Could a common ADHD drug also treat depression?
NCT ID NCT06967857
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tests whether dexamfetamine, a stimulant used for ADHD, can safely and effectively treat both ADHD and moderate to severe depression in adults. 105 participants will receive either a fast-acting or long-acting version of the drug, or a placebo. The study is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dexamfetamine sulfate
- What this could lead to
- If successful, this could point toward a new treatment option for people with both ADHD and depression, potentially improving focus and mood together.
- What could go wrong
- This is an early Phase 2 trial with only 105 participants, so results may not apply to everyone. Stimulants can cause side effects like insomnia, anxiety, or increased heart rate.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 105 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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) 2. Patient has a minimum ADHS-Diagnostische Checkliste-Q (ADHS-DC) total score of 32 at baseline (Visit (V) 0) 3. 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) 4. CGI-S ≥ 4 at baseline (V0) 5. 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) 6. Male or female patients ≥ 18 years and ≤ 65 at time of enrolment 7. Patients with QTc interval within normal ranges (≤470 ms in males and ≤480 ms in females) 8. 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 9. Written informed consent and data protection declaration obtained prior to the initiation of any protocol required procedures 10. Willing and able to comply to study procedures and study protocol Exclusion Criteria: 1. Current or a history of severe co-morbid symptoms such as psychotic symptoms, schizophrenia, bipolar disorders or manic episodes 2. Current or recent history of substance abuse disorder within the last 6 months of clinical trial entry 3. Patients with body mass index (BMI) \< 18.5 kg/m² or \>35 kg/m² 4. History of serotonin syndrome events 5. History of seizures or use of anticonvulsant medication 6. Any other uncontrolled psychiatric condition that requires medication or may interfere with trial participation 7. 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) 8. Significant, in the discretion of the investigator, hepatic, gastrointestinal, renal, haematological or oncologic disorder 9. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma or porphyria 10. Diagnosis or family history of Tourette's syndrome or dystonia 11. Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke 12. Immunodeficiency disorders (e.g. organ transplantation, Human Immunodeficiency Virus (HIV) infection) 13. Known hypersensitivity to any of the ingredients of the trial medication, e.g. patients with known rare hereditary problems of fructose intolerance 14. 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) 15. Pregnancy and lactation 16. Participation in another interventional clinical trial during the trial and within the previous 30 days prior to trial start 17. Patients who are institutionalised by court order or regulatory action 18. 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 19. Legal incapacity and/ or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial 20. 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: 1. Antipsychotics (such as chlorpromazine, haloperidol, thioridazine; except for quetiapine up to 100mg/day) 2. SSRIs and SNRIs daily doses of \>40 mg (es)citalopram, \>200 mg sertraline, \>300 mg venlafaxine extended release 3. Monoamine oxidase inhibitors (MAO) inhibitors 4. tricyclic antidepressants 5. benzodiazepines (including Z-drugs) 6. atypical antidepressants (with an exception for daily doses of 100-300 mg trazodone) 7. Dopamine reuptake inhibitors (special restriction for bupropion) 8. antiarrhythmics (Class IA and III) 9. antibiotics (in particular macrolides and fluoroquinolones, linezolid) 10. opioids 11. hydroxychloroquine, chloroquine 12. ketoconazole 13. acetylsalicylic acid (dose up to 300 mg allowed) 14. diphenhydramine 15. apixaban 16. metoprolol 17. pregabalin 18. budesonide / formoterol 19. albuterol / salbutamol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Psychiatry, Psychosomatics and Psychotherapy University Hospital Frankfurt am Main - Goethe University
RECRUITINGFrankfurt, 60590, Germany
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University Leipzig, Department of Psychiatry and Psychotherapy
RECRUITINGLeipzig, 04103, Germany
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