Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- MADRS Rating Scale Change
研究概览
简要总结
Bipolar depression is one of the least studied depressive illnesses. The standard practice for many doctors is to use antidepressant medicines, but there are few studies on the long-term results of these medicines. The goal of this study is to look at how effective and safe these medicines are in treating bipolar depression when taken with a mood stabilizer medicine.
The drug being studied is citalopram, also known as Celexa. Celexa is FDA approved for the treatment of major depression, but is not FDA approved for the treatment of bipolar depression. It is, however, standard practice for many doctors is to use antidepressants, like Celexa, to treat their patients with bipolar disorder depression.
The drug will be studied in three ways. We will see if it helps treat depressive symptoms. We will see how the drug affects the brain using PET and fMRI scans. Finally, we will look at the possibility that there may be a gene that could predict if a person would get better taking the drug using genetics.
详细描述
The problem of interest
Depression is a common serious illness, with great personal suffering and a 10% or more risk of suicide. There are two kinds of depression, bipolar (depression alternating with mood swings) and unipolar ("simple" depression, or major depressive disorder). In both kinds of depression, antidepressants are commonly used. However, unlike unipolar depression, where a good deal of research supports this use, there is very little research on antidepressant use in bipolar disorder. Some studies support benefit with antidepressants for bipolar depression; i.e., if one is depressed, antidepressants can help a patient get better in the short-term. However, long-term studies are limited; the few available studies with older antidepressants did not demonstrate long-term preventive benefit. Some clinicians think new generation antidepressants (like Prozac and other serotonin reuptake inhibitors) are safer and more effective than the older antidepressants. Yet there are no rigorous long-term studies of new generation antidepressants in bipolar disorder. Recent observational studies with new antidepressants suggest that they may be harmful to some patients with bipolar disorder.
Clinicians are thus left in a quandary. Antidepressants appear to be effective in the short term, but should the antidepressants (especially new generation antidepressants) be continued long-term? Some studies support both approaches. Importantly, some evidence exists that antidepressants can make many patients worse, with more and more depression or mania over time.
This is a major public health problem, since clinicians prescribe antidepressants for the long-term in up to 80% of patients with bipolar disorder. This represents standard treatment, despite the limitations of the available evidence and the suggestion that in some patients such antidepressant use may be harmful.
This study is also looking at possible biological predictors that may reflect an individual patients' likelihood that he or she will respond to a specific treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current age ≥18 years
- •DSM-IV diagnosis of BPD, type-I, or type-II
- •Current major depressive episode using DSM-IV criteria, lasting 8 weeks or longer.
- •Use of lithium, divalproex, carbamazepine, or lamotrigine at therapeutic serum levels or doses for ≥4 weeks prior to study entry, or willingness to accept one of these agents.
- •Prior to initial evaluations, each subject must provide competent, written, informed consent.
排除标准
- •Past non-response to a therapeutic trial of R,S-citalopram (≥100 mg/day for ≥8 weeks).
- •Previous intolerance of R,S-citalopram;
- •Diagnosis of unipolar depression
- •Diagnosis of schizoaffective disorder
- •Serious medical illness with acute instability (cardiac, respiratory, hepatic, renal), based on hospitalization in the past month
- •Abnormal thyroid function tests
- •Previous allergic reaction to or inability to tolerate lithium, divalproex, or carbamazepine at therapeutic serum levels.
- •Current or past renal dysfunction if taking lithium
- •Current or past hepatitis or other liver disease if taking divalproex
- •Current or past hematologic disease if on carbamazepine
- •Severe suicidal ideation, plan or intent, as documented by a score of ≥4 on the Montgomery Åsberg Depression Rating Scale suicidality item (Item 10).
- •Presence of psychosis
- •Cognitive impairment sufficient to impair ability to give informed consent.
- •Current pregnancy, or inability to utilize contraception
- •The presence of any metallic implants
- •History of claustrophobia
研究组 & 干预措施
citalopram + mood stabilizer
All patients are on baseline mood stabilizers and are randomized to receive citalopram or placebo. In this arm, they are randomly assigned to citalopram.
干预措施: citalopram + mood stabilizer (Drug)
placebo + mood stabilizer
All patients are on baseline mood stabilizers and are randomized to receive citalopram or placebo. In this arm, they are randomly assigned to placebo
干预措施: placebo + mood stabilizer (Drug)
结局指标
主要结局
MADRS Rating Scale Change
时间窗: 6 weeks
Montgomery Asberg Depression Rating scale assessed in mixed effects regression model. The total range for the scale is 0 to 60. Lower values involve less depression, while higher values involve worse depression. The change in the MADRS scale is interpreted as higher values meaning better outcomes, because more depressive symptoms are improved.
次要结局
未报告次要终点