A double-blind, randomized controlled clinical trial comparing eicosapentaenoic acid versus docosahexaenoic acid for depression.

OBJECTIVE: To compare 2 omega-3 (n-3) preparations enriched with eicosapentaenoic acid (EPA) versus docosahexaenoic acid (DHA) as monotherapy for major depressive disorder (MDD) in a 2-site, placebo-controlled, randomized, double-blind clinical trial. METHOD: 196 adults (53% female; mean [SD] age = 44.7 [13.4] years) with DSM-IV MDD and a baseline 17-item Hamilton Depression Rating Scale (HDRS-17) score ≥ 15 were randomized equally from May 18, 2006, to June 30, 2011, to 8 weeks of double-blind treatment with oral EPA-enriched n-3 1000 mg/d, DHA-enriched n-3 1,000 mg/d, or placebo. RESULTS: 154 subjects completed the study. Modified intent-to-treat (mITT) analysis (n = 177 subjects with ≥ 1 postbaseline visit; 59.3% female, mean [SD] age 45.8 [12.5] years) employed mixed-model repeated measures (MMRM). All 3 groups demonstrated statistically significant improvement in the HDRS-17 (primary outcome measure), 16-item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16), and Clinical Global Improvement-Severity Scale (CGI-S) (P < .05), but neither n-3 preparation separated from placebo (P > .05). Response and remission rates were in the range of 40%-50% and 30%, respectively, for all treatments, with no significant differences between groups. One subject receiving EPA-enriched n-3 discontinued due to worsening depression, and 1 subject receiving placebo discontinued due to an unspecified "negative reaction" to pills. CONCLUSIONS: Neither EPA-enriched nor DHA-enriched n-3 was superior to placebo for the treatment of MDD. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00517036.

Translating the evidence on atypical depression into clinical practice.

Although the introduction of selective serotonin reuptake inhibitors ushered in an era of relative comfort among clinicians in treating major depressive disorder (MDD), no one antidepressant is appropriate for all patients with depression. In patients with atypical symptoms, efficacy of therapeutic agents may be greatest for monoamine oxidase inhibitors (MAOIs). The first-generation MAOIs such as phenelzine and isocarboxazid were largely nonselective inhibitors of both subtypes of MAO, MAO(A) and MAO(B). These medications carried with them dietary restrictions, medication restrictions, a need for titration, and a substantial side effect burden, including weight gain, cardiovascular effects (i.e., hypertension and hypotension), and sexual side effects. The second-generation MAOI selegiline is selective for MAO(B) at oral doses of up to 10 mg/day. At higher doses, selegiline loses selectivity and inhibits both MAO(A) and MAO(B). Because the antidepressant effects of selegiline occur with the higher doses that impact tyramine pressor effects, an ideal formulation would optimize dose while minimizing adverse effects of MAO(A) inhibition in the gastrointestinal mucosa. Efforts in this direction led to formulation of the selegiline transdermal system (STS). The most common side effects are irritation at the patch site and insomnia. Drugs to be avoided with the STS include some pain medications, antidepressants, muscle relaxants, and any form of sympathomimetic amines, which include amphetamines, cold products with pseudoephedrine, phenylephrine, phenylpropanolamine, ephedrine, and stimulant-containing weight-reduction agents. Although no tyramine-restricted diet is required for the 6-mg/24-hour patch, a restricted diet is recommended for the higher-dose patches to reduce the risk of hypertensive crisis.

Use of the quality of well-being self-administered version (QWB-SA) in assessing health-related quality of life in depressed patients.

BACKGROUND: This study evaluated the cross-sectional and longitudinal relationship between depression severity and the Quality of Well-Being scale self-administered version (QWB-SA) in subjects diagnosed with current major depression. METHODS: The research design was prospective and observational. Data were collected on a convenience sample of 58 subjects. Additional measures included the Quality of Well-Being scale interviewer-version (interviewer-QWB), Hamilton Rating Scale for Depression (HRSD-17), Beck Depression Inventory, and each were collected at baseline, 4 weeks, and 4 months postmedication treatment. RESULTS: Cross-sectional and longitudinal QWB-SA scores were significantly correlated with depression severity and the interviewer-QWB. Treatment response, defined as 50% improvement in HRSD-17, was associated with 0.10 and 0.16 unit changes in the QWB-SA at 4 weeks and 4 months, respectively. The QWB-SA was significantly and negatively correlated with cross-sectional and longitudinal depression severity. LIMITATIONS: The study design was observational and used a convenience sample of subjects. CONCLUSIONS: The QWB-SA is less expensive to administer than the interviewer-QWB and is a useful alternative for determining the effectiveness and cost-effectiveness of treatments for depression relative to other physical and mental illness treatments.