Association between lithium serum level, mood state, and patient-reported adverse drug reactions during long-term lithium treatment: a naturalistic follow-up study.

OBJECTIVES: To assess the association between mood state and the prevalence and the severity of lithium adverse drug reactions (ADRs). METHODS: A 26-year follow-up study was conducted among patients > or =18 years treated at the outpatient lithium clinic of the University Medical Center Groningen, The Netherlands, between November 1973 and December 2000. At each monthly scheduled visit, patients were questioned by a research nurse in a standardized manner about the presence and the severity of nine specific ADRs that frequently occur as a consequence of lithium treatment and that can be identified by the patients themselves. In addition, lithium serum level was measured and mood state was rated at each visit. RESULTS: A total of 186 patients participated and the median duration of follow-up was 5.7 years (interquartile range 2.2-11.8 years). We observed an increased prevalence and severity of ADRs with increased lithium serum level (p < 0.05), also when adjusting for mood state. The prevalence and the severity of ADRs increased with decreasing mood state into the depressive range and decreased with mood state increasing into the manic range (p < 0.05), also when adjusting for lithium serum level. Taking into account the intraindividual dependency of the data resulted in a statistically significant (p < 0.001) association between, respectively, lithium serum level, mood state, and the prevalence and severity of ADRs. CONCLUSIONS: Both physicians and researchers need to be aware that lithium serum level and mood state are independently associated with patient reporting and severity scoring of ADRs, which may complicate objective assessment of ADRs.

The reliability and validity of the Seasonal Pattern Assessment Questionnaire: a comparison between patient groups.

BACKGROUND: The Seasonal Pattern Assessment Questionnaire (SPAQ) is a frequently used screening instrument in the research on Seasonal Affective Disorder (SAD). Nevertheless, studies on its reliability and validity are relatively scarce. In the present study the reliability and the contrast validity of the SPAQ are investigated. METHODS: SAD patients, selected by means of a clinical interview, non-seasonal depressed out-patients, non-depressed out-patients, and a control group, are contrasted to estimate the discriminating power of the SPAQ. Also, the reliability and factor structure of the seasonality and the climate subscales are investigated. To study food intake the Seasonal Food Preference Questionnaire (SFPQ) was developed. RESULTS: The SAD criterion of the SPAQ shows good specificity (94%), but a low sensitivity (44%). Discriminant analysis shows sufficient ability to classify subjects (81% correctly classified). The Global Seasonality Scale has a good internal consistency. It consists of two factors, a psychological factor and a food factor. The SFPQ is sensitive for carbohydrate intake by SAD patients. LIMITATIONS: Most SAD patients had received treatment and completed the SPAQ while they were not depressed, which may have influenced the sensitivity. CONCLUSIONS: The SPAQ is not sensitive enough to be considered a diagnostic instrument for SAD. Nevertheless, it is accurate enough to be used as a screenings instrument. The only false positives were found in the depressive group. The accuracy of prevalence Figs. can be improved by completion of the SPAQ in the summer months, combined with the completion of a depression scale.

Lithium concentrations in plasma of lithium-treated psychiatric patients in the Netherlands: commentary on Cusin et al.

Seasonal variations in 68 psychiatric patients receiving prophylactic lithium treatment in the Netherlands between 1974 and 1994 were analyzed and compared with findings from Italy. Although lithium doses remained stable, there was a significant change in plasma levels of lithium, with values in spring and summer tending to exceed those in autumn and winter. These findings are similar to those reported in Italy, although the maximal seasonal change was approximately 5% in the Netherlands compared with approximately 10% in Italy. The difference could reflect the hotter summer climate in Italy, associated with increased perspiration. Future studies should measure perspiration levels directly.

Rate of improvement during and across three treatments for panic disorder with or without agoraphobia: cognitive behavioral therapy, selective serotonin reuptake inhibitor or both combined.

BACKGROUND: Existing literature on panic disorder (PD) yields no data regarding the differential rates of improvement during Cognitive Behavioral Therapy (CBT), Selective Serotonin Reuptake Inhibitor (SSRI) or both combined (CBT+SSRI). METHOD: Patients were randomized to CBT, SSRI or CBT+SSRI which each lasted one year including three months of medication taper. Participating patients kept record of the frequency of panic attacks throughout the full year of treatment. Rate of improvement on panic frequency and the relationship between rate of improvement and baseline agoraphobia (AG) were examined. RESULTS: A significant decline in frequency of panic attacks was observed for each treatment modality. SSRI and CBT+SSRI were associated with a significant faster rate of improvement as compared to CBT. Gains were maintained after tapering medication. For patients with moderate or severe AG, CBT+SSRI was associated with a more rapid improvement on panic frequency as compared to patients receiving either mono-treatment. LIMITATIONS: Frequency of panic attacks was not assessed beyond the full year of treatment. Second, only one process variable was used. CONCLUSIONS: Patients with PD respond well to each treatment as indicated by a significant decline in panic attacks. CBT is associated with a slower rate of improvement as compared to SSRI and CBT+SSRI. Discontinuation of SSRI treatment does not result in a revival of frequency of panic attacks. Our data suggest that for patients without or with only mild AG, SSRI-only will suffice. For patients with moderate or severe AG, the combined CBT+SSRI treatment is recommended.

A randomized trial of cognitive-behavioral therapy or selective serotonin reuptake inhibitor or both combined for panic disorder with or without agoraphobia: treatment results through 1-year follow-up.

OBJECTIVE: To establish the long-term effectiveness of 3 treatments for DSM-IV panic disorder with or without agoraphobia: cognitive-behavioral therapy (CBT), pharmacotherapy using a selective serotonin reuptake inhibitor (SSRI), or the combination of both (CBT + SSRI). As a secondary objective, the relationship between treatment outcome and 7 predictor variables was investigated. METHOD: Patients were enrolled between April 2001 and September 2003 and were randomly assigned to treatment. Academic and nonacademic clinical sites participated. Each treatment modality lasted 1 year. Pharmacotherapists were free to choose between 5 SSRIs currently marketed in The Netherlands. Outcome was assessed after 9 months of treatment (posttest 1), after discontinuation of treatment (posttest 2), and 6 and 12 months after treatment discontinuation (follow-up 1 and follow-up 2). RESULTS: In the sample (N = 150), 48% did not suffer from agoraphobia or suffered from only mild agoraphobia, while 52% suffered from moderate or severe agoraphobia. Patients in each treatment group improved significantly from pretest to posttest 1 on the primary outcome measures of level of anxiety (P < .001), degree of coping (P < .001), and remitter status (P < .001), as well as on the secondary outcome measures of depressive symptomatology (P < .001), and from pretest to posttest 2 for health-related quality of life (P < .001). Gains were preserved from posttest 2 throughout the follow-up period. Some superiority of CBT + SSRI and SSRI as compared with CBT was observed at posttest 1. However, at both follow-ups, differences between treatment modalities proved nonsignificant. Client satisfaction appeared to be high at treatment endpoint, while patients receiving CBT + SSRI appeared slightly (P < .05) more satisfied than those receiving CBT only. CONCLUSIONS: No fall-off in gains was observed for either treatment modality after treatment discontinuation. SSRIs were associated with adverse events. Gains produced by CBT were slower to emerge than those produced by CBT + SSRI and SSRI, but CBT ended sooner. TRIAL REGISTRATION: Netherlands Trial Register (www.trialregister.nl) Identifier: ISRCTN8156869.