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Tests treatment safety and results for Attention-Deficit/Hyperactivity Disorder (ADHD)
Official title Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression
ClinicalTrials.gov ID: NCT06967857
What this study is testing
What is DEX IR tablets?
DEX IR tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for attention-deficit/hyperactivity disorder (adhd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Diagnosis of attention deficit / hyperactivity disorder (ADHD) (according to DSM-5 (fifth version of Diagnostic and Statistical Manual of Mental...
- 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...
- CGI-S ≥ 4 at baseline (V0)
- Patients receiving selective serotonin reuptake inhibitors (SSRIs) or Serotonin-norepinephrine reuptake inhibitors (SNRIs) (stable doses within the...
You likely can't join if
- 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) \ 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
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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
- 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) \ 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...
- 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 treatment 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)
- opioids
- hydroxychloroquine, chloroquine
- ketoconazole
- acetylsalicylic acid (dose up to 300 mg allowed)
- diphenhydramine
- apixaban
- metoprolol
- pregabalin
- budesonide / formoterol
- albuterol / salbutamol
The study team makes the final eligibility decision.
Where it's taking place
- Frankfurt, Germany
- Leipzig, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frankfurt, Germany; Leipzig, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.