Vieta E, Jiménez Arriero MA, Arce Cordón R, Cobaleda S

Vieta E, Jiménez Arriero MA, Arce Cordón R, Cobaleda S

Functional, Social and Labour Impact of Depressive
Symptoms in Clinically Stable Patients (SIN-DEPRES STUDY)
16th European Congress of Psychiatry Nice, France 5-9 April 2008
BIPOLAR UP-TO-DATE
E.Vieta1, M. A. Jimenez-Arriero2, R. De Arce Cordón3, S. Cobaleda4 for the SIN-DEPRES study group of investigators.
Bipolar Disorder Programme. Institut Clínic Neurociències. Hospital Clinic, IDIBAPS, CIBERSAM,University of Barcelona, Barcelona Stanley Foundation Center. Barcelona, Spain, 2 Psychiatry Department.
Hospital 12 de Octubre,CIBERSAM, Madrid, Spain 3 Bipolar Disorder Unit. Hospital Universitario Puerta de Hierro. Madrid, Spain4 Medical Department. GlaxoSmithKline. Madrid. Soain
Cross-sectional, prospective, 16-week study of a cohort
of BD patients. A control group was recruited as healthy
subjects (HS) to test the validity of the symptoms
recorded. Clinical stability of BD was assessed at
baseline and at week 16, with the Clinical Global
Impression scale for BD (CGI-BP-M). Depressive
symptoms were assessed at baseline with the Hamilton
Depression Rating Scale (HDRS-17), the MontgomeryAsberg Scale (MADRS) and the self-applied instrument
Center for Epidemiologic Studies-Depression Scale
(CES-D). Functional status was evaluated with the Social
and the Occupational Functioning Assessment Scale
(SOFAS) and Social Adaptation Self-Evaluation Scale
(SASS).
CLINICAL PROFILE
261
35.3

Rapid cycling
126
17.1
Mean
SD
29.7
11.8
 Time of disease evolution (age at first episode)
 Number of episodes per year
1.5
1.1
 Duration of most recent episode (days)
74.1
70.3
n
%
438
295
59.3
39.9
 Education Completed
 No studies completed
 Basic Education
 High School
 University
47
279
236
162
1.9
37.8
31.9
21.9
CLINICAL SUB-POPULATIONS
Total Sample of Bipolar Disorder Patients
Bipolar Disorder (BD)
Disorder Type
BD Type I
BD Type II
Evolutive Profile
Rapid Cycling
Follow up at 16-week
 Type of most recent episode

Depressive type (296.5x)
377
51.8

Manic type (296.46)
184
24.9

Hypomanic type (296.40)
127
17.2

Mixed type (296.6x)
46
6.2
Assessments according to study protocol
visits
DEPRESSIVE SYMPTOMATOLOGY DURING THE STUDY
CLINICIANS’ ASSESSMENT
Figure 1
Depressive Symptoms
Assessed by the HDRS-17
Depressive Symptoms
Measured by MADRS
Lower Cut Off Score Described for
Mild Depression (HDRS 7)
50
45
40
35
30
25
20
15
10
3,7
Basal
60
55
50
45
40
35
30
25
20
15
10
5
0
5,3
4,9
Basal
CLINICIANS’ ASSESSMENT
Study Visits
16 Week
Figure 4
Depressive
Symptoms collected from Self
Assessment by the CES-D
80,4
79,5
90
80
13,6
60
50
40
30
20
10
0
Basal Visit
16-week
60
55
50
45
40
35
30
25
20
15
10
5
0
Study Visits
Study Visits
537
202
72.7
27.3
126
17.1
663
89.7
Higher Cut Off Score Defined in the Sudy for Social Maladjustment
(SASS<25)
70
Basal
100
Social Adaptation Self-Assessment
Scale (SASS)
Cut Off Score Defined in the Study for Moderate Disability
Lower Cut Off Score Defined for a possible
positive case for depression (CES-D >15)
15,2
739
Figure 5
100
60
55
50
45
40
35
30
25
20
15
10
5
0
%
PATIENT SELF-ASSESSMENT
Social-Labour Functioning Assessment
(SOFAS)
Figure 3
Lower Cut Off Score Defined for Mild
Depression (MADRS 7 or 9)
N
FUNCTIONAL, SOCIAL AND LABOUR IMPACT
PATIENT SELFASSESMENT
Figure 2
0
 Based on clinicians’ ratings in stable patients, 6.1% of
these, 95% CI 4.5 – 8.1 showed both mild depression
on HRDS scores and difficulties on social functioning.
 The presence of depressive symptoms was related to
a negative impact on social-labour functioning and on
social adjustment. The highest correlation coefficients
were seen between SOFAS and MADRS (r= -0.54,
p<0.0001) and between SASS and CES-D (r=-0.47,
p<0.0001).
%
Seasonal profile
5
 Type of most recent episode. Manic episode
showed a lower association with high HRDS
scores. For BD patients with a previous manic
episode, basal HDRS scores were 0.86 points
lower (p<0.0001).
n

 Associated factors to depressive symptoms at baseline
were:
 Time since last episode that showed an inverted
relationship with baseline HDRS total score
(p<0.0001). For each month elapsed prior to
baseline assessment a reduction of 0,04 points
was associated on HDRS total score.
 Gender
 Women
 Men
 Clinical course
RESULTS
 In BD stable patients, depressive symptoms were
detected. Mean HDRS score was 3.7 (SD 3.1),
MADRS score 4.9 (SD 4.5) and CES-D score 15.2 (SD
9.9) (figures 2-4). BD patients also showed higher
depression scores on HDRS than HS (figures 9-10).
BD patients also showed some functional impairment
according to clinicians’ judgment, SOFAS mean score
was 79.5 (SD 12.7). SASS mean score was 37.5 (SD
7.9).
SD
13.7
%
 Age (years)
 Participation of 761 patients
from 88 Mental Health Units
from Spain
 Cross-sectional and
prospective to 16 weeks,
epidemiological,
multicentre study.
Mean
46.1
n
Total Score
METHODS
PATIENTS
DESIGN
Total Score
In bipolar disorder (BD) outpatients during stable periods,
it is important to determine the impact of depressive
symptoms on functional aspects to meet their treatment
requirements. The aim of this study is to describe the
functional impact and social adjustment in stable BD
patients, due to sub-clinical depressive symptoms.
STUDY DESIGN AND SAMPLE DESCRIPTION
Total Score
PURPOSE
Total Score
1
Basal
16-week
Relationship between HDRS and MADRS Basal Scores
37,5
37,4
Study Visits
16-week
Relationship between SOFAS scores and self-assessment SASS scores
Figure 6
SASS Total Score
HDRS-17
Basal Visit
N =736
Figure 7
r =0,79
P <0,0001
MADRS Total Score
r = 0.48
P < 0.0001
Basal Visit
N =736
Shaded areas indicates
a coincident patient
status according to both
assessment tools.
Shaded areas indicates a
coincident patient status
according to both
assessment tools.
SOFAS Total Score
MADRS
CONCLUSIONS
Depressive symptoms on BD clinically stable outpatients
may result in a decline in social-labour functionality and
social maladjustment. Self-applied tests performed during
follow-up visits provide complementary information about
patient’s mood status and daily functionality.
ACKNOWLEDGMENTS
The Sin-Depres study was funded by GlaxoSmithKline. The authors wish
to thank Sílvia Zaragoza-Domingo, Mireia Puig-Palma and Beatriz
Gancedo-Villegas
(PSYNCRO,
Neuropsychological
Research
Organization, S.L.) for their contribution to the project.
Prevalence of Depressive Symptoms with Social and Occupational Dysfunction
Definition of Prevalence
HDRS-17
HDRS-17
7 & SOFAS < 70
7 & SOFAS < 60
n
Prevalence (%)
95% CI
45 (739)
6.1
4.5 - 8.1
23 (738)
3.4
2.0 - 4.8
8 (707)
1.2
0.4 - 2.1
Social Maladjustment
HDRS-17
7 & SASS < 25
RELATIONSHIP BETWEEN DEPRESSIVE SYMPTOMS AND SOCIAL - LABOUR FUNCTIONING
REFERENCES
Correlations between Results in Depression and Social-Labour Functioning Scales - Basal Results (N = 739)
 Altshuler
Depression Scales
LL, et al. Subsyndromal depressive symptoms are associated
with functional impairment in patients with bipolar disorder: results of a
large, multisite study. J Clin Psychiatry 2006 Oct;67(10):1551-60.
Social-Labour Functioning Scales
 Judd LL, Akiskal HS. Depressive episodes and symptoms dominate the
SOFAS
longitudinal course of bipolar disorder. Curr Psychiatry Rep 2003
Dec;5(6):417-8.
 Judd
LL, et al. A prospective investigation of the natural history of the
long-term weekly symptomatic status of bipolar II disorder. Arch Gen
Psychiatry 2003 Mar;60(3):261-9.
 Nolen
WA, et al. Correlates of 1-year prospective outcome in bipolar
disorder: results from the Stanley Foundation Bipolar Network. Am J
Psychiatry 2004 Aug;161(8):1447-54.
 Post
RM, et al. Morbidity in 258 bipolar outpatients followed for 1 year
with daily prospective ratings on the NIMH life chart method. J Clin
Psychiatry 2003 Jun;64(6):680-90.
HDRS-17
MADRS
CES-D
-0.49***
-0.54***
-0.42***
 In general, the highest correlation coefficients
were obtained between the assessments made
by the same rater (the clinician or the own
patient).
 MADRS showed higher correlation coefficients
SASS (Total Score)
-0.36***
-0.42***
-0.47***
Factor 1
Functioning on the external relationships
-0.34***
-0.41***
-0.47***
Factor 2
Functioning on job and leisure
-0.37***
-0.43***
-0.49***
Factor 3
Social and intellectual interests
-0.29***
-0.36***
-0.35***
Factor 4
Familial relationships and behavior strategies
-0.33***
-0.37***
-0.45***
than HDRS-17 to Socio Laboral Functioning
measurements.
 The results indicate that depressive symptoms
contribute to patients’ socio-laboral functioning
although by themselves, do not explain the
impact of the disease on clinically stable
outpatients.
Statistical Significance: ** p < 0.001, *** p<0.0001
Depressive symptoms as expressed by the patients’ themselves (CES-D) showed a high correlation with patient’s functioning
in external relationships and in job and leisure SASS factors.
Estudio SIN-DEPRES: Agradecimientos
ANDALUCIA - Antonio Manuel González · Antonio Rodríguez ·Eloy Rodríguez · Félix Luis Reina · Francisco Compan ·Francisco Javier Alcalde · Gines Navarro · Ignacio Martínez · José Manuel Manso · José Manuel Perea ·Juan Manuel Pascual ·Leonardo Moyano · Lourdes Pacheco ·Pastora Cuevas ·Rafael de Burgos · Rafael Navarro · Raquel Carmona - ARAGÓN - Ana Isabel Calvo · Eduardo del Agua - ASTURIAS - César
Luis Sanz · José Ignacio Portilla · José Leandro Palicio · Juan Antonio Durán · Juan Carlos González · Sergio Ocio · Susana Santamarina - CASTILLA LA MANCHA - Eva Mª Murias · Lorenzo Prado · Luis Goenechea · Manuela Mollá - CASTILLA LEÓN - Angeles Alonso · Araceli Sánchez · Juan Ignacio Franch · Olga Sanz - CEUTA - Alberto Fuentes - CATALUÑA - Alfonso Rodríguez · Cristina Saez · Diego J. Palao · Eduard
Vieta · Francisco Antonio Porras · Joan Cadevall · Joan Segui · Jordi Pujiula · José Manuel Crespo · Lluís Jordà · Mª Victoria Ollés · Rafael Martin - COMUNIDAD VALENCIANA - Alfredo Cortell · José Antonio Juan · Miguel Ángel Cuquerella · Pedro Iborra · Salvador López · Sonia Vidal · Vicent Balanzá · Vicente Elvira - EXTREMADURA - Fernando Galán · Javier Busto · Luis Martín · Mª Isabel Rubio · María Ríos - GALICIA Federico Guillermo Iglesias · Julia Fraga · Leonelo Forti · Manuel Antonio Arias · Miguel Gelabert - ISLAS BALEARES - Mauro García · Olga Ibarra - ISLAS CANARIAS - Eugenio Ramón Chinea · Francisco Javier Acosta · José Antonio Gallego · José M. Brito - LA RIOJA - Ana Díaz de Cerio - COMUNIDAD DE MADRID - Alberto Cebollada · Antonio Carrillo · Consuelo de Dios · Eduardo Balbo · Elena Ezquiaga · Herminio
Martínez · Javier Ortiz · José Luis Rodríguez · José María Rodao · Mª Jesús del Yerro · Mª Jesús Muñiz · María Eulalia Jaen · Miguel Ángel Jiménez · Pilar Rojano · Rosario de Arce - MURCIA - Emilio José López · Francisco Toledo - NAVARRA - José Javier MZ. De Morentin - PAIS VASCO - Enrique Pons · Imanol Querejeta · Jesús María Ruiz · Juan Carlos Irurzun.