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Switching From SSRI to Desvenlafaxine on Cognitive Functioning

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ClinicalTrials.gov Identifier: NCT03432221
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Narcis Cardoner, MD, PhD, Corporacion Parc Tauli

Brief Summary:

Given the importance of cognitive function on depressed patients' treatment outcome and return to premorbid functioning, the effect of antidepressant drugs on cognition has become of primary concern. The aim of the present study is to assess the clinical outcome of switching from a selective serotonin reuptake inhibitor (SSRI) to desvenlafaxine on cognitive function in a Spanish sample of adults with moderate to severe major depressive disorder (MDD).

This open-label clinical study will include a total of 36 MDD outpatients receiving treatment with desvenlafaxine according to treating psychiatrist clinical judgment.

The primary efficacy endpoint will be changes from baseline to week 12 in cognitive function measured by a composite z-score comprising the Digit Symbol Substitution Test (DSST) and Rey Auditory Verbal Learning Test (RAVLT) scores. The secondary efficacy endpoints will involve depression severity, additional measures of subjective and objective cognitive function (including cold and hot cognitive function tasks), and functional status.

A matched sample of 36 healthy controls will be assessed in order to obtain reference data for all cognitive function measurements. Patients with MDD and healthy controls will be compared regarding cognitive function both at baseline and after 12 weeks.


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

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Efficacy Of Switching From SSRI to Desvenlafaxine on Cognitive Function In Patients With an Acute Episode of Major Depression
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : June 3, 2019
Estimated Study Completion Date : June 3, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MDD
Patients who met DSM-5 criteria for MDD attending the outpatient psychiatric service of the Hospital Universitari Parc Taulí. Patients must have a lack of response to SSRI (Maximize dose for adequate time), being the next therapeutic option the introduction of desvenlafaxine.
Drug: Desvenlafaxine
Patients included in the study will receive antidepressant treatment with desvenlafaxine. The switch from SSRI to desvenlafaxine will coincide with the baseline visit (Visit 0). The dose of desvenlafaxine will be established based on clinical judgment. As the approach will be naturalistic, the inclusion in this study will not influence the clinical choice, hence changes in the pharmacological strategy will be permitted.

Healthy Controls
Healthy participants matched by age, gender and educational level without history of psychiatric disorders and no familial history of mood disorders will be recruited



Primary Outcome Measures :
  1. Composite cognitive measure [ Time Frame: Change from baseline to 12 weeks ]
    Composite z-score (Digit Symbol Substitution Test (DSST) + Rey Auditory Verbal Learning Test (RAVLT))


Secondary Outcome Measures :
  1. Subjective cognitive function [ Time Frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week ]
    Perceived deficit Questionnaire short version (PDQ-5)

  2. Attention [ Time Frame: Baseline and after 12 weeks ]
    Attention (Digits subtest forward -WAIS-IV- + Trail Making Test-A, TMT-A)

  3. Processing speed [ Time Frame: Baseline and after 12 weeks ]
    Psychomotor velocity (Digit Symbol Substitution Test, DSST)

  4. Verbal Memory [ Time Frame: Baseline and after 12 weeks ]

    Memory cognitive domain explored with:

    - Rey Auditory Verbal Learning Test (Verbal)


  5. Executive Functions [ Time Frame: Baseline and after 12 weeks ]
    Composite score composed by: Trail Making Test-B + Phonetic fluency & semantic fluency + Wisconsin Card Sorting Test

  6. Hot cognition [ Time Frame: Baseline and after 12 weeks ]

    Emotion recognition ability explored with:

    - Pictures of Facial Affect (POFA)


  7. Intelligence quotient [ Time Frame: Baseline ]
    Measure of pre-morbid intelligence (Vocabulary (WAIS IV) + Block Design (WAIS-IV))

  8. Depressive symptoms [ Time Frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week ]

    The Hamilton Depression Rating Scale, 17 items (HDRS), designed to rate the severity of depression in patients.

    0 - 7 = Normal 8 - 13 = Mild Depression 14-18 = Moderate Depression 19 - 22 = Severe Depression >23 = Very Severe Depression


  9. Anxiety symptoms [ Time Frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week ]

    The Hamilton Anxiety Rating Scale (HAM-A), to measure the severity of anxiety symptoms.

    14-17 = Mild Anxiety 18-24 = Moderate Anxiety 25-30 = Severe Anxiety


  10. Severity and improvement of depression [ Time Frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week ]
    The Clinical Global Impression (CGI)

  11. Self-perceived remission status [ Time Frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week ]
    The Remission from Depression Questionnaire (RDQ)

  12. Disability [ Time Frame: Baseline and after 12 weeks ]
    Functional disability measured with the Sheehan Disability Scale (SDS) SDS: developed to assess functional impairment in three inter-related domains; work/school, social and family life. The 3 items can also be summed into a single dimensional measure of global functional impairment that rages from 0 (unimpaired) to 30 (highly impaired).

  13. Functioning [ Time Frame: Baseline and after 12 weeks ]

    Functioning Assessment Short Test (FAST)

    FAST: brief instrument designed to assess the main functioning problems experienced by psychiatric patients, particularly those with mood disorders. Scores > 11(out of 75)= Impairment.


  14. Sexual dysfunction [ Time Frame: Baseline and after 12 weeks ]
    The Arizona Sexual Experience Scale (ASEX): a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm.

  15. Side effect rating scale for psychotropic drugs [ Time Frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week ]
    The UKU side effect rating scale: A Comprehensive Rating Scale for Psychotropic Drugs and a Cross-sectional Study of Side Effects in Neuroleptic-treated Patients.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients attending at the outpatient unit at the Psychiatry Department of the Hospital Universitari Parc Taulí will be consecutively recruited until the study sample (36) is reached.

Healthy controls will be seek from the same socio-demographic environment as patients (Vallès area, Spain)

Criteria

Inclusion Criteria:

  1. MDD Patients in whom switching to desvenlafaxine is considered by treating psychiatrist as the next treatment option.
  2. MDD diagnostic confirmation with the mini-international neuropsychiatric interview (MINI) (Sheehan et al., 1998),
  3. Age range between 18 and 60
  4. Non-response or incomplete response to a treatment with an SSRI in the current episode.
  5. Score of 18 points or higher in the Hamilton depression rating scale (HAM-D-17) (Hamilton, 1967).

Exclusion Criteria:

  1. Subjects will be excluded if they met criteria or had past history for the following disorders: posttraumatic stress disorder, obsessive-compulsive disorder, schizophrenia, psychotic, delusional, bipolar or substance abuse disorders. MINI will be used to exclude these potentially comorbid disorders.
  2. Subjects with any present or past disease involving the nervous central system
  3. A clinically significant unstable illness or clinically significant abnormal vital signs as determined by the investigator
  4. Women entering the study could not be pregnant, and had to be oral contraceptive-free.

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): NCT03432221


Contacts
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Contact: Narcís Cardoner, MD, PhD 0034 93 723 10 10 ext 22205 ncardoner@tauli.cat
Contact: Maria Serra-Blasco, PhD 0034 93 723 10 10 ext 22205 mserrab@tauli.cat

Locations
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Spain
Corporació Sanitària Parc Taulí Recruiting
Sabadell, Spain, 08208
Contact: Narcís Cardoner, PhD    +0034937240182 ext +0034937240182    ncardoner@tauli.cat   
Contact: Maria Serra-Blasco, PhD    +0034937240182 ext +0034937240182    mserrab@tauli.cat   
Sponsors and Collaborators
Corporacion Parc Tauli
Pfizer

Publications:

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Responsible Party: Narcis Cardoner, MD, PhD, Narcís Cardoner, MD, PhD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT03432221     History of Changes
Other Study ID Numbers: 2017.116
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Narcis Cardoner, MD, PhD, Corporacion Parc Tauli:
Cognition, antidepressants drugs, SNRI, hot cognition, functioning
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Desvenlafaxine Succinate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs