A factor analytic comparison of three commonly used depression scales (HAMD, MADRS, BDI) in a large sample of depressed inpatients.

BACKGROUND: Quantifying depression mainly relies on the use of depression scales, and understanding their factor structure is crucial for evaluating their validity. METHODS: This post-hoc analysis utilized prospectively collected data from a naturalistic study of 1014 inpatients with major depression. Confirmatory and exploratory factor analyses were performed to test the psychometric abilities of the Hamilton Depression Rating Scale, the Montgomery Asberg Depression Rating Scale, and the self-rated Beck Depression Inventory. A combined factor analysis was also conducted including all items of all scales. RESULTS: All three scales showed good to very good internal consistency. The HAMD-17 had four factors: an "anxiety" factor, a "depression" factor, an "insomnia" factor, and a "somatic" factor. The MADRS also had four factors: a "sadness" factor, a neurovegetative factor, a "detachment" factor and a "negative thoughts" factor, while the BDI had three factors: a "negative attitude towards self" factor, a "performance impairment" factor, and a "somatic" factor. The combined factor analysis suggested that self-ratings might reflect a distinct illness dimension within major depression. CONCLUSIONS: The factors obtained in this study are comparable to those found in previous research. Self and clinician ratings are complementary and not redundant, highlighting the importance of using multiple measures to quantify depression.

Design and outcome measures of LAVENDER, a phase 3 study of trofinetide for Rett syndrome.

INTRODUCTION: Rett syndrome (RTT) is a debilitating neurodevelopmental disorder with no approved treatments. Trofinetide is a synthetic analog of glycine-proline-glutamate, the N-terminal tripeptide of insulin-like growth factor 1. In a phase 2, placebo-controlled trial in 82 females with RTT aged 5-15 years, a significant (p ≤ 0.042) improvement over placebo was observed with the highest trofinetide dose (200 mg/kg twice daily [BID]) on three measures: Rett Syndrome Behaviour Questionnaire (RSBQ), Clinical Global Impression-Improvement (CGI-I), and RTT-Clinician Domain Specific Concerns-Visual Analog Scale (RTT-DSC-VAS). Trofinetide was well tolerated at all doses (50, 100, and 200 mg/kg BID). A phase 3 trial utilizing disease-specific and novel scales was designed to investigate the efficacy and safety of trofinetide in girls and women with RTT. METHODS: This 12-week, double-blind, randomized, placebo-controlled study (LAVENDER; NCT04181723) will evaluate trofinetide in 187 females, aged 5-20 years, with RTT. Co-primary endpoints are the RSBQ and CGI-I scales. Clinical domains of the CGI-I include communication, ambulation, hand use, seizures, attentiveness, and social (eye contact) and autonomic (breathing) aspects. Secondary endpoints will leverage four novel RTT-specific clinician ratings (derived from the RTT-DSC-VAS) of hand function, ambulation, ability to communicate, and verbal communication, and existing scales, to evaluate other core symptoms of RTT, quality of life and caregiver burden. A 40-week, open-label extension study will follow. DISCUSSION: This study was designed using disease-specific scales optimized to demonstrate changes in core symptoms of RTT and may provide the first phase 3 data demonstrating drug efficacy in individuals with RTT. TRIAL REGISTRATION: Clinicaltrials.govNCT04181723.

Comparison of Different Adherence Measures in Adolescent Outpatients with Depressive Disorder.

PURPOSE: Adolescent depression can have a chronic course; hence, the importance of adherence to antidepressant medication for successful treatment outcomes is emphasized. This study aimed to examine different adherence measures and identify clinical factors that influence adherence in adolescent depression. PATIENTS AND METHODS: A prospective study was conducted for patients diagnosed with depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition from outpatient psychiatric settings at Korea University Medical Center, Guro Hospital. Patient demographics were obtained from a questionnaire, interview, and review of chart records. Adherence was assessed by four methods (Medication Event Monitoring System [MEMS], pill count, clinical rating scale, and patient's self-report). The Toronto Side Effect Scale was used to evaluate side effects, and specific depressive symptoms were assessed using the Hamilton Rating Scale for Depression and Childhood Depression Inventory-Korean version. The Multidimensional Scale of Perceived Social Support was administered to analyze social support, and the Parenting Stress Index-Short Form was used to evaluate parental stress levels. We used concordance correlation analysis to evaluate the relationship among the four adherence measures and the relationship between adherence level and clinical factors. RESULTS: Overall, the study enrolled 48 outpatients (mean age 16.33±1.93 years). The mean duration of illness was 1.27±2.17 years. Adherence rates for MEMS, clinician rating scale, pill count, and self-report after conversion to dichotomous measures were 67.5%, 48.9%, 60.0%, and 56.3%, respectively. Only the duration of illness remained significantly correlated with MEMS (r = 0.510, p =0.001). CONCLUSION: Pill count exhibited a higher degree of agreement with MEMS adherence than the other two adherence measures, possibly indicating that pill count may be a considerably reliable measure of adherence. Furthermore, MEMS adherence was positively correlated with disease duration, suggesting that the longer the duration of illness, the higher the adherence.

Disagreement and factors between symptom on self-report and clinician rating of major depressive disorder: A report of a national survey in China.

BACKGROUND: Measurement-based care (MBC) is a popular strategy of clinical management for patients with major depressive disorder (MDD). The consistency of self-report and clinical measurements is of importance, but whether individual symptom severity is in agreement for both self-report and clinician rating in MDD has not been comprehensively tested. This study aimed to test whether individual symptom severity of MDD was in agreement between self-report and clinician rating, and to explore factors affecting the agreement. METHODS: In the National Survey on Symptomatology of Depression (NSSD) of China, 3275 patients with a major depressive episode were evaluated by both self-report and a clinician-rated version of 62 questions. RESULTS: On average, 59% of all patients reached absolute agreement with their research clinicians. Among all questions, 73% returned with moderate positive strength of correlation, followed by 27% with low positive correlation. In 77% of the total questions, there was a tendency to rate higher in the self-report version compared with the clinician-rated version. After classifying the symptoms by six major domains, it was found that patients and clinicians showed more consistent answers in history and somatic questions (81% and 65% reached agreement), and that there were more differences in mood, energy, and anxiety questions (up to 56% in full agreement). "Outpatient", "high financial status", "poor working condition", and "high education level" were found to be significant positive predictors for patients rating higher than clinicians or patients and clinicians reaching agreement as opposed to clinicians rating higher than patients. LIMITATIONS: The cross-sectional nature of our study undermines the interpretation of the results across the MDD treatment course. CONCLUSIONS: It is sufficient to use the self-report version of a questionnaire to screen, monitor, and detect remission for MDD symptoms. Complete assessment of depression severity should take both clinician-rated scales and self-reported measures into consideration. Factors other than source of admission, financial status, working condition, and education level should be further investigated for the discrepancy between self-report and clinician rating.

Comparison of self-report and clinician-rated schizotypal traits in schizotypal personality disorder and community controls.

Given the common use of self-report questionnaires to assess schizotypy in personality pathology and schizophrenia research, it is important to determine the concordance between self-report and clinician ratings. 250 individuals with schizotypal personality disorder (SPD) and 116 community controls (CTR) were assessed on schizotypal traits using a clinical interview, the Structured Interview for DSM-IV Personality disorders (SIDP), and a self-report questionnaire, the Schizotypal Personality Questionnaire (SPQ). Ordinal logistic regressions examined concordance between self-reported and clinician-rated scores in CTR and SPD separately. Analyses of variance examined how the SPQ performed on differentiating between CTR with low schizotypy, CTR with high schizotypy, and SPD. For both CTR and SPD, higher SPQ subscale scores were significantly associated with higher clinician ratings on the respective SIDP items for the Ideas of Reference, Magical Thinking, Unusual Perceptual Experience, Suspiciousness, and Social Anxiety items, but not the Odd Speech or Limited Affect items. Higher SPQ subscale scores for Odd Behavior and Lack of Close Friends were significantly associated with the clinician-rated SIDP item scores in CTR but not SPD. CTR with low schizotypy scored lower on all SPQ subscales than CTR with high schizotypy, who did not differ from SPD. Self-report ratings are concordant with clinician ratings for positive schizotypal traits, whereas certain disorganization and interpersonal traits are not, particularly for individuals with SPD. The SPQ can differentiate between high and low schizotypy controls, but not between high schizotypy controls and individuals with SPD. Assessment of schizotypal traits should include both self-report questionnaires and clinician ratings.

Reliability and validity of the self-report version of the apathy evaluation scale in first-episode Psychosis: Concordance with the clinical version at baseline and 12 months follow-up.

Negative symptoms have traditionally been assessed based on clinicians' observations. The subjective experience of negative symptoms in people with psychosis may bring new insight. The Apathy Evaluation Scale (AES) is commonly used to study apathy in psychosis and has corresponding self-rated (AES-S) and clinician-rated (AES-C) versions. The aim of the present study was to determine the validity and reliability of the AES-S by investigating its concordance with the AES-C. Eighty-four first-episode (FEP) patients completed the shortened 12-item AES-S and AES-C at baseline (T1) and 12 months (T2). Concordance was studied by degree of correlation, comparison of mean scores, and change and difference between diagnostic groups. The Positive and Negative Symptom Scale (PANSS) was used to study convergent and discriminative properties. High concordance was found between AES-S and AES-C at both T1 and T2 regarding mean values, change from T1 to T2, and the proportion with high levels of apathy. Both versions indicated high levels of apathy in FEP, while associations with PANSS negative symptoms were weaker for AES-S than AES-C. Controlling for depression did not significantly alter results. We concluded that self-rated apathy in FEP patients is in concordance with clinician ratings, but in need of further study.

Are self-report scales as effective as clinician rating scales in measuring treatment response in routine clinical practice?

OBJECTIVE: Recent treatment guidelines have suggested that outcome should be measured in routine clinical practice. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, we compared three self-report scales of depressive symptoms and the two most widely used clinician administered scales in treatment studies in their sensitivity to change and evaluation of treatment response in depressed patients treated in routine practice. METHODS: At baseline and 4-month follow-up 153 depressed outpatients with DSM-IV MDD completed the Clinically Useful Depression Outcome Scale (CUDOS), Quick Inventory of Depressive Symptomatology-Self-report version (QIDS-SR), and Patient Health Questionnaire (PHQ-9). The patients were rated on the 17-item Hamilton Depression Rating Scale (HAMD) and the Montgomery-Asberg Depression Rating Scale (MADRS). On each scale treatment response was defined as a 50% or greater reduction in scores from baseline. RESULTS: While there were some differences in the percentage of patients considered to be responders on the different scales, a large effect size was found for each scale, with little variability amongst the scales. The level of agreement between the three self-report scales and the clinician rating scales was approximately the same LIMITATIONS: The present study was conducted in a single clinical practice in which the majority of the patients were white, female, and had health insurance. DISCUSSION: When measuring outcome in clinical practice the magnitude of change in depressive symptoms is as great on self-report scales as on clinician rating scales.