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June 8, 2007 — In patients with major depressive disorder, liothyronine added to sertraline may be helpful in those most likely to benefit from combined therapy, according to the results of a randomized controlled trial published in the June issue of the Archives of General Psychiatry.
"Subject to regulations regarding off-label treatment, many clinicians already use liothyronine augmentation for treatment-resistant depressed patients, [and] our study suggests that liothyronine enhances response in patients who are not definitively resistant," Dr. Lerer said. "This is a relatively novel clinical concept — use of liothyronine as an enhancer to strengthen therapeutic outcome and not only as an augmenter in resistant patients. How to strengthen response and bring the maximum number of patients to remission is an important current concern in clinical psychopharmacology."
In this double-blind trial at outpatient referral centers, 124 adult outpatients meeting unmodified Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for major depressive disorder without psychotic features were randomized to receive sertraline hydrochloride (50 mg/day for 1 week, 100 mg/day thereafter) plus liothyronine sodium (20 or 25 µg/day for 1 week, 40 or 50 µg/day thereafter) or sertraline plus placebo for 8 weeks.
The main end point was categorical response to treatment, defined as a 50% or greater decrease in scores on the 21-item Hamilton Rating Scale for Depression (HRSD) from baseline to study end point. Secondary outcomes were remission rate, defined as a final HRSD score of 6 or less, and visual analog scale improvement (50% of greater improvement) or remission (75% improvement).
In the intent-to-treat population, HRSD response rates were 70% in the sertraline-liothyronine group and 50% in the sertraline-placebo group (P = .02; odds ratio [OR], 2.93; 95% confidence interval [CI], 1.23 - 7.35). Remission rates were 58% with sertraline-liothyronine and 38% with sertraline-placebo (P = .02; OR, 2.69; 95% CI, 1.16 - 6.49).
"The main take-home point is that concurrent treatment with T3 in addition to an SSRI antidepressant is associated with higher response and remission rates compared to treatment with the antidepressant alone," Michael Gitlin, MD, a professor of psychiatry at Geffen School of Medicine of University of California, Los Angeles, told Medscape. Dr. Gitlin was not involved with the study but was asked to provide independent commentary. "If this finding is replicated, we might consider starting patients on an antidepressant plus T3 in some cases."
Compared with patients treated with sertraline-liothyronine who did not have remissions, those who did have remissions had lower baseline T3 values (t48 = 3.36; P < .002). In the sertraline-liothyronine group, remission was associated with decreased serum thyrotropin values (F1,73 = 4.00; P < .05).
"Besides the clinically relevant findings, we observed an important association between the endocrine effects of liothyronine and its therapeutic effects, which could help to understand mechanism of action," Dr. Lerer said. "The relatively low sertraline dose should be taken into consideration when considering clinical implications."
In the current study, liothyronine supplementation did not affect the frequency of adverse events, including those that might be expected to be more frequent with liothyronine, such as palpitations, sweating, and nervousness. However, Dr. Lerer warned that "the duration of treatment with liothyronine needs to be circumscribed because potential adverse effects of long-term effects are not known. Monitoring of thyroid function is important even with short-term treatment."
Arch Gen Psychiatry. 2007;64:679-688.
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