OBJECTIVES: Clinical outcome assessments (COAs) are clinician-reported outcomes (ClinROs), patient-reported outcomes (PROs), observer-reported outcomes (ObsROs), and performance outcomes (PerfROs) tools used to assess the patient’s symptom, impact, and overall mental state. PRO measures, specifically developed to capture the patients’ perspective without clinician interpretation, are considered an approved means to support labeling by the Food and Drug Administration (FDA). This study aims to identify the extent to which COAs were used to support label claims and to identify the prevalence of PRO specific measures in mental health drugs approved by the FDA in the period 2006-2014. METHODS: New drugs used to treat mental health conditions approved by the FDA from 2006-2014 were identified and labels were retrieved from using the Drugs@FDA database. The “Indications and Usage” and “Clinical Studies” sections of each label were reviewed and relevant indications and concordant COA data was extracted and categorized by type using PROQOLID. RESULTS: A total of 20 FDA-approved drugs for use in mental health conditions were identified. Of these, 18 labels included clinical study data and 14 labels used the results of COAs to support 19 indications; major depressive disorder  (n=5), schizophrenia and/or schizoaffective disorder (n=5), attention deficit hyperactivity disorder (n=3), bipolar mania (n=2), insomnia (n=2), seasonal affective disorder (n=1), depressive episodes associated with bipolar I disorder (n=1). Clinical studies included 32 COAs used 47 different times to support drug/indication labeling; 39 ClinROs, 4 ObsROs, and 4 PerfROs (none employed PRO measures). COAs were used to measure primary efficacy endpoints (n=41), to establish safety (n=2) and to determine study eligibility (n=7) (not mutually exclusive). Thirteen out of 14 labels demonstrated efficacy by using a COAs. CONCLUSIONS: All mental health drug labels approved by the FDA since 2006 utilized clinical outcome assessments to support drug efficacy and labeling, however PROs were underutilized.