Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression

NCT06967857 | Recruiting Phase 2 DMC

• 1 other identifier: TMP-18122023-58
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD); Depression - Major Depressive Disorder

Keywords

ADHD; Depression; Adults

Outcome Measures

Primary Outcomes (1)

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

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

  from enrollment to the end of study at week 17

Secondary Outcomes (61)

• 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

Study Arms (3)

DEX IR

EXPERIMENTAL

tablets twice daily

Drug: DEX IR tablets

DEX XL

EXPERIMENTAL

capsule once daily

Drug: DEX XL

PLC

PLACEBO COMPARATOR

tablet or capsule as comparator to verum

Drug: Placebo

Interventions

DEX IR tablets DRUG

tablet twice daily

DEX IR

DEX XL DRUG

capsule once daily

DEX XL

Placebo DRUG

Placebo to either capsule or tablet

PLC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)
• 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

You may not qualify 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) \< 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

Sponsors & Collaborators

• Prof. Dr. Frank Behrens: lead

Study Sites (2)

Department of Psychiatry, Psychosomatics and Psychotherapy University Hospital Frankfurt am Main - Goethe University

Frankfurt, 60590, Germany

RECRUITING

University Leipzig, Department of Psychiatry and Psychotherapy

Leipzig, 04103, Germany

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Depression

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Andreas Reif, Prof. Dr. med.

  Department of Psychiatry, Psychosomatics and Psychotherapy University Hospital Frankfurt am Main - Goethe University

  STUDY CHAIR

Central Study Contacts

Christin Jonetzko

CONTACT

+49 69 630180210; christin.jonetzko@itmp.fraunhofer.de

Anja Kuehne

CONTACT

anja.kuehne@itmp.fraunhofer.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Head of Institute, Clinical Professor, Head of Department of Clinical Research at ITMP

Model Details: randomised, double blind

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 13, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

DE (2)