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Trial record 2 of 7 for:    Recruiting, Not yet recruiting, Available Studies | "O-desmethylvenlafaxine"

Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression (VIVRE)

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ClinicalTrials.gov Identifier: NCT04448431
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benefit

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Vortioxetine Drug: Desvenlafaxine Phase 4

Detailed Description:

The study will consist of a screening period of up to 14 days before the Baseline Visit, followed by an 8-week Treatment Period with vortioxetine or desvenlafaxine. A Safety Follow-up Visit will be performed approximately 4 weeks after the Primary Outcome/Withdrawal Visit.

At Baseline, patients will be equally randomised (1:1) to 1 of the 2 treatment groups for an 8-week, double-blind Treatment Period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel-group, Active Controlled Study Evaluating the Efficacy of Vortioxetine Versus Desvenlafaxine in Adult Patients Suffering From Major Depressive Disorder With Partial Response to SSRI Treatment
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vortioxetine
8 weeks treatment
Drug: Vortioxetine
10 or 20 mg/day, capsules, orally

Active Comparator: Desvenlafaxine
8 weeks treatment
Drug: Desvenlafaxine
50 mg/day capsules, orally




Primary Outcome Measures :
  1. Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score [ Time Frame: From baseline to Week 8 ]
    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.


Secondary Outcome Measures :
  1. Remission (defined as a MADRS total score =<10) [ Time Frame: At Week 8 ]
    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.

  2. Response (defined as a => 50% decrease from baseline in MADRS total score) [ Time Frame: At Week 8 ]
    The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.

  3. Change in MADRS anhedonia factor score [ Time Frame: From baseline to Week 8 ]
    (based on items 1(apparent sadness),2 (reported sadness),6 (concentration difficulties),7 (lassitude),8 (inability to feel))

  4. Change in Digital Symbol Substitution Test (DSST) total score [ Time Frame: From baseline to Week 8 ]
    DSST assesses psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-s period. Each correct symbol is counted, and the total score ranges from 0 (< normal functioning) to 133 (> normal functioning).

  5. The proportion number of Hard Choice/number of High Reward trials and number of Low choice/number of Low Reward trials when performing the Effort- Expenditure for Rewards Task (EEfRT) [ Time Frame: From baseline to Week 8 ]
    The EEfRT is a computerized task which measures reward motivation in which participants are presented with a series of repeated trials during which they choose between performing a ''hard-task'' or an ''easy-task'' in order to earn varying amounts of monetary rewards.

  6. Change in Clinical Global Impression - Severity of Illness (CGI-S) score [ Time Frame: from baseline to Week 8 ]
    The CGI-S scale measures the severity of psychiatric symptoms on a 7-point scale from 1-7. The scores indicated the following: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. The score ranged from 1-7, where 1 indicated absence of symptoms and higher score indicated greater severity of symptoms.

  7. Clinical Global Impression Scale- Global Improvement (CGI-I) score [ Time Frame: at Day 7,28,56 ]
    The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse)

  8. Change in Functioning Assessment Short Test (FAST) total score [ Time Frame: From baseline to Week 8 ]
    The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time

  9. Change in FAST sub-domain scores [ Time Frame: From baseline to Week 8 ]
    The FAST is a clinician-rated scale designed to assess difficulty in functioning. The FAST consists of 24 items in 6 specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, leisure time. Each item is rated on a 4-point scale from 0 (no difficulty) to 3 (severe difficulty). The items are summed to yield a total score ranging from 0 to 72 with higher scores reflecting more serious difficulties.

  10. Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score [ Time Frame: From baseline to Week 8 ]
    The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)

  11. Change in Q-LES-Q work subscale [ Time Frame: From baseline to Week 8 ]
    The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)

  12. Change in Q-LES-Q household duties subscale [ Time Frame: From baseline to Week 8 ]
    The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)

  13. Change in Q-LES-Q school/course subscale [ Time Frame: From baseline to Week 8 ]
    The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)

  14. Change in Q-LES-Q leisure time activities subscale [ Time Frame: From baseline to Week 8 ]
    The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)

  15. Change in Q-LES-Q social relations subscale [ Time Frame: From baseline to Week 8 ]
    The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has a primary diagnosis of single or recurrent MDD, diagnosed according to DSM-5®. The current MDE must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
  • The patient has a MADRS total score ≥24 at screening and baseline.
  • The patient has had the current MDE for ≥3 months and < 12 months.
  • The patient has been treated with an SSRI as monotherapy (citalopram, escitalopram, paroxetine, sertraline) for at least 6 weeks at licensed dose for the current MDE with a partial response and is a candidate for a switch in the investigator's opinion.
  • The patient wants to switch antidepressant treatment.

Exclusion Criteria:

  • The patient has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.

Other in- and exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448431


Contacts
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Contact: Email contact via H. Lundbeck A/S +45 36301311 LundbeckClinicalTrials@Lundbeck.com

Locations
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Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT04448431    
Other Study ID Numbers: 18498A
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Desvenlafaxine Succinate
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vortioxetine
Antidepressive Agents
Psychotropic Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin and Noradrenaline Reuptake Inhibitors