Switching From SSRI to Desvenlafaxine on Cognitive Functioning

NCT03432221 | Unknown FDA Drug

• 1 other identifier: 2017.116
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Cognition, antidepressants drugs, SNRI, hot cognition, functioning

Outcome Measures

Primary Outcomes (1)

• Composite cognitive measure

  Composite z-score (Digit Symbol Substitution Test (DSST) + Rey Auditory Verbal Learning Test (RAVLT))

  Change from baseline to 12 weeks

Secondary Outcomes (15)

• Subjective cognitive function

  Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week

• Attention

  Baseline and after 12 weeks

• Processing speed

  Baseline and after 12 weeks

• Verbal Memory

  Baseline and after 12 weeks

• Executive Functions

  Baseline and after 12 weeks

Study Arms (2)

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

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

Interventions

Desvenlafaxine DRUG

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.

MDD

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

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

You may not qualify if:

• 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.
• Subjects with any present or past disease involving the nervous central system
• A clinically significant unstable illness or clinically significant abnormal vital signs as determined by the investigator
• Women entering the study could not be pregnant, and had to be oral contraceptive-free.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Pfizer: collaborator

Study Sites (1)

Corporació Sanitària Parc Taulí

Sabadell, 08208, Spain

RECRUITING

Related Publications (19)

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  PMID: 40108685 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Central Study Contacts

Narcís Cardoner, MD, PhD

CONTACT

0034 93 723 10 10; ncardoner@tauli.cat

Maria Serra-Blasco, PhD

CONTACT

0034 93 723 10 10; mserrab@tauli.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Narcís Cardoner, MD, PhD

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: February 14, 2018
• Study Start: April 3, 2018
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

ES (1)