to psychosis and severity of depression, there are other features that differentiate PD from non-psychotic depression (non-PD), including feelings of guilt and suicidal ideation or suicide attempts. Psychotic and non-psychotic depressions have also been associated with different underlying mechanisms, clinical progress and prognoses, as well as responses to pharmacological treatment (Østergaard et al., 2012, a, b; Schatzberg and Rothschild, 1992). Østergaard et al. (2013, a) reported a case where a patient experienced the same delusional theme over 13 episodes of PD, and they suggested that PD can be a stable phenotype. An increasing number of psychiatrists believe that PD should be classified as an independent disease entity from depressive disorders (Coryell et al., 1994; Østergaard et al., 2012, a, b; Schatzberg and Rothschild, 1992). The DSM-5 (American Psychiatric Association, 2013) recently rejected the severity–psychosis hypothesis. In this latest edition, the specifier “with psychotic features” is permitted in connection with any depressive episode regardless of its severity, and the statement that PD mood-congruent psychotic features are more common than mood-incongruent psychotic features has been removed. The Psychotic Depression Assessment Scale (PDAS) is a psychometric method developed to assess the severity and treatment outcomes of PD (Østergaard et al., 2014, a, b). 4

Although the Hamilton Depression Rating Scale (HAMD17) (Hamilton, 1960) has been frequently used for this purpose in clinical trials, the clinical and psychometric properties it uses to asses PD have not been validated. Moreover, the HAMD17 does not cover the psychotic features and a wide range of other manifestations of PD. The PDAS represents the various aspects of PD more comprehensively, and has been validated as a psychometric tool. It consists of six items from the Hamilton Melancholia Subscale (HAMD6) (Bech et al., 1975, 1981, 2011): depressed mood, guilt feelings, work and activities, psychomotor retardation, psychic anxiety, and general somatic symptoms, and five items from the Brief Psychiatric Rating Scale (BPRS) (Overall and Gorham, 1962): hallucinatory behavior, unusual thought content, suspiciousness, blunted affect, and emotional withdrawal. The HAMD6 items are a subset of HAMD17 known as the ‘depression ruler’. Despite its utility and ready availability, the PDAS has not been investigated extensively, and the symptoms that differentiate between PD and non-PD are not yet known. The Clinical Research Center for Depression (CRESCEND) study (Kim et al., 2011, a, b; Seo et al., 2014, a, b; Yang et al., 2012) was the first large, prospective, observational clinical study of a nationwide sample of patients with depressive disorders in Korea assessed by employing psychometric scales. Using patient data from this study, we aimed to compare the demographic and clinical features of patients with PD and non-PD with the help of PDAS and other assessment tools, in order to identify the distinguishing characteristics and predictors of PD.

2. Materials and methods As described elsewhere (Kim et al., 2011, a, b; Seo et al., 2014, a, b; Yang et al., 2012), from January 2006 to August 2008, 1183 patients with depressive disorders (major depressive disorder, dysthymic disorder, or other non-specified depressive disorders) who were beginning treatment for first-onset or recurrent depression were enrolled into the CRESCEND study taking place at 18 centers across South Korea, including 16 university5

affiliated hospitals and two general hospitals. These patients gave their informed consent prior to participation. The study protocol and consent forms were approved by all relevant Institutional Review Boards (IRBs). All demographic and clinical data were collected and evaluated by trained and certified research coordinators under the supervision of clinical psychiatrists at each of the regional centers. Data collection was managed by the Department of Preventive Medicine of the Catholic University College of Medicine in Seoul, Korea.

2.1.

Definition of psychotic depression

Following Østergaard et al. (2012, b) PD was defined in our study as depression of any severity accompanied by psychotic symptoms. Based on the DSM-IV criteria (American Psychiatric Association, 1994), delusion was defined as a false and unshakeable idea or belief that is out of keeping with the patient’s educational, cultural, and social background, and hallucination was defined as a perception without an apparent stimulus that has the qualities of a real perception. Our inclusion criteria were as follows: (i) age 18 years, (ii) recorded presence or absence of psychotic symptoms, (iii) diagnosed major depressive disorder, dysthymic disorder, or other non-specified depressive disorders, and (iv) available of fully completed the HAMD17 and BPRS. Diagnoses were made by clinical psychiatrists using the DSM-IV criteria (American Psychiatric Association, 1994) and confirmed within two weeks using the Structured Clinical Interview (SCID) based on DSM-IV (First et al., 1995). We included 494 patients, 53 with PD and 441 with non-PD. In our study, the reasons for including patients with dysthymic disorder and other non-specified depressive disorders as well as major depressive disorder were as follows. From the findings of prior studies, there has been a reciprocal relationship between dysthymia and psychosis (Weiser et al., 2008; Rössler et al., 2011). Moreover, in the DSM-5 (American Psychiatric Association, 2013), the specifier “with psychotic features” has been permitted in connection with dysthymia as well as major depressive disorder regardless of levels of severity. 6

2.2.

Psychotic Depression Assessment Scale

As proposed by Østergaard et al. (2014, a, b), the total score on the PDAS was based on a selection of items from the HAMD17 and the BPRS. Most of the HAMD17 items were scored on a 5-point scale (0 to 4), whereas all of the BPRS items were score on a 7-point scale (1 to 7). The BPRS scores were subsequently adjusted using the formula: (BPRS score - 1) × 2/3. In addition, the score for the general somatic symptoms item in the HAMD17 was multiplied by 2.

2.3.

Psychometric assessments

Psychometric scales including the HAMD17 (Hamilton, 1960), the HAMD6 (Bech et al., 1975, 1981, 2011), the BPRS (Overall and Gorham, 1962), the Hamilton Anxiety Rating Scale (HAMA) (Hamilton, 1959), the Clinical Global Impression of Severity scale (CGI-S) (Guy, 1976), and the Social and Occupational Functioning Assessment Scale (SOFAS) (Goldman et al., 1992) were used to evaluate, respectively, depressive symptoms, core symptoms of depression, anxiety symptoms, positive and negative symptoms, global severity, and social and occupational functioning. In addition positive symptoms were assessed using the summed score of the five BPRS items, conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and disorientation. Similarly, negative symptoms were additionally assessed using the summed score of the three BPRS items, emotional withdrawal, motor retardation, and blunted affect (Lachar et al., 2001). All the research coordinators received training twice a year, with a formal consensus meeting to determine the correct application of the assessment instruments. Additional self-reported questionnaires, including the Scale for Suicidal Ideation (SSI-Beck) (Beck et al., 1979), the WHO Quality of Life questionnaire–abbreviated version (WHOQOL-BREF) (The WHOQOL Group, 1998), the Alcohol Use Disorder Identification Test (AUDIT) (Saunders et al., 1993), and the Fagerström Test for Nicotine Dependence (FTND) (Heatherton et al., 1991) were 7

used to evaluate, respectively, the severity of current suicidal ideation, the quality of life, alcohol use, and nicotine use. All scales had been formally translated into Korean and confirmed as valid and reliable in Korean populations (Joe et al., 2009; Lee et al., 2006; Yi et al., 2005). Higher scores on the HAMD17 (Hamilton, 1960), HAMD6 (Bech et al., 1975, 1981, 2011), BPRS (Overall and Gorham, 1962), HAMA (Hamilton, 1959), CGI-S (Guy, 1976), SSIBeck (Beck et al., 1979), AUDIT (Saunders et al., 1993) and FTND (Heatherton et al., 1991) scales represent more severe individual symptoms, while lower scores on the SOFAS (Goldman et al., 1992) and WHOQOL-BREF (WHOQOL Group, 1998) indicate poorer function and lower quality of life.

2.4.

Statistical analysis

The demographic and clinical characteristics and the assessment scale scores of patients with PD and non-PD were compared using the independent t-test for continuous variables and the 2 test for discrete variables. A binary logistic regression model was fitted to identify predictors of PD after adjusting for age and total score on the HAMD17. In this model, the PD group was the dependent variable, and the non-PD group was the reference category. Clinical variables that were significantly different between the two groups were defined as covariates. A goodness-of-fit test was used to select and validate the final model. To reduce the familywise error rate due to multiple comparisons, statistical significance was set at P