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
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
|Study Type :||Observational|
|Estimated Enrollment :||36 participants|
|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|
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.
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 participants matched by age, gender and educational level without history of psychiatric disorders and no familial history of mood disorders will be recruited
- 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))
- 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)
- Attention [ Time Frame: Baseline and after 12 weeks ]Attention (Digits subtest forward -WAIS-IV- + Trail Making Test-A, TMT-A)
- Processing speed [ Time Frame: Baseline and after 12 weeks ]Psychomotor velocity (Digit Symbol Substitution Test, DSST)
- Verbal Memory [ Time Frame: Baseline and after 12 weeks ]
Memory cognitive domain explored with:
- Rey Auditory Verbal Learning Test (Verbal)
- 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
- Hot cognition [ Time Frame: Baseline and after 12 weeks ]
Emotion recognition ability explored with:
- Pictures of Facial Affect (POFA)
- Intelligence quotient [ Time Frame: Baseline ]Measure of pre-morbid intelligence (Vocabulary (WAIS IV) + Block Design (WAIS-IV))
- 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
- 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
- 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)
- 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)
- 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).
- 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.
- 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.
- 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.
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
|Contact: Narcís Cardoner, MD, PhD||0034 93 723 10 10 ext email@example.com|
|Contact: Maria Serra-Blasco, PhD||0034 93 723 10 10 ext firstname.lastname@example.org|
|Corporació Sanitària Parc Taulí||Recruiting|
|Sabadell, Spain, 08208|
|Contact: Narcís Cardoner, PhD +0034937240182 ext +0034937240182 email@example.com|
|Contact: Maria Serra-Blasco, PhD +0034937240182 ext +0034937240182 firstname.lastname@example.org|