Anorexia in Adolescence Clinical Trial
Official title:
New Treatment Perspectives in Adolescents With Anorexia Nervosa: the Efficacy of Non-invasive Brain-directed Treatment
The present randomized, double blind, placebo-controlled trial aims at evaluating the efficacy of a tDCS treatment in improving the clinical outcome of adolescents with AN and investigate brain mechanisms acting in AN.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | January 30, 2025 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | Inclusion Criteria: - diagnosis of AN according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition - DSM-5 (American Psychiatric Association & American Psychiatric Association, 2013); - condition of under-weight (BMI <18.5 kg/m2); - intelligence quotient higher or equal to 85 (IQ = 85); - ability to give informed consent under parents' surveillance and guidance Exclusion Criteria: - a personal history of neurological/medical/genetic diseases; - a personal history of epilepsy; - suicide risk; - receiving CNS-active drug, other counseling or psychological therapies during the treatment. |
Country | Name | City | State |
---|---|---|---|
Italy | Bambino Gesù Hospital and Research Institute | Rome |
Lead Sponsor | Collaborator |
---|---|
Bambino Gesù Hospital and Research Institute |
Italy,
Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15. — View Citation
Costanzo F, Menghini D, Maritato A, Castiglioni MC, Mereu A, Varuzza C, Zanna V, Vicari S. New Treatment Perspectives in Adolescents With Anorexia Nervosa: The Efficacy of Non-invasive Brain-Directed Treatment. Front Behav Neurosci. 2018 Jul 20;12:133. do — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary end-point of the study is the variance on eating psychopathology at T1, assessed as changes in Eating Disorder Risk score (EDRC) of the Eating Disorder Inventory (EDI-3). Significant changes in Ineffectiveness (IC) of the EDI-3. | EDI-3 comprises 91-item that give a measure of the basic characteristics of the ED through six composite scores [Eating Disorder Risk (EDRC) (range 0-100), Ineffectiveness (IC) (range 0-48), Interpersonal Problems (IPC) (range 0-52), Affective Problems (APC) (range 0-62), Overcontrol (OC) (range 0-52), and General Psychological Maladjustment (GPMC) (range 0-252)]. Higher scores indicates more severe problems. | 6 weeks | |
Secondary | Significant changes in Ineffectiveness (IC) of the EDI-3. | Evaluation of the change in Ineffectiveness, with maximum possible score of 48, where higher scores indicate higher Ineffectiveness. | 12 months follow up | |
Secondary | Significant changes in Interpersonal Problems (IPC) of the EDI-3. | Evaluation of the change in Interpersonal Problems, with maximum possible score of 52, where higher scores indicate higher Interpersonal Problems. | 12 months follow up | |
Secondary | Significant changes in Affective Problems (APC) of the EDI-3. | Evaluation of the change in Affective Problems, with maximum possible score of 62, where higher scores indicate higher Affective Problems. | 12 months follow up | |
Secondary | Significant changes in Overcontrol (OC) of the EDI-3. | Evaluation of the change in Overcontrol, with maximum possible score of 52, where higher scores indicate higher Overcontrol. | 12 months follow up | |
Secondary | Significant changes in General Psychological Maladjustment (GPMC) of the EDI-3. | Evaluation of the change in General Psychological Maladjustment, with maximum possible score of 252, where higher scores indicate higher General Psychological Maladjustment. | 12 months follow up | |
Secondary | Significant changes in the total scores of AN symptomatology measures as Eating Attitudes Test (EAT-26) | The EAT-26 proposes a cut-off score of 20. Scores of 20 or higher were considered clinically significant. | 12 months follow up | |
Secondary | Significant changes in the total scores of AN symptomatology measures as Body Uneasiness Test (BUT). | The BUT proposes a cut-off score of 1,2. Scores of 1,2 or higher were considered clinically significant. | 12 months follow up | |
Secondary | Significant changes in the total scores of other psychopathological measures as Child Behavior Checklist (CBCL 6-18). | The CBCL 6-18 generates a T-score for each subscale. According to normative data, a T-score above 64 was considered to be significant for the 3 broadband scales, whereas for the syndrome scales, the cut-off for clinical significance was 70. | 12 months follow up | |
Secondary | Significant changes in the total scores of other psychopathological measures as Children's Depression Inventory (CDI). | Raw scores were converted to T-scores. According to normative data, a T-score above 64 was considered clinical significance. | 12 months follow up | |
Secondary | Significant changes in the total scores of other psychopathological measures as Multidimensional Anxiety Scale for Children (MASC). | Raw scores were converted to T-scores. According to normative data, a T-score above 64 was considered clinical significance. | 12 months follow up | |
Secondary | Significant changes in the physiological measures specifically the BMI index | 12 months follow up | ||
Secondary | Number of participants with abnormal laboratory blood test results. | 12 months follow up | ||
Secondary | Significant changes in the endogenous stress response, measured with Cortisol Awakening Response (CAR). | 12 months follow up | ||
Secondary | Significant changes in intra-cortical inhibitory/excitatory motor circuits using paired pulse TMS, measured as short intracortical inhibition and facilitation. | the ratio between MEPs amplitude conditioning stimulus and MEPs amplitude test stimulus alone for each ISI. | 6 weeks | |
Secondary | Significant changes in sensory-motor integration using paired pulse TMS, measured as SICI/ICF: the ratio between MEPs amplitude (mV) conditioning stimulus (electrical stimulation) and MEP amplitude test stimulus alone for each ISI. | 6 weeks | ||
Secondary | Significant changes in cortical oscillatory patterns (synchronization and desynchronization) in theta, alpha and beta frequencies (Hz) over motor and premotor cortex, using TMS-EEG co-registration. | 6 weeks | ||
Secondary | Significant changes in cortical connectivity using TMS-EEG co-registration combined to report the analysis of the waveform, latency and cortical distribution of TMS-evoked potentials (TEPs) in micronV. | 6 weeks | ||
Secondary | Significant changes in cortical reactivity in terms of TMS-evoked potentials (TEPs) amplitude for time domain (micronV) and frequency bands for spatial domain (Hz), using TMS-EEG co-registration. | 6 weeks | ||
Secondary | Significant changes in Cortical Plasticity evoked by repetitive TMS in terms of different MEP amplitude (mV) recorded at different time-points after repetitive TMS perturbations. | 6 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06244576 -
Emotional Dysregulation, Maladaptive Overcontrol in Anorexia - Effect of Radically Open Dialectical Behaviour Therapy
|
N/A | |
Completed |
NCT03097874 -
Adaptive Treatment for Adolescent Anorexia Nervosa
|
N/A | |
Recruiting |
NCT05057000 -
Effect of Aerobic Exercises and Nutrition In Adolescent Girls With Anorexia
|
N/A | |
Recruiting |
NCT05418075 -
Evaluation of the Effectiveness of Add-on Hometreatment to Family Based Therapy in Adolescent Anorexia Nervosa.
|
N/A | |
Recruiting |
NCT06097247 -
Family Functioning and Adverse Side Effects of Family-based Therapy for Anorexia Nervosa
|
||
Recruiting |
NCT05235867 -
Secretin in Refeeding
|
||
Not yet recruiting |
NCT05249140 -
Finding Treatments for Eating Disorders
|
N/A | |
Terminated |
NCT05073679 -
Oral Naltrexone In Pediatric Eating Disorders
|
Phase 2/Phase 3 |