Attention-Deficit/Hyperactivity Disorder (ADHD)Phase 2DEXADNCT06967857
Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression
A Phase 2 study testing DEX IR tablets and DEX XL in people with Attention-Deficit/Hyperactivity Disorder (ADHD) and Depression - Major Depressive Disorder, run by Prof. Dr. Frank Behrens at 5 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder (ADHD), Depression - Major Depressive Disorder
- What is being tested?
- DEX IR tablets and DEX XL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 5 sitesGermany
- Study dates
- 15 May 2025to Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
- opioids
- hydroxychloroquine, chloroquine
- ketoconazole
- acetylsalicylic acid (dose up to 300 mg allowed)
- diphenhydramine
- apixaban
- metoprolol
- pregabalin
- budesonide / formoterol
- albuterol / salbutamol
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anja Kuehne contact
5 sites in 1 country
Germany5 sites, 5 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin
Berlin, 12203
Julian Hellmann-Regen, PD Dr. med., 00 49 30 517 509, adhs-spezialambulanz@charite.de
- Recruiting
Universitätsklinikum Bonn AöR, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Bonn, 53127
Alexandra Philipsen, Prof. Dr. med., 00 49 228 287 31221, claudia.hanses@ukbonn.de
Claudia Hanses, 00 49 228 287 31221, claudia.hanses@ukbonn.de
- Recruiting
Department of Psychiatry, Psychosomatics and Psychotherapy University Hospital Frankfurt am Main - Goethe University
Frankfurt, 60590
Andreas Reif, Prof. Dr. med., +49 69 6301 5222, reif@med.uni-frankfurt.de
Andreas Reif, Prof. Dr. med
- Recruiting
University Leipzig, Department of Psychiatry and Psychotherapy
Leipzig, 04103
Maria Strauss, Prof. Dr. med., +49 341 - 97 24334, Maria.Strauss@medizin.uni-leipzig.de
Maria Strauss, Prof. Dr. med.
- Recruiting
LMU Klinikum München Klinik für Psychiatrie und Psychotherapie
München, 80336
Oliver Pogarell, Prof. Dr. med., 00 49 89 4400-55540, PSY.DEXAD-Studie-LMU@med.uni-muenchen.de
Oliver Pogarell, Prof. Dr. med.
About this study
Official title: 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)
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.
- Being tested
- DEX IR tablets, DEX XL, Placebo
- Keywords
- ADHD, Depression, Adults
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEX IR tabletsDrug
tablet twice daily
DEX XLDrug
capsule once daily
PlaceboDrug
Placebo to either capsule or tablet
| Study group | Role | What they receive |
|---|---|---|
| DEX IR | Experimental | tablets twice daily Receives: Drug: DEX IR tablets |
| DEX XL | Experimental | capsule once daily Receives: Drug: DEX XL |
| PLC | Placebo comparator | tablet or capsule as comparator to verum Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from enrollment to the end of study at week 17
Secondary outcomes (61)
Incidence of adverse events (AE) until V5
Dokumentation of AE
Measured: Start with enrollment until end of treatment at Week 16
Proportion of patients with at least one AE until V5
Proportion of patients with at least one AE until V5
Measured: through study treatment (up to 16 weeks)
Proportion of patients with at least one AE until end of study
Proportion of patients with at least one AE until end of study
Measured: from baseline until end of study at week 17
Number of AE until V5
Number of AE
Measured: through study treatment (up to 16 weeks)
Number of AE until V5 and until end of study
Number of AE
Measured: from baseline until end of study at week 17
Number of AE/SAE during the study period
Number of AE/SAE
Measured: through study treatment (up to 16 weeks)
number of patients with AE/SAE by type during study period
Number and type of AE/SAE
Measured: through study treatment (up to 16 weeks)
proportion of patients with AE/SAE by type during study period
Proportion of patient with AE/SAE by type
Measured: through study treatment (up to 16 weeks)
number of patients with AE/SAE by severity (mild, moderate, severe) during study period
number of patients with AE/SAE by severity (mild, moderate, severe)
Measured: through study treatment (up to 16 weeks)
proportion of patients with AE/SAE by severity (mild, moderate, severe) during study period
proportion of patients with AE/SAE by severity (mild, moderate, severe)
Measured: through study treatment (up to 16 weeks)
number of patients with AE/SAE by relatedness to treatment during study period
number of patients with AE/SAE by relatedness to treament
Measured: through study treatment (up to 16 weeks)
proportion of patients with AE/SAE by relatedness to treatment during study period
proportion of patients with AE/SAE by relatedness to treatment
Measured: from enrollment to the end of study at week 17
Score of clinical global impression (CGI) Efficacy index by investigator at Visit 5
Clinical global impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in patients with mental disorders. It is a brief 3-item observer-rated scale. 4×4 rating scale that assesses the therapeutic effect of treatment with psychiatric medication and associated side effects. Treatment is evaluated from "marked improvement" to "none/worsening". Side effects is evaluated from "none" to "outweigh therapeutic effect"
Measured: 16 weeks after treatment start
MADRS suicidal ideation score for all available visits (screening to Visit 5)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: from enrollment to the end of treatment (up to week 16)
MADRS suicidal ideation score for all available visits
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: from enrollment to end of titration at week 4 (V1)
MADRS suicidal ideation score for all available visits
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: from enrollment to week 7 (V2)
MADRS suicidal ideation score change to BL/V0 (on V1)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: from baseline to end of treatment titration phase at 4 weeks
MADRS suicidal ideation score change to BL/V0 (on V5)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: from treatment start to end of treatment at 16 weeks
MADRS suicidal ideation score for all available visits
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: from enrollment to 10 weeks (V3)
MADRS suicidal ideation score for all available visits
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: from enrollment to 13 weeks (V4)
MADRS suicidal ideation score for all available visits (screening to visit 5)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: from enrollment to 16 weeks (V5)
Rate of patients with score 1-3 in CGI-I at V5
The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians ask: "Compared to the patient's condition at baseline, this patient's [average] condition has...?" and rated as:
Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Measured: from baseline to 16 weeks (V5)
Absolute scores categories of CGI-I at all available visits
The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians ask: "Compared to the patient's condition at baseline, this patient's [average] condition has...?" and rated as:
Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Measured: 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)
The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians ask: "Compared to the patient's condition at baseline, this patient's [average] condition has...?" and rated as:
Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Measured: from end of titration phase (week 4) to 7 weeks (V2)
Absolute scores categories of CGI-I at all available visits (V1 to V3)
The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians ask: "Compared to the patient's condition at baseline, this patient's [average] condition has...?" and rated as:
Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Measured: from end of titration phase (week 4) to 10 weeks (V3)
Absolute scores categories of CGI-I at all available visits (V1 to V4)
The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians ask: "Compared to the patient's condition at baseline, this patient's [average] condition has...?" and rated as:
Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Measured: from end of titration phase (week 4) to 13 weeks (V4)
Absolute scores categories of CGI-I at all available visits (V1 to V5)
The clinical global impression - improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians ask: "Compared to the patient's condition at baseline, this patient's [average] condition has...?" and rated as:
Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse
Measured: from end of titration phase (week 4) to end of treatment at 16 weeks (V5)
Numbers and percentages of patients with (1) decreased, (2) maintained and (3) increased CGI-S at V5 compared to BL/V0
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are:
Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Measured: from baseline to end of treatment at 16 weeks (V5)
Shift table of CGI-S score categories at BL/V0
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are:
Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Measured: at baseline
Shift table of CGI-S score categories at V1
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are:
Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Measured: from baseline to end of treatment titration phase at 4 weeks (V1)
Shift table of CGI-S score categories at V5
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are:
Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Measured: from baseline to end of treatment at 16 weeks (V5)
Absolute score categories of CGI-S at V0
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are:
Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Measured: at baseline (V0)
Absolute score categories of CGI-S at V0 to V2
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are:
Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Measured: from baseline to 7 weeks (V2)
Absolute score categories of CGI-S at V0 to V1
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are:
Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Measured: from baseline to end of treatment titration phase at 4 weeks (V1)
Absolute score categories of CGI-S at V0 to V3
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are:
Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Measured: from baseline to 10 weeks (V3)
Absolute score categories of CGI-S at V0 to V4
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are:
Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Measured: from baseline to 13 weeks (V4)
Absolute score categories of CGI-S at V0 to V5
The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Clinicians ask: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" Possible ratings are:
Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients
Measured: from baseline to end of treatment at 16 weeks (V5)
MADRS total score (range 0-60) for all available visits (SCR to V5)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: Screening until end of treatment at week 16 (V5)
MADRS total score (range 0-60) MADRS total score (range 0-60) change to BL/V0 (at V5)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: baseline until end of treatment at week 16 (V5)
MADRS total score categorization by Müller et al. at BL/ V0
MADRS total score categorization by Müller et al.: 0-6 absence of symptoms; 7-19 mild depression, 20-34 moderate depression, 35-60 indicate a severe depression.
Measured: at baseline
ADHS-DC-Q total score (range 0-66) for all available visits (SCR to V5)
The ADHS-DC-Q consists of 18 items with a four-level response (not existing, slightly existing, moderately existing, strongly existing). The items ask about the current symptoms. The three scales are: lack of inattentiveness, hyperactivity and impulsiveness.
Measured: Screening to end of treatment at week 16
ADHS-DC-Q total score (range 0-66) change to BL/V0 (V1)
The ADHS-DC-Q consists of 18 items with a four-level response (not existing, slightly existing, moderately existing, strongly existing). The items ask about the current symptoms. The three scales are: lack of inattentiveness, hyperactivity and impulsiveness.
Measured: from baseline to end of titration at week 4 (V1)
QIDS-SR-16 total score (range 0-27) for all available visits (V0 to V5)
QIDS-SR-16 is a self-report measure of depression consisting of 16 items. Questions in the QIDS - SR-16 correlate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia), Sad mood, Decrease/increase in appetite/weight , Concentration , Self-criticism, Suicidal ideation, Interest, Energy/fatigue, Psychomotor agitation/retardation. Scoring is given from 0 to 3 whereas 0 indicates less impact, 3 highest impact in depression.
Measured: baseline to end of treatment at 16 weeks
QIDS-SR-16 total score (range 0-27) change to BL/V0 (V5)
QIDS-SR-16 is a self-report measure of depression consisting of 16 items. Questions in the QIDS - SR-16 correlate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia), Sad mood, Decrease/increase in appetite/weight , Concentration , Self-criticism, Suicidal ideation, Interest, Energy/fatigue, Psychomotor agitation/retardation. Scoring is given from 0 to 3 whereas 0 indicates less impact, 3 highest impact in depression.
Measured: from baseline to end of treatment at week 16 (V5)
Mean dose intake from V1 to V5 per treatment group
Mean dose intake from V1 to V5 per treatment group
Measured: 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
Mean dose intake compared to planned dose after titration phase per treatment group
Measured: 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
Proportion of patients with less than 80% of planned dose intake per treatment group
Measured: visit 1 (4 weeks after baseline) until end of treatment at week 16
Number of patients by dosage group at V1 and V2
Number of patients by dosage group (DEX IR: 10 mg, 15 mg, 20 mg, 30 mg; DEX XL: 10 mg, 15 mg, 20 mg, 30 mg; Placebo: 10 mg, 15 mg, 20 mg, 30 mg))
Measured: 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
Proportion of patients by dosage group (DEX IR: 10 mg, 15 mg, 20 mg, 30 mg; DEX XL: 10 mg, 15 mg, 20 mg, 30 mg; Placebo: 10 mg, 15 mg, 20 mg, 30 mg))
Measured: 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)
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)
Measured: 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)
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)
Measured: end of titration phase (visit 1) 4 weeks after baseline until end of treatment at week 16 (12 weeks after titration phase)
Number of patients with early withdrawal from therapy due to adverse events
Number of patients with early withdrawal from therapy due to adverse events in total
Measured: baseline until end of treatment at week 16 (12 weeks after end of titration phase)
Number of patients with early withdrawal from therapy due to adverse events per treatment group
Number of patients with early withdrawal from therapy due to adverse events per treatment group
Measured: 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 in total
Percentage of patients with early withdrawal from therapy due to adverse events - in total
Measured: 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
Percentage of patients with early withdrawal from therapy due to adverse events per treatment group
Measured: 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
MADRS total score categorization by Müller et al.: 0-6 absence of symptoms; 7-19 mild depression, 20-34 moderate depression, 35-60 indicate a severe depression.
Measured: 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)
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: baseline until end of titration phase at week 4 (V1)
ADHS-DC-Q total score (range 0-66) change to BL/V0 (V1)
The ADHS-DC-Q consists of 18 items with a four-level response (not existing, slightly existing, moderately existing, strongly existing). The items ask about the current symptoms. The three scales are: lack of inattentiveness, hyperactivity and impulsiveness.
Measured: baseline until end of titration phase at week 4 (V1)
ADHS-DC-Q total score (range 0-66) change to BL/V0 (to V5)
The ADHS-DC-Q consists of 18 items with a four-level response (not existing, slightly existing, moderately existing, strongly existing). The items ask about the current symptoms. The three scales are: lack of inattentiveness, hyperactivity and impulsiveness.
Measured: baseline until end of treatment at week 16 (V5)
QIDS-SR-16 total score (range 0-27) change to BL/V0 (V1)
QIDS-SR-16 is a self-report measure of depression consisting of 16 items. Questions in the QIDS - SR-16 correlate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia), Sad mood, Decrease/increase in appetite/weight , Concentration , Self-criticism, Suicidal ideation, Interest, Energy/fatigue, Psychomotor agitation/retardation. Scoring is given from 0 to 3 whereas 0 indicates less impact, 3 highest impact in depression.
Measured: from baseline to end of titration (week 4, V1)
MADRS suicidal ideation score for all available visits
Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The questionnaire includes questions on ten symptoms related to depression. Each item yields a score of 0 to 6; the overall score thus ranges from 0 to 60. Higher MADRS score indicates more severe depression.
Measured: from enrollment to baseline (start of treatment, V0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start15 May 2025
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised, double blind
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Frank Behrens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Frank Behrens, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
- Investigators
- Andreas Reif, Prof. Dr. med., Study chair, Department of Psychiatry, Psychosomatics and Psychotherapy University Hospital Frankfurt am Main - Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967857
- Sponsor's protocol ID
- TMP-18122023-58
- Acronym
- DEXAD
- Status last verified
- Sep 2026
- First submitted
- 22 Apr 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No