Determining Optimal Continuation Treatment Duration for Depressed Children and Adolescents
Childhood Depression: Remission and Relapse
調査の概要
詳細な説明
Depression is a serious medical illness that affects all ages and populations. However, it has only been within the last 10 years that sufficient attention has been devoted to researching treatments for depression in children and adolescents. Symptoms of depression in this age group vary, but some common signs include pretending to be sick, refusing to go to school, clinging to a parent, or worrying that a parent may die. Older children may sulk, get into trouble at school, act in a negative or grouchy way, or feel misunderstood. Recent studies on selective serotonin reuptake inhibitors (SSRIs), one class of antidepressant medications, have shown that SSRIs are effective in reducing depression symptoms. The optimal duration of treatment, however, has yet to be established. This study will determine the optimal length of continuation treatment with fluoxetine for children and adolescents with major depressive disorder, as well as the factors that may contribute to positive response during acute and continuation treatment.
Participants in this study will first attend three study visits over a 2-week period to determine eligibility. All eligible individuals will be treated with fluoxetine for 12 weeks. Dosages will be determined by the study physician and will be based on clinical response to treatment. Study visits will occur weekly for the first 4 weeks and biweekly for the remaining 2 months. Depression symptoms, general changes, and adverse reactions will be assessed. Participants whose symptoms have improved will be eligible to enter the discontinuation phase of the study, which will entail random assignment to either fluoxetine or placebo for an additional 24 weeks. Study visits will occur biweekly for 3 months and monthly for the remaining 3 months. Depression symptoms and medication side effects will be assessed at these visits.
研究の種類
入学
段階
- 適用できない
連絡先と場所
研究場所
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Texas
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Dallas、Texas、アメリカ、75235
- Children's Medical Center at Dallas, Outpatient Psychiatry Clinic
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Currently being treated on an outpatient basis
- Currently attending school
- Diagnosis of non-psychotic major depressive disorder (MDD)
- Duration of illness is at least 4 weeks
- In good general medical health
- Normal intelligence
Exclusion Criteria:
- Lifetime history of any psychotic disorder, including psychotic depression
- Diagnosis of bipolar I or II disorder
- History of alcohol or substance abuse or dependence within 6 months of study entry
- Lifetime history of anorexia nervosa or bulimia
- Pregnant or breastfeeding
- Does not agree to use an effective form of contraception (i.e., IUD, birth control pills, or barrier devices)
- Any chronic medical illness requiring regular medication
- Currently taking medication with psychotropic effects (i.e., anticonvulsants, steroids, etc.), other than stable stimulant treatment
- A first degree relative has bipolar I disorder
- Previous adequate treatment with fluoxetine was ineffective (defined as at least 20 mg/day for 4 weeks)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
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再発する時間
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Measured throughout the study: Relapse
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二次結果の測定
結果測定 |
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Measured at Weeks 12 and 36: Functioning
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Baseline characteristics
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協力者と研究者
捜査官
- 主任研究者:Graham J. Emslie, MD、UT Southwestern Medical Center at Dallas
出版物と役立つリンク
一般刊行物
- Nakonezny PA, Hughes CW, Mayes TL, Sternweis-Yang KH, Kennard BD, Byerly MJ, Emslie GJ. A comparison of various methods of measuring antidepressant medication adherence among children and adolescents with major depressive disorder in a 12-week open trial of fluoxetine. J Child Adolesc Psychopharmacol. 2010 Oct;20(5):431-9. doi: 10.1089/cap.2009.0108.
- Kennard BD, Mayes TL, Chahal Z, Nakonezny PA, Moorehead A, Emslie GJ. Predictors and Moderators of Relapse in Children and Adolescents With Major Depressive Disorder. J Clin Psychiatry. 2018 Mar/Apr;79(2):15m10330. doi: 10.4088/JCP.15m10330.
- Tao R, Emslie G, Mayes T, Nakonezny P, Kennard B, Hughes C. Early prediction of acute antidepressant treatment response and remission in pediatric major depressive disorder. J Am Acad Child Adolesc Psychiatry. 2009 Jan;48(1):71-8. doi: 10.1097/CHI.0b013e318190043e.
- Kennard BD, Hughes JL, Stewart SM, Mayes T, Nightingale-Teresi J, Tao R, Carmody T, Emslie GJ. Maternal depressive symptoms in pediatric major depressive disorder: relationship to acute treatment outcome. J Am Acad Child Adolesc Psychiatry. 2008 Jun;47(6):694-699. doi: 10.1097/CHI.0b013e31816bfff5.
研究記録日
主要日程の研究
研究開始
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- R01MH039188 (米国 NIH グラント/契約)
- DSIR CT-M
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