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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEX IR | Experimental | tablets twice daily |
|
| DEX XL | Experimental | capsule once daily |
|
| PLC | Placebo Comparator | tablet or capsule as comparator to verum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEX IR tablets | Drug | tablet twice daily |
| |
| DEX XL |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AE) until V5 | Dokumentation of AE | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christin Jonetzko | Contact | +49 69 630180210 | christin.jonetzko@itmp.fraunhofer.de | |
| Anja Kuehne | Contact | anja.kuehne@itmp.fraunhofer.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Reif, Prof. Dr. med. | Department of Psychiatry, Psychosomatics and Psychotherapy University Hospital Frankfurt am Main - Goethe University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Psychosomatics and Psychotherapy University Hospital Frankfurt am Main - Goethe University | Recruiting | Frankfurt | 60590 | Germany |
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randomised, double blind
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| Drug |
capsule once daily |
|
| Placebo | Drug | Placebo to either capsule or tablet |
|
| 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 | from baseline until end of study at week 17 |
| Number of AE until V5 | Number of AE | through study treatment (up to 16 weeks) |
| Number of AE until V5 and until end of study | Number of AE | from baseline until end of study at week 17 |
| Number of AE/SAE during the study period | Number of AE/SAE | through study treatment (up to 16 weeks) |
| number of patients with AE/SAE by type during study period | Number and type of AE/SAE | 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 | 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) | 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) | 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 | 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 | 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" | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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)) | 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)) | 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) | 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) | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | from enrollment to baseline (start of treatment, V0) |
| University Leipzig, Department of Psychiatry and Psychotherapy | Recruiting | Leipzig | 04103 | Germany |
|
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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