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DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Major Depression Episode (MDE) Follow-up (Major Depression Episode (MDE) Follow-up)

- 09-04-20 - 1 Formulier, 3 Itemgroepen, 23 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Major Depression Episode (MDE), Major Depression Episode (MDE) since last visit
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Major Depression Episode (MDE) Follow-up form. It has to be filled in for follow-up visits. For use of this questionnaire no licence is required.

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Major Depression Episode (MDE) Baseline (Major Depression Episode (MDE) Baseline)

- 09-04-20 - 1 Formulier, 4 Itemgroepen, 26 Data-elementen, 1 Taal
Itemgroepen: Administrative Data, Major Depression Episode (MDE), Major Depression Episode (MDE) lifetime, MDE - Lifetime
DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the Major Depression Episode (MDE) Baseline form. It has to be filled in for Baseline. For use of this questionnaire no licence is required.

Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder 101497 - End of Study Record

- 21-02-18 - 1 Formulier, 4 Itemgroepen, 9 Data-elementen, 1 Taal
Itemgroepen: study conclusion, status of treatment blind, investigational product discontinuation, Comments
A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

Eligibility Major Depressive Disorder NCT01423240

- 20-09-21 - 1 Formulier, 2 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
Major Depressive Disorder With Mixed Features; ODM derived from: https://clinicaltrials.gov/show/NCT01423240

Eligibility Major Depressive Disorder NCT02311725

- 20-09-21 - 1 Formulier, 1 Itemgroep, 11 Data-elementen, 1 Taal
Itemgroep: Inclusion Criteria
Storytelling Video Intervention for Depressed Primary Care Patients - Pilot Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02311725 Principal Investigator: Lisa Uebelacker, PhD Butler Hospital/Brown University and Brandon Gaudiano, PhD Butler Hospital/Brown University

Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder - 101497 - Additional Forms

- 22-02-18 - 1 Formulier, 7 Itemgroepen, 31 Data-elementen, 1 Taal
Itemgroepen: home pregnancy test result, prior and concomitant medications, adverse events, repeat 12-lead electrocardiogram, repeat laboratory tests, investigational product, Comments
A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder 101497 - Early Withdrawal

- 21-02-18 - 1 Formulier, 10 Itemgroepen, 26 Data-elementen, 2 Talen
Itemgroepen: Patient related scales, Subject satisfaction with study medication, Vital Signs, Adverse Events, Concomitant Medication Prompt, 12-lead Electrocardiogram, Laboratory tests, Serum hCG, Investigational Product, Comments
A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder 101497 - Visit 10 (Additional Safety Follow-Up)

- 21-02-18 - 1 Formulier, 8 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Vital Signs, Adverse Events, Concomitant Medication Prompt, Repeat 12-lead electrocardiogram prompt, Repeat Laboratory tests, Investigational Product, Urine dipstick pregnancy test, Comments
A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder 101497 - Visit 9 (Mandatory Safety Follow-Up)

- 21-02-18 - 1 Formulier, 8 Itemgroepen, 12 Data-elementen, 1 Taal
Itemgroepen: Vital Signs, Adverse Events, Concomitant Medication Prompt, Repeat 12-lead electrocardiogram prompt, Repeat Laboratory tests, Investigational Product, Urine dipstick pregnancy test, Comments
A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder [ID 101497] - Visit 8 (End of Taper Phase Visit)

- 21-02-18 - 1 Formulier, 7 Itemgroepen, 9 Data-elementen, 1 Taal
Itemgroepen: Vital Signs, Adverse Events, Concomitant Medication Prompt, Repeat 12-lead electrocardiogram prompt, Repeat Laboratory tests, Investigational Product, Comments
A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder 101497 - Visit 7 (End of Week 8)

- 21-02-18 - 1 Formulier, 10 Itemgroepen, 26 Data-elementen, 2 Talen
Itemgroepen: Patient related scales, Subject satisfaction with study medication, Vital Signs, Adverse Events, Concomitant Medication Prompt, 12-lead Electrocardiogram, Laboratory tests, Serum hCG, Investigational Product, Comments
A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

Study Evaluating Extended-Release Bupropion Hydrochloride and Extended-Release Venlafaxine Hydrochloride in Subjects with Major Depressive Disorder ID 101497 - Visit 5A (End of Week 5)

- 21-02-18 - 1 Formulier, 6 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Patient related scales, Vital Signs, Adverse Events, Concomitant Medication Prompt, Investigational Product, Comments
A Multi-Centre, Randomised, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Flexible Dose Study Evaluating the Efficacy, Safety and Tolerability of Extended-Release Bupropion Hydrochloride (150mg - 300mg once daily), Extended-Release Venlafaxine Hydrochloride (75mg - 150mg once daily) and Placebo in Subjects with Major Depressive Disorder

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