Multiple pain complaints in patients with major depressive disorder.

OBJECTIVE: To characterize the co-existence of multiple pain-related complaints in patients enrolled in a series of pharmaceutical company drug trials for the treatment of Major Depressive Disorder (MDD). METHOD: Pooled 'blinded' data from 2191 patients enrolled in randomized, multicenter, double-blind placebo-controlled studies for the treatment of MDD were analyzed. Painful symptoms were assessed using the seven pain symptoms subset of the Somatic Symptoms Inventory: 'Headache,' 'Pain in lower back,' 'Neck pain,' 'Pain in joints,' 'Soreness in muscles,' 'Pain in heart or chest,' and 'Pain or cramps in abdomen.' The 17-item Hamilton Depression Rating Scale (HAMD) was used to assess severity of depression. RESULTS: Of those meeting the study entry criteria (total HAMD score >or=15), 25% reported no pain complaints and 18% reported 1 pain compliant; the majority (57%) of patients reported the co-existence of multiple pain-related complaints, with 14%, 12%, 11%, 11%, 7%, and 3% of patients reporting 2, 3, 4, 5, 6 and 7 different pain symptoms, respectively. The number of pain-related symptoms experienced was moderately related to severity of depression (r = 0.35), with the most common pain symptom combinations being among headaches, lower back pain, neck pain, pain in joints, and soreness in muscles. CONCLUSIONS: This study supports pain as a component feature of MDD. The number of comorbid pain-related complaints, which generally increased as a function of depressive severity, should be considered in the diagnosis of depression, planning of treatment strategies, and measurement of treatment outcome.

Prevalence and association of somatic symptoms in patients with Major Depressive Disorder.

BACKGROUND: Painful and non-painful somatic symptoms are often reported in patients with depressive disorder. The proper identification of depression-relevant somatic symptoms is important for the accurate diagnosis of depression, development of treatment strategies and measurement of outcome. The objective of this study was to characterize the relationship between somatic symptoms and depression in patients diagnosed with Major Depressive Disorder (MDD), using data from randomized drug trials carried out by a pharmaceutical company. METHODS: Pooled 'blinded' data from 2191 patients enrolled in randomized, multicenter, double-blind placebo-controlled studies for the treatment of MDD were analyzed. Somatic symptoms were assessed using the Somatic Symptoms Inventory (SSI) and the Hamilton Depression Rating Scale (HAMD) was used to assess symptoms of depression. RESULTS: The most common somatic symptom reported by patients with MDD was 'feeling fatigued, weak, or tired all over', with 78% of patients reporting 'moderate' levels or above. This was followed by 'feeling that not in as good physical health as most of your friends' (59%), 'not feeling well most of the time in the past few years' (54%), and 'feeling weak in parts of body' (45%). 'Headache' was the most common pain-related symptom with 43% reporting 'moderate' or above. Pearson's product-moment correlations revealed that somatic symptoms generally increased as a function of overall depressive (r=0.43), with 'feeling fatigued, weak, or tired all over' (r=0.50), 'feeling that not in as good physical health as most of your friends' (r=0.42), 'feeling weak in parts of body' (r=0.41), 'heavy feeling in arms and legs' (r=0.34), 'not feeling well most of the time in the past few years' (r=0.32), and 'headache' (r=0.31) showing the strongest correlation with overall HAMD scores. Non-parametric item response analyses showed that many somatic symptoms demonstrate good relationship between item response and the overall severity of depression. In particular, 'feeling fatigued, weak, or tired all over' exhibited good discriminative properties across the full range of severity for depression. LIMITATIONS: The analysis utilized data from a 'restricted' patient population in drug trials sponsored by a pharmaceutical company. CONCLUSIONS: These results demonstrate a high prevalence and association of somatic symptoms in patients with MDD, including feelings of fatigue, physical malaise and pain-related symptoms, which could be potentially useful in the assessment of depression and in the evaluation of treatment strategies.

Symptoms of anxiety in depression: assessment of item performance of the Hamilton Anxiety Rating Scale in patients with depression.

BACKGROUND: Although diagnostically dissociable, anxiety is strongly co-morbid with depression. To examine further the clinical symptoms of anxiety in major depressive disorder (MDD), a non-parametric item response analysis on "blinded" data from four pharmaceutical company clinical trials was performed on the Hamilton Anxiety Rating Scale (HAMA) across levels of depressive severity. METHODS: The severity of depressive symptoms was assessed using the 17-item Hamilton Depression Rating Scale (HAMD). HAMA and HAMD measures were supplied for each patient on each of two post-screen visits (n=1,668 observations). Option characteristic curves were generated for all 14 HAMA items to determine the probability of scoring a particular option on the HAMA in relation to the total HAMD score. Additional analyses were conducted using Pearson's product-moment correlations. RESULTS: Results showed that anxiety-related symptomatology generally increased as a function of overall depressive severity, though there were clear differences between individual anxiety symptoms in their relationship with depressive severity. In particular, anxious mood, tension, insomnia, difficulties in concentration and memory, and depressed mood were found to discriminate over the full range of HAMD scores, increasing continuously with increases in depressive severity. By contrast, many somatic-related symptoms, including muscular, sensory, cardiovascular, respiratory, gastro-intestinal, and genito-urinary were manifested primarily at higher levels of depression and did not discriminate well at lower HAMD scores. CONCLUSIONS: These results demonstrate anxiety as a core feature of depression, and the relationship between anxiety-related symptoms and depression should be considered in the assessment of depression and evaluation of treatment strategies and outcome.

Reliability and validity of the Sexual Interest and Desire Inventory-Female (SIDI-F), a scale designed to measure severity of female hypoactive sexual desire disorder.

The Sexual Interest and Desire Inventory-Female (SIDI-F) is a 13-item scale developed as a clinician-administered assessment tool to quantify the severity of symptoms in women diagnosed with hypoactive sexual desire disorder (HSDD). The present investigation assessed the reliability and validity of the SIDI-F as a measure of HSDD severity. Results show that the SIDI-F exhibits excellent internal consistency, with Cronbach's alpha of 0.9. The validity of the SIDI-F as a measure of HSDD severity was confirmed by a number of observations. Women with a clinical diagnosis (Diagnostic and Statistical Manual of Mental Disorders [DSM-IV-TR; American Psychiatric Association, 2000]) of HSDD had significantly lower SIDI-F scores than women not meeting diagnostic criteria for any subtype of female sexual dysfunction and women diagnosed with female orgasmic disorder. There was a high correlation between scores on the SIDI-F and scores on the Female Sexual Function Index (FSFI; Rosen et al., 2000) and an interactive voice response version of the Changes in Sexual Functioning Questionnaire (CSFQ; Clayton, McGarvey, & Clavet, 1997; Clayton, McGarvey, Clavet, & Piazza, 1997), two validated measures that assess general female sexual dysfunction. In contrast, there was a poor correlation between SIDI-F scores and scores on a slightly modified Marital Adjustment Scale (Locke, Wallace, 1959; MAS), an assessment of general (nonsexual) relationship satisfaction. Taken together, the results of the present investigation indicate that the SIDI-F is a reliable and valid measure of HSDD severity, independent of relationship issues.