STAR*D （ Sequenced Treatment Alternatives to RelieveDepression；うつ病軽減のための代替的連続治療法）2007
昔の日本のお医者さんの経験を大切にしよう、いった趣旨のことを書いたけれど、
本当に偉大ならば、実証的に証明できるはずだ。そして現在ではその手順もだいたい決まっている。
最近の話題はSTAR*D （ Sequenced Treatment Alternatives to Relieve Depression；うつ病軽減のための代替的連続治療法）臨床試験である。
これは、DSMで操作的に診断決定した患者さんに対して、あらかじめ決定された治療プロトコールつまり治療手順に従った治療をして、結果を報告し、大規模な統計処理をするものだ。まさにEBMである。
治療効果については、時期ごとに、
the 17-item Hamilton Depression Rating Scale (HAM-D) と
the 16-item Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) を用いて評価する。
ところが、その治療プロトコールの最初にあるのがcitalopramであり、これはSSRIの一つで、製品名Celexa、日本では認可されていない。(アメリカでよく使われる抗うつ薬の表はこちら。)
Sequenced Treatment Alternatives とあるように、平たく言えば、citalopramでだめな人はどんな人で、
どんなタイプにはどんな代替療法がいいかという話になっていて、
そこでやっとゾロフトや認知療法が登場する。
つまり、
レベル1（citalopramの単独療法）、
レベル2（bupropion、sertralineまたはvenlafaxineの単独療法、あるいはcitalopramをbupropionまたはbuspironeで増強）、
レベル3（mirtazapineまたはnortriptyline、または、レベル2の薬物にリチウムまたはトリヨードチロニン（T3）を追加。）
レベル4では、事前の3レベルで寛解を達成しなかった患者に、モノアミン酸化酵素（monoamine oxidase：MAO）阻害薬tranylcypromine、または持続放出性venlafaxine＋mirtazapineの併用。
などという具合に、治療が進む。
日本で認可されているのは、
sertraline = ジェイゾロフト
nortriptyline = ノリトレン
リチウム = リーマス
トリヨードチロニン（T3）
citalopramを第一選択薬にできない日本の私たちはどうすればいいのだろう。
いきなりAlternativesなのか？
(実際の治療には、パキシル、ジェイゾロフト、ルボックス、デプロメール、トレドミンを使い分ければ充分ですが、このような大規模な研究に参加できないではないかということを言いたいわけです。)
Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice.
Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA,
Warden D, Ritz L, Norquist G, Howland RH, Lebowitz B, McGrath PJ, Shores-Wilson K, Biggs MM, Balasubramani GK, Fava M; STAR*D Study Team.
Department of Psychiatry, University of Texas Southwestern Medical Center, Exchange Park Express, American General Tower, 6363 Forest Park Rd., Suite 1300, Dallas, TX 75390-9119, USA. madhukar.trivedi@utsouthwestern.edu
OBJECTIVE: Selective serotonin reuptake inhibitors (SSRIs) are widely used to treat depression, but the rates, timing, and baseline predictors of remission in “real world” patients are not established. The authors’ primary objectives in this study were to evaluate the effectiveness of citalopram, an SSRI, using measurement-based care in actual practice, and to identify predictors of symptom remission in outpatients with major depressive disorder. METHOD: This clinical study included outpatients with major depressive disorder who were treated in 23 psychiatric and 18 primary care “real world” settings. The patients received flexible doses of citalopram prescribed by clinicians for up to 14 weeks. The clinicians were assisted by a clinical research coordinator in the application of measurement-based care, which included the routine measurement of symptoms and side effects at each treatment visit and the use of a treatment manual that described when and how to modify medication doses based on these measures. Remission was defined as an exit score of <or=7 on the 17-item Hamilton Depression Rating Scale (HAM-D) (primary outcome) or a score of <or=5 on the 16-item Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) (secondary outcome). Response was defined as a reduction of >or=50% in baseline QIDS-SR score. RESULTS: Nearly 80% of the 2,876 outpatients in the analyzed sample had chronic or recurrent major depression; most also had a number of comorbid general medical and psychiatric conditions. The mean exit citalopram dose was 41.8 mg/day. Remission rates were 28% (HAM-D) and 33% (QIDS-SR). The response rate was 47% (QIDS-SR). Patients in primary and psychiatric care settings did not differ in remission or response rates. A substantial portion of participants who achieved either response or remission at study exit did so at or after 8 weeks of treatment. Participants who were Caucasian, female, employed, or had higher levels of education or income had higher HAM-D remission rates; longer index episodes, more concurrent psychiatric disorders (especially anxiety disorders or drug abuse), more general medical disorders, and lower baseline function and quality of life were associated with lower HAM-D remission rates. CONCLUSIONS: The response and remission rates in this highly generalizable sample with substantial axis I and axis III comorbidity closely resemble those seen in 8-week efficacy trials. The systematic use of easily implemented measurement-based care procedures may have assisted in achieving these results.
PMID: 16390886 [PubMed – indexed for MEDLINE]
