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临床试验/NCT06967857
NCT06967857招募中2 期

Randomized, Placebo-controlled Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression (DEXAD)

Prof. Dr. Frank Behrens2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年5月15日最近更新:
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干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
105
试验地点
2
主要终点
Incidence of adverse events (AE) in the active treatment groups compared to the placebo until V6
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The indication of attention-deficit/hyperactivity disorder (ADHD) to be examined often occurs with other psychiatric disorders, and the majority of adults with ADHD have at least one psychiatric comorbidity in their lives. Depression is one of the most common comorbidities in patients with ADHD. The prevalence of comorbid depression in adults with ADHD is estimated to be as high as 50%.

There is evidence that stimulants such as dexamfetamine and methylphenidate lead to an improvement in sustained focused attention, working memory, and a variety of cognitive processes in the prefrontal cortex (PFC). In combination with the pharmacological effects of stimulants, such as the inhibition of monoamine oxidase, the increase in the concentration of noradrenaline in the PFC and dopamine in the striatum, dexamfetamine and methylphenidate could improve the treatment of depression in patients with major depressive disorder and comorbid ADHD.

This clinical trial will evaluate the safety and efficacy of DEX in two different formulations compared to placebo in adults with ADHD and moderate to severe depression. To ensure double blinding of the treatment, placebo will be administered in the form of tablets and capsules.

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 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of attention deficit / hyperactivity disorder (ADHD) (according to DSM-5 (fifth version of Diagnostic and Statistical Manual of Mental Disorders) or ICD (International Statistical Classification Of Diseases And Related Health Problems) guidelines) which started in childhood (at the age of <12 years)
  • •Patient has a minimum ADHS-Diagnostische Checkliste-Q (ADHS-DC) total score of 32 at baseline (Visit (V) 0)
  • •Moderate to severe depression according to ICD-10 (depressive episode: Code F32; recurrent depressive disorder: Code F33) and with a Montgomery-Åsberg Depression Rating Scale (MADRS) score of >20 at baseline (V0)
  • •CGI-S ≥ 4 at baseline (V0)
  • •Patients receiving selective serotonin reuptake inhibitors (SSRIs) or Serotonin-norepinephrine reuptake inhibitors (SNRIs) (stable doses within the last 2 weeks before inclusion) (≤40 mg (es)citalopram, 50-200 mg sertraline, 75 - 300 mg venlafaxine extended release)
  • •Male or female patients ≥ 18 years and ≤ 65 at time of enrolment
  • •Patients with QTc interval within normal ranges (≤470 ms in males and ≤480 ms in females)
  • •Patient is either free of stimulant medication or who, after discussion with his / her treating physician, is able and willing to discontinue the current psychotropic medication(s) for treatment of ADHD symptoms (specifically, methylphenidate, lisdexamfetamine, guanfacine or atomoxetine or any other medication approved for the treatment of ADHD) ) for the duration of the study, as well as is able and willing to discontinue all relevant co-medication according to exclusion criterion no. 20a-s for comorbid conditions during the clinical trial, if applicable
  • •Written informed consent and data protection declaration obtained prior to the initiation of any protocol required procedures
  • •Willing and able to comply to study procedures and study protocol

排除标准

  • •Current or a history of severe co-morbid symptoms such as psychotic symptoms, schizophrenia, bipolar disorders or manic episodes
  • •Current or recent history of substance abuse disorder within the last 6 months of clinical trial entry
  • •Patients with body mass index (BMI) < 18.5 kg/m² or >35 kg/m²
  • •History of serotonin syndrome events
  • •History of seizures or use of anticonvulsant medication
  • •Any other uncontrolled psychiatric condition that requires medication or may interfere with trial participation
  • •Known symptomatic cardiovascular disease including structural abnormalities, moderate and severe hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), heart failure, myocardial infarction, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, potentially life-threatening arrhythmias and channelopathies (diseases caused by ion channel dysfunction)
  • •Significant, in the discretion of the investigator, hepatic, gastrointestinal, renal, haematological or oncologic disorder
  • •Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma or porphyria
  • •Diagnosis or family history of Tourette's syndrome or dystonia
  • •Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke
  • •Immunodeficiency disorders (e.g. organ transplantation, Human Immunodeficiency Virus (HIV) infection)
  • •Known hypersensitivity to any of the ingredients of the trial medication, e.g. patients with known rare hereditary problems of fructose intolerance
  • •Males or females of reproductive potential not willing to use effective contraception (defined as PEARL index <1 - e.g. contraceptive pill, intrauterine device (IUD)) during the study period (Screening to Follow-up)
  • •Pregnancy and lactation
  • •Participation in another interventional clinical trial during the trial and within the previous 30 days prior to trial start
  • •Patients who are institutionalised by court order or regulatory action
  • •Patients, who are members of the staff of the trial centre, staff of the sponsor or involved Clinical Research Organisation (CRO), the investigator him- / herself or close relatives of the investigator
  • •Legal incapacity and/ or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial
  • •Current use of and use within the last 2 weeks before inclusion due to possible interactions with stimulants or SSRIs/SNRIs and possible resulting or expected side effects:
  • •Antipsychotics (such as chlorpromazine, haloperidol, thioridazine; except for quetiapine up to 100mg/day)
  • •SSRIs and SNRIs daily doses of >40 mg (es)citalopram, >200 mg sertraline, >300 mg venlafaxine extended release
  • •Monoamine oxidase inhibitors (MAO) inhibitors
  • •tricyclic antidepressants
  • •benzodiazepines (including Z-drugs)
  • •atypical antidepressants (with an exception for daily doses of 100-300 mg trazodone)
  • •Dopamine reuptake inhibitors (special restriction for bupropion)
  • •antiarrhythmics (Class IA and III)
  • •antibiotics (in particular macrolides and fluoroquinolones, linezolid)
  • •hydroxychloroquine, chloroquine
  • •ketoconazole
  • •acetylsalicylic acid (dose up to 300 mg allowed)
  • •diphenhydramine
  • •budesonide / formoterol
  • •albuterol / salbutamol

研究组 & 干预措施

DEX IR

Experimental

tablets twice daily

干预措施: DEX IR tablets (Drug)

DEX XL

Experimental

capsule once daily

干预措施: DEX XL (Drug)

PLC

Placebo Comparator

tablet or capsule as comparator to verum

干预措施: Placebo (Drug)

结局指标

主要结局

Incidence of adverse events (AE) in the active treatment groups compared to the placebo until V6

时间窗: from enrollment to the end of study at week 17

Incidence of adverse events (AE) in the active treatment groups (DEX XL and DEX IR) compared to the placebo until V6

次要结局

  • Incidence of adverse events (AE) until V5(Start with enrollment until end of treatment at Week 16)
  • Proportion of patients with at least one AE until V5(through study treatment (up to 16 weeks))
  • Proportion of patients with at least one AE until end of study(from baseline until end of study at week 17)
  • Number of AE until V5(through study treatment (up to 16 weeks))
  • Number of AE until V5 and until end of study(from baseline until end of study at week 17)
  • Number of AE/SAE during the study period(through study treatment (up to 16 weeks))
  • number of patients with AE/SAE by type during study period(through study treatment (up to 16 weeks))
  • proportion of patients with AE/SAE by type during study period(through study treatment (up to 16 weeks))
  • number of patients with AE/SAE by severity (mild, moderate, severe) during study period(through study treatment (up to 16 weeks))
  • proportion of patients with AE/SAE by severity (mild, moderate, severe) during study period(through study treatment (up to 16 weeks))
  • number of patients with AE/SAE by relatedness to treatment during study period(through study treatment (up to 16 weeks))
  • proportion of patients with AE/SAE by relatedness to treatment during study period(from enrollment to the end of study at week 17)
  • Score of clinical global impression (CGI) Efficacy index by investigator at Visit 5(16 weeks after treatment start)
  • Number of patients with early withdrawal from therapy due to adverse events(baseline until end of treatment at week 16 (12 weeks after end of titration phase))
  • MADRS suicidal ideation score for all available visits (screening to Visit 5)(from enrollment to the end of treatment (up to week 16))
  • MADRS suicidal ideation score for all available visits(from enrollment to baseline (start of treatment, V0))
  • MADRS suicidal ideation score change to BL/V0 (on V1)(from baseline to end of treatment titration phase at 4 weeks)
  • MADRS suicidal ideation score change to BL/V0 (on V5)(from treatment start to end of treatment at 16 weeks)
  • MADRS suicidal ideation score for all available visits (screening to visit 5)(from enrollment to 16 weeks (V5))
  • Rate of patients with score 1-3 in CGI-I at V5(from baseline to 16 weeks (V5))
  • Absolute scores categories of CGI-I at all available visits(from end of treatment titration phase at 4 weeks (V1) to week 7 (V2))
  • Absolute scores categories of CGI-I at all available visits (V1 to V2)(from end of titration phase (week 4) to 7 weeks (V2))
  • Absolute scores categories of CGI-I at all available visits (V1 to V3)(from end of titration phase (week 4) to 10 weeks (V3))
  • Absolute scores categories of CGI-I at all available visits (V1 to V4)(from end of titration phase (week 4) to 13 weeks (V4))
  • Absolute scores categories of CGI-I at all available visits (V1 to V5)(from end of titration phase (week 4) to end of treatment at 16 weeks (V5))
  • Number of patients with early withdrawal from therapy due to adverse events per treatment group(baseline until end of treatment at week 16 (12 weeks after end of titration phase))
  • MADRS total score (range 0-60) for all available visits (SCR to V5)(Screening until end of treatment at week 16 (V5))
  • Numbers and percentages of patients with (1) decreased, (2) maintained and (3) increased CGI-S at V5 compared to BL/V0(from baseline to end of treatment at 16 weeks (V5))
  • Shift table of CGI-S score categories at BL/V0(at baseline)
  • Shift table of CGI-S score categories at V1(from baseline to end of treatment titration phase at 4 weeks (V1))
  • Shift table of CGI-S score categories at V5(from baseline to end of treatment at 16 weeks (V5))
  • Absolute score categories of CGI-S at V0(at baseline (V0))
  • Absolute score categories of CGI-S at V0 to V2(from baseline to 7 weeks (V2))
  • Absolute score categories of CGI-S at V0 to V1(from baseline to end of treatment titration phase at 4 weeks (V1))
  • Absolute score categories of CGI-S at V0 to V3(from baseline to 10 weeks (V3))
  • Absolute score categories of CGI-S at V0 to V4(from baseline to 13 weeks (V4))
  • Absolute score categories of CGI-S at V0 to V5(from baseline to end of treatment at 16 weeks (V5))
  • MADRS total score (range 0-60) MADRS total score (range 0-60) change to BL/V0 (at V5)(baseline until end of treatment at week 16 (V5))
  • MADRS total score categorization by Müller et al. at BL/ V0(at baseline)
  • ADHS-DC-Q total score (range 0-66) for all available visits (SCR to V5)(Screening to end of treatment at week 16)
  • ADHS-DC-Q total score (range 0-66) change to BL/V0 (V1)(baseline until end of titration phase at week 4 (V1))
  • QIDS-SR-16 total score (range 0-27) for all available visits (V0 to V5)(baseline to end of treatment at 16 weeks)
  • QIDS-SR-16 total score (range 0-27) change to BL/V0 (V5)(from baseline to end of treatment at week 16 (V5))
  • Mean dose intake from V1 to V5 per treatment group(from end of titration (week 4, V1) until end of treatment at week 16)
  • Mean dose intake compared to planned dose after titration phase (for study period V1 to V5) per treatment group(end of titration phase (visit 1) 4 weeks after baseline until end of treatment at week 16 (12 weeks after titration phase))
  • Proportion of patients with less than 80% of planned dose intake (for study period V1 to V5) per treatment group(visit 1 (4 weeks after baseline) until end of treatment at week 16)
  • Number of patients by dosage group at V1 and V2(at visit 1 (4 weeks after baseline) and at visit 2 (3 weeks after visit 1))
  • Proportion of patients by dosage group at V1 and V2(at visit 1 (4 weeks after baseline) and at visit 2 (3 weeks after visit 1))
  • Number of patients per treatment group that needed dose optimization of IMP in the optimal stable dose phase and type of optimization (e.g., downtitration)(end of titration phase (visit 1) 4 weeks after baseline until end of treatment at week 16 (12 weeks after titration phase))
  • Proportion of patients per treatment group that needed dose optimization of IMP in the optimal stable dose phase and type of optimization (e.g., downtitration)(end of titration phase (visit 1) 4 weeks after baseline until end of treatment at week 16 (12 weeks after titration phase))
  • percentage of patients with early withdrawal from therapy due to adverse events in total(baseline until end of treatment at week 16 (12 weeks after end of titration phase))
  • Percentage of patients with early withdrawal from therapy due to adverse events per treatment group(baseline until end of treatment at week 16 (12 weeks after end of titration phase))
  • MADRS total score categorization by Müller et al. at BL/ V0, V1 and V5(at baseline, at end of titration phase (week 4) and at end of treatment (week 16, V5))
  • MADRS total score (range 0-60) MADRS total score (range 0-60) change to BL/V0 (at V1)(baseline until end of titration phase at week 4 (V1))
  • ADHS-DC-Q total score (range 0-66) change to BL/V0 (to V5)(baseline until end of treatment at week 16 (V5))
  • QIDS-SR-16 total score (range 0-27) change to BL/V0 (V1)(from baseline to end of titration (week 4, V1))
  • MADRS suicidal ideation score for all available visits(from enrollment to end of titration at week 4 (V1))
  • MADRS suicidal ideation score for all available visits(from enrollment to week 7 (V2))
  • MADRS suicidal ideation score for all available visits(from enrollment to 10 weeks (V3))
  • MADRS suicidal ideation score for all available visits(from enrollment to 13 weeks (V4))
  • ADHS-DC-Q total score (range 0-66) change to BL/V0 (V1)(from baseline to end of titration at week 4 (V1))

研究者

发起方
Prof. Dr. Frank Behrens
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dr. Frank Behrens

Deputy Head of Institute, Clinical Professor, Head of Department of Clinical Research at ITMP

Fraunhofer Institute for Translational Medicine and Pharmacology ITMP

研究点 (2)

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