A Comparison of Two Different Treatments for Major Depression With Psychotic Features: Ziprasidone vs. Combined Sertraline and Haloperidol
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- 21 Item Hamilton Depression Rating Scale
研究概览
简要总结
The purpose of this study is to compare ziprasidone (Geodon) monotherapy for the treatment of psychotic major depression (PMD)with an antidepressant/antipsychotic combined therapy.
详细描述
Psychotic depression is a well-established DSM-IV diagnostic subtype indicating the presence of hallucinations and/or delusions as part of the clinical presentation. Currently the treatment of choice for psychotic depression is either electroconvulsive therapy or combination of antipsychotic and antidepressant medications. Ziprasidone will be compared to standard of care treatment comprising a combination of an antidepressant, sertraline and an antipsychotic, haloperidol, over a 12-week period. An additional 12-week extension phase is also included for responders to the initial study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, aged 18-70 years
- •If female, must state willingness to use medically accepted methods of birth control (if of reproductive age) and have negative pregnancy test
- •Ability to understand study procedures and provide written informed consent
- •A DSM-IV diagnosis of Major Depressive Disorder, with psychotic features, based on the Structured Clinical Interview for DSM-IV (SCID)
- •Hamilton Depression Rating Scale score (21-item HDRS) greater than or equal to 22
排除标准
- •A current or lifetime DSM-IV diagnosis of Bipolar Disorder, Schizophrenia or Schizoaffective Disorder
- •A DSM-IV diagnosis of alcohol or substance abuse or dependence within 3 months of study entry
- •A QTc greater than 460 msec or an abnormal EKG (except minor abnormalities considered by the site investigator to be clinically insignificant)
- •A heart rate less than or equal to 50
- •A personal or family history of QTc
- •Any current or past history of syncope
- •Concurrent treatment with medications associated with prolongation of the QTc
- •Concurrent treatment with medications that may affect magnesium or potassium, such as diuretics
- •Any acute, unstable or serious medical illness (eg, AIDS, history of seizures, history of CVAs).
- •Baseline blood chemistries that are outside local reference ranges and which are felt clinically significant by the site investigator, or a potassium, magnesium or calcium level outside of local reference ranges or liver function tests that are greater than 20% above the upper limit of local reference ranges. If magnesium and/or potassium are below the lower limit of the local laboratory norm, they may be repeated and rechecked during the screening phase, and if within laboratory norms, the subjects may be included.
- •History of unstable cardiovascular disease
- •A significant risk of suicide in the judgement of the site investigator
- •A history of allergy or hypersensitivity to haloperidol, sertraline or ziprasidone
- •Any history of neuroleptic malignant syndrome
- •Treatment with sertraline or ziprasidone within 30 days of study entry
- •History of recent treatment with any long acting psychotropic medications
- •Treatment with a MAO-inhibitor within 14 days of study entry
- •Treatment with an investigational drug within 30 days of study entry
- •Current use of carbamazepine, nefazodone, ketoconazole or erythromycin
- •A positive pregnancy test
- •A positive drug screen unless attributable to a prescribed medication (e.g. benzodiazepines)
研究组 & 干预措施
Ziprasidone
Subjects in this arm received ziprasidone with a placebo to maintain the blind
干预措施: Ziprasidone (Drug)
Sertraline/Haloperidol
Subjects in this arm received a combination of sertraline and haloperidol with a placebo to maintain the blind. Sertraline dosage was 150-200mg/day and haloperidol was 6-8mg/day based on tolerance.
干预措施: Sertraline (Drug)
Sertraline/Haloperidol
Subjects in this arm received a combination of sertraline and haloperidol with a placebo to maintain the blind. Sertraline dosage was 150-200mg/day and haloperidol was 6-8mg/day based on tolerance.
干预措施: Haloperidol (Drug)
结局指标
主要结局
21 Item Hamilton Depression Rating Scale
时间窗: 12 week
The scale rates 21 symptoms related to major depression. A total score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Total scores range from a minimum of 0(not ill) to a maximum of 64 (severely ill).
Clinical Global Impression Improvement Scale
时间窗: 12 weeks
A 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Overall the scale goes from a minimum of 1(very much improved) to a maximum of 7(very much worse).
Brief Psychiatric Rating Scale at 12 Weeks
时间窗: 12 weeks
A rating scale used to measure psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour. Each symptom is rated 1-7 and in this version a total of 24 symptoms are scored. Thus the total range of scores is from a minimum of 24 to a maximum of 168. Lower scores are considered better, so the minimum total score of 24 indicates someone with no psychiatric symptoms, while any score over 40 is considered at least moderately severe, with only the most severely ill patients scoring over 60.
次要结局
未报告次要终点