Lack of Efficacy of Psychological and Pharmacological Treatments of Eating Disorders: Neurobiological Background
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- change in brain secretion of Dopamine at 6 months
研究概览
简要总结
Background. Treatments of eating disorders result too often in partial psychological and physical remission, chronic course, dropout, relapse and death, with no fully known explanations for this failure. In order to clarify this problem, we conducted a three branches study to identify the biochemical background of cognitive-behavioral psychotherapy (CBT), individual psychology brief psychotherapy (IBPP), and psychotherapy-pharmacotherapy with CBT+olanzapine in anorexics (AN) and bulimics (BN) by measuring the levels of plasma homovanillic acid (HVA) for dopamine secretion, plasma 3-methoxy-4-hydroxy-phenylglycol (MHPG) for noradrenalin secretion, and platelet [3 Hydrogen]-Paroxetine-binding Bmax and Kd for serotonin transporter function. The data were then compared with psychopathological and physical alterations. Methods. Branch 1 investigated the effects of 4 months of CBT on plasma HVA, MHPG and [3 Hydrogen]-Par-binding in 14 AN-restricted, 14 AN-bingeing/purging, and 22 BN inpatients. Branch 2 investigated the effects of 4 months of IBPP on plasma HVA in 15 AN and 17 BN outpatients. Branch 3 investigated the effect of 3 months of CBT+olanzapine (5 mg/day) in 30 AN outpatients. The data are analyzed using one-way ANOVA for repeated measures for the changes between basal and post-treatment biological and psychological parameters, two-way ANOVA for repeated measures for the differences in the psychobiological data in the 3 groups, Spearman's test for the correlations between basal and final changes in the psychological and biological scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •eating disorders full diagnosis according to Diagnostic and Statistical Manual (DSM-IV)
- •age between 15 and 35
- •female gender
排除标准
- •associated major psychiatric problems
- •mental retardation
研究组 & 干预措施
CBT (Cognitive Behavioral Therapy)
Investigates the effects of cognitive-behavioral therapy (CBT), on the secretion of brain dopamine (DA), noradrenalin (NE) and serotonin (5-HT) in a group of 50 female inpatients, 14 with AN restricter type (AN-R), 14 with the bingeing-purging type (AN-BP), and 22 with BN.
Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation
干预措施: CBT (Cognitive Behavioral Therapy) (Behavioral)
CBT (Cognitive Behavioral Therapy)
Investigates the effects of cognitive-behavioral therapy (CBT), on the secretion of brain dopamine (DA), noradrenalin (NE) and serotonin (5-HT) in a group of 50 female inpatients, 14 with AN restricter type (AN-R), 14 with the bingeing-purging type (AN-BP), and 22 with BN.
Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation
干预措施: nutritional rehabilitation (Dietary Supplement)
CBT (Cognitive Behavioral Therapy)
Investigates the effects of cognitive-behavioral therapy (CBT), on the secretion of brain dopamine (DA), noradrenalin (NE) and serotonin (5-HT) in a group of 50 female inpatients, 14 with AN restricter type (AN-R), 14 with the bingeing-purging type (AN-BP), and 22 with BN.
Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation
干预措施: delorazepam (Drug)
IBPP (IP brief psychotherapy )
Investigates the effects in 15 AN and 17 BN patients of an individual psychology brief psychotherapy (IBPP) on psychological alterations and DA secretion measured as peripheral blood values of HVA before and after treatment.
Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation.
干预措施: IBPP (individual psychology brief psychotherapy) (Other)
IBPP (IP brief psychotherapy )
Investigates the effects in 15 AN and 17 BN patients of an individual psychology brief psychotherapy (IBPP) on psychological alterations and DA secretion measured as peripheral blood values of HVA before and after treatment.
Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation.
干预措施: nutritional rehabilitation (Dietary Supplement)
IBPP (IP brief psychotherapy )
Investigates the effects in 15 AN and 17 BN patients of an individual psychology brief psychotherapy (IBPP) on psychological alterations and DA secretion measured as peripheral blood values of HVA before and after treatment.
Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation.
干预措施: delorazepam (Drug)
CBT + OLANZAPINE (5 MG)
The study evaluated in 18 AN-R and 12 AN-BP patients the effects of CBT and of CBT associated with orally administered 5 mg olanzapine on the psychopathological aspects of the disease and on the secretion of HVA.
Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation
干预措施: CBT + OLANZAPINE (Drug)
CBT + OLANZAPINE (5 MG)
The study evaluated in 18 AN-R and 12 AN-BP patients the effects of CBT and of CBT associated with orally administered 5 mg olanzapine on the psychopathological aspects of the disease and on the secretion of HVA.
Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation
干预措施: nutritional rehabilitation (Dietary Supplement)
CBT + OLANZAPINE (5 MG)
The study evaluated in 18 AN-R and 12 AN-BP patients the effects of CBT and of CBT associated with orally administered 5 mg olanzapine on the psychopathological aspects of the disease and on the secretion of HVA.
Associated intervention (non of interest): psychiatric management (with tranquillizer: delorazepam), nutritional rehabilitation
干预措施: delorazepam (Drug)
结局指标
主要结局
change in brain secretion of Dopamine at 6 months
时间窗: 6 months
plasma homovanillic acid (HVA) measured before and after the therapeutic intervention in each branch.
change in brain secretion of Noradrenaline at 6 months
时间窗: 6 months
plasma 3-methoxy-4-hydroxyphenylglycol (MHPG) measured before and after the therapeutic intervention in each branch
change in brain secretion of serotonin at 6 months
时间窗: 6 months
the platelet paroxetine binding (\[3 Hydrogen\]-Par-binding): Bmax (maximum binding capacity) and Kd (dissociation constant) measured before and after the therapeutic intervention in each branch.
次要结局
- Depressive Psychopathology improvement after 6 months(6 months)
- Impulsiveness improvement after 6 months(6 months)
- Eating Psychopathology improvement after treatments at 6 months(6 months)
- Anxiety improvement after 6 months(6 months)
- Self-rated Biochemical improvement after 6 months(6 months)
- Personality improvement after 6 months(6 months)
研究者
Federico Amianto
Dottor
University of Turin, Italy