Objective: US Food and Drug Administration (FDA) warnings recommend monitoring negative symptoms associated with the initiation of antidepressant medications as these symptoms may interfere with full recovery and pose safety concerns. There is currently no brief, reliable rating instrument for assessing treatment-emergent, negative symptoms. We evaluated the psychometric properties of 2 versions of the newly developed 17-item Concise Associated Symptom Tracking (CAST) scale, the CAST Clinician Rating (CAST-C) and CAST Self-Rated (CAST-SR), which are brief instruments designed to measure the 5 relevant associated symptom domains (irritability, anxiety, mania, insomnia, and panic).
Method: The study enrolled 265 outpatients with major depressive disorder (MDD), from July 2007 through February 2008, into an 8-week, open-label trial with a selective serotonin reuptake inhibitor. Diagnosis of MDD was determined by the Psychiatric Diagnostic Screening questionnaire and an MDD checklist based on DSM-IV-TR criteria. Suicidality (suicidal ideation with associated behaviors) is 1 of 9 symptoms of MDD (depressed mood, loss of interest, appetite or weight change, sleep disturbance, reduced concentration or indecisiveness, fatigue or decreased energy, psychomotor agitation or retardation, feelings of worthlessness or excessive guilt). Psychometric evaluations were conducted on both versions of the CAST.
Results: Cronbach α was .80 (CAST-C) and .81 (CAST-SR). Factor analysis identified 5 factors for each scale: (1) irritability, (2) anxiety, (3) mania, (4) insomnia, and (5) panic. When the item that cross-loaded on 2 factors was eliminated, the 16-item solution had a better goodness of fit (CAST-C: 0.90 vs 0.87; CAST-SR: 0.88 vs 0.84). Cronbach α for the 16-item versions was .77 (CAST-C) and .78 (CAST-SR). The 5 associated CAST symptom domains correlated well with other standard measures of these domains.
Conclusions: The 16-item CAST-C and CAST-SR demonstrated excellent psychometric properties. These are potentially useful measures for monitoring treatment-emergent negative symptoms associated with antidepressants, as recommended by the FDA.
Trial registration: Clinicaltrials.gov Identifier: NCT00532103.
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