The Interest of a Specific Combined Treatment (Psychotherapy and Pharmacotherapy) in Patients With Dissociative Disorders
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To study the efficacy of a specific combined treatment (psychotherapy and pharmacotherapy) on patients with dissociative disorders, in terms of patients with a favorable outcome by means of the DES scale.
研究概览
简要总结
The purpose of this observational study is to measure the efficacy of a specific combined treatment (psychotherapy and pharmacotherapy) on patients with dissociative disorders, in terms of patients with a favorable outcome by means of the Dissociative Experiences Scale (DES).
详细描述
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INTRODUCTION
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Background: Dissociative Disorders are frequent, but poorly understood and under-diagnosed [Foote et al., 2006; Spiegel, 2006], especially in psychiatric emergency units [Lazignac et al., 2005]. The management of this is commonly mixed up with psychotic, depressive and anxiety disorders.
The treatment of the dissociative disorders remains controversial. The psychotherapeutic guidelines proposed by International Society for the Study of Dissociative Disorders (ISSD) were recently adapted for the French speaking users [Damsa et al., 2005]. There is no consensus on which antipsychotic or antidepressant would be preferable for those patients who suffer from dissociative disorders, accompanied by depressive or psychotic symptoms. We have a very good clinical experience with quetiapine and escitalopram for this specific group of patients. 2. Rationale for this study; Clinical [Lazignac et al., 2005] and neurobiological [Kelley-Puskas et al., 2005] reviews on dissociative disorders emphasize the value of a first open label study on the effects of specific combined psychotherapy and pharmacotherapy in patients with dissociative disorders [Damsa et al., 2006]. 2. STUDY OBJECTIVES
- Primary objective
- The efficacy of specific combined psychotherapy and pharmacotherapy in patients with dissociative disorders, in terms of favorable outcome (DES scale).
- Secondary objectives
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent
- •DES-score greater than 30 and positive (DSM-IV) criteria for dissociative disorder using SCID for DSM IV
- •Age 18 - 65 years
- •Female patients of childbearing potential must have a negative urinary pregnancy test
- •Able to understand and comply with the requirements of the study
- •Good physical health as determined by medical history and physical examination.
排除标准
- •Pregnancy/lactation
- •Suicidal behaviour requiring hospitalisation or borderline personality disorder
- •Substance dependence
- •Treatment with psychotropic or cholesterol-lowering medication
- •Known intolerance or lack of response to the medication that will be prescribed in the study.
- •Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension, congestive heart failure) as judged by the investigator
- •Involvement in the planning and conduct of the study
- •Previous enrolment or randomisation of treatment in the present study.
- •Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- •The cytochrome P450 3A4 inhibitors and inducers
- •A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- •Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) >8.5%.
- •Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
- •Not under physician care for DM
- •Physician responsible for patient's DM care has not indicated that patient's DM is controlled.
- •Physician responsible for patient's DM care has not approved patient's participation in the study
- •Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks.
- •Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks *Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
- •An absolute neutrophil count (ANC) of greater than 1.5 x 109/L
研究组 & 干预措施
Intervention group
Combined psychotherapy and pharmacological treatment
Open single arm 'pilot' clinical trial in patients with dissociative disorders, admitted to the psychiatric emergency unit of Geneva and in the Hogan Psychotherapeutic Center in Montreux.
Patients will be interviewed according to the Dissociative Experiences Scale (DES) and, if their score is 30 or higher, the Structured Clinical Interview for DSM-IV Dissociative Disorders (SCID) will be administered.
干预措施: Psychotherapy (Behavioral)
Intervention group
Combined psychotherapy and pharmacological treatment
Open single arm 'pilot' clinical trial in patients with dissociative disorders, admitted to the psychiatric emergency unit of Geneva and in the Hogan Psychotherapeutic Center in Montreux.
Patients will be interviewed according to the Dissociative Experiences Scale (DES) and, if their score is 30 or higher, the Structured Clinical Interview for DSM-IV Dissociative Disorders (SCID) will be administered.
干预措施: Pharmacological treatment (Quetiapine and/or Escitalopram) (Drug)
结局指标
主要结局
To study the efficacy of a specific combined treatment (psychotherapy and pharmacotherapy) on patients with dissociative disorders, in terms of patients with a favorable outcome by means of the DES scale.
时间窗: 8 weeks
次要结局
- The relationship between serum lipid levels and depressive symptoms in patients with dissociative disorder during combined treatment.(8 weeks)