Switching From SSRI to Desvenlafaxine on Cognitive Functioning
NCT ID: NCT03432221
Last Updated: 2019-04-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
36 participants
Study Classification
OBSERVATIONAL
Study Start Date
2018-04-03
Study Completion Date
2019-06-03
Brief Summary
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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.
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.
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Detailed Description
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BACKGROUND
Depression is a significant contributor to the global burden of disease and affects people in all communities across the world. Today, depression is estimated to affect 350 million people. The World Mental Health Survey conducted in 17 countries found that, on average, about 1 in 20 people reported having an episode of depression in the previous year. Depressive disorders often start at a young age; drastically reduce people's functioning and often are recurring. For all these reasons, depression is the leading cause of disability worldwide in terms of total years lost due to disability.
Commonly the diagnosis and treatment of major depressive disorder is based on mood symptoms. However, cognitive impairments are often present in this disorder. In this respect, the recent Diagnostic and Statistical Manual 5 (DSM-5) highlight impairment in cognitive function as a criterion in the diagnosis of a major depressive episode (MDE) (American Psychiatric Association. At clinical level, patients frequently present subjective complaints during and after resolution of an MDE. Moreover, objective deficits measured by neuropsychological tests are also reported in different cognitive domains in cold cognitive function - executive function, processing speed, attention, learning or memory- (Hammar \&Ardal, 2009) or also in hot cognitive function -negative biases in perception, attention and memory, and aberrant reward/punishment processing-.
Different meta-analyses have demonstrated that these deficits may emerge from the first depressive episode with relevant intensification during each acute MDE persisting in some depressive patients even during the resolution of the acute episode. These deficits, both in an acute episode and in remission, have a relevant impact on clinical and functional outcomes, in the first case by reducing the chance to fully recover and in the second by increasing the risk of relapse. Moreover, cognitive deficits have shown to have a negative influence in functional performance in academic, social and working life (Lee et al., 2013,). In this context, recent studies have shown that a larger number of MDD episodes, a longer duration of illness and a poor response to antidepressant treatments might explain the maintenance of cognitive dysfunction, even in patients with some clinical response.
Persistent cognitive deficits in depression play a crucial role in some patients׳ ability to achieve a functional recovery. With this respect, cognitive function in depression is significantly also related to employment status. A preliminary study suggests that deficits in executive functioning have a mediating effect on the relationship between depression and impaired activities of daily living. Moreover, mood disorder patients with neuropsychological deficits tend to be less compliant with antidepressant treatment (Martinez-Aran et al., 2009) and show an increased risk for suicide. In this context, the identification and treatment of specific cognitive deficits may be a cardinal aspect in the achievement of depression recovery and, even more important, in the functional normalization of patients to their pre-morbid levels.
At present there is a growing interest on the role of antidepressant treatment in the modulation of cognitive deficits associated with depression. Despite the wide array of effective antidepressant agents, the knowledge on the impact of available drugs on cognitive function constitutes a relevant unmet need. Indeed, the number of studies focusing on this issue is relatively scarce and the outcome of cognitive symptoms is widely variable. Potential pro-cognitive effect of a particular antidepressant mostly relay on its specific mechanisms of action, anf in the last years the evidence accumulated have support that drug involving more targets such as dual (duloxetine) or multimodal (vortioxetine) antidepressants show more pro-cognitive properties than those with one major mechanism (SSRI).
However, the clinical studies putting cognitive dysfunction as the primary outcome in depression trials are scarce and further support of these initial promising findings of the effects of dual/multimodal antidepressants on cognition are required.
OBJECTIVES
This open-label clinical study will evaluate the clinical outcome of switching to desvenlafaxine on cognitive function of patients with major depressive disorder with inadequate response to selective serotonin reuptake inhibitor (SSRI)
\* Primary Objective
To study differences in cognitive function in moderate to severe MDD patients with inadequate response to SSRI and healthy controls at baseline and after 12 weeks of treatment with desvenlafaxine.
\* Secondary Objective
To study differences in subjective cognitive function (cognitive complains), measured by PDQ-5 at baseline and after 12 weeks of treatment with Desvenlafaxine.
To study differences in cognitive function, measured by neuropsychological tests battery (including cold and hot cognitive function) at baseline and after 12 weeks of treatment with desvenlafaxine.
To study differences in depression severity, measured HDRS-17 and CGI at baseline and after 12 weeks of treatment with desvenlafaxine.
To study changes in subjective remission and functional status measured with Remission Depression Questionnaire (RDQ) and the Short Assessement Functioning Test (FAST), respectively.
Depression is a significant contributor to the global burden of disease and affects people in all communities across the world. Today, depression is estimated to affect 350 million people. The World Mental Health Survey conducted in 17 countries found that, on average, about 1 in 20 people reported having an episode of depression in the previous year. Depressive disorders often start at a young age; drastically reduce people's functioning and often are recurring. For all these reasons, depression is the leading cause of disability worldwide in terms of total years lost due to disability.
Commonly the diagnosis and treatment of major depressive disorder is based on mood symptoms. However, cognitive impairments are often present in this disorder. In this respect, the recent Diagnostic and Statistical Manual 5 (DSM-5) highlight impairment in cognitive function as a criterion in the diagnosis of a major depressive episode (MDE) (American Psychiatric Association. At clinical level, patients frequently present subjective complaints during and after resolution of an MDE. Moreover, objective deficits measured by neuropsychological tests are also reported in different cognitive domains in cold cognitive function - executive function, processing speed, attention, learning or memory- (Hammar \&Ardal, 2009) or also in hot cognitive function -negative biases in perception, attention and memory, and aberrant reward/punishment processing-.
Different meta-analyses have demonstrated that these deficits may emerge from the first depressive episode with relevant intensification during each acute MDE persisting in some depressive patients even during the resolution of the acute episode. These deficits, both in an acute episode and in remission, have a relevant impact on clinical and functional outcomes, in the first case by reducing the chance to fully recover and in the second by increasing the risk of relapse. Moreover, cognitive deficits have shown to have a negative influence in functional performance in academic, social and working life (Lee et al., 2013,). In this context, recent studies have shown that a larger number of MDD episodes, a longer duration of illness and a poor response to antidepressant treatments might explain the maintenance of cognitive dysfunction, even in patients with some clinical response.
Persistent cognitive deficits in depression play a crucial role in some patients׳ ability to achieve a functional recovery. With this respect, cognitive function in depression is significantly also related to employment status. A preliminary study suggests that deficits in executive functioning have a mediating effect on the relationship between depression and impaired activities of daily living. Moreover, mood disorder patients with neuropsychological deficits tend to be less compliant with antidepressant treatment (Martinez-Aran et al., 2009) and show an increased risk for suicide. In this context, the identification and treatment of specific cognitive deficits may be a cardinal aspect in the achievement of depression recovery and, even more important, in the functional normalization of patients to their pre-morbid levels.
At present there is a growing interest on the role of antidepressant treatment in the modulation of cognitive deficits associated with depression. Despite the wide array of effective antidepressant agents, the knowledge on the impact of available drugs on cognitive function constitutes a relevant unmet need. Indeed, the number of studies focusing on this issue is relatively scarce and the outcome of cognitive symptoms is widely variable. Potential pro-cognitive effect of a particular antidepressant mostly relay on its specific mechanisms of action, anf in the last years the evidence accumulated have support that drug involving more targets such as dual (duloxetine) or multimodal (vortioxetine) antidepressants show more pro-cognitive properties than those with one major mechanism (SSRI).
However, the clinical studies putting cognitive dysfunction as the primary outcome in depression trials are scarce and further support of these initial promising findings of the effects of dual/multimodal antidepressants on cognition are required.
OBJECTIVES
This open-label clinical study will evaluate the clinical outcome of switching to desvenlafaxine on cognitive function of patients with major depressive disorder with inadequate response to selective serotonin reuptake inhibitor (SSRI)
\* Primary Objective
To study differences in cognitive function in moderate to severe MDD patients with inadequate response to SSRI and healthy controls at baseline and after 12 weeks of treatment with desvenlafaxine.
\* Secondary Objective
To study differences in subjective cognitive function (cognitive complains), measured by PDQ-5 at baseline and after 12 weeks of treatment with Desvenlafaxine.
To study differences in cognitive function, measured by neuropsychological tests battery (including cold and hot cognitive function) at baseline and after 12 weeks of treatment with desvenlafaxine.
To study differences in depression severity, measured HDRS-17 and CGI at baseline and after 12 weeks of treatment with desvenlafaxine.
To study changes in subjective remission and functional status measured with Remission Depression Questionnaire (RDQ) and the Short Assessement Functioning Test (FAST), respectively.
Conditions
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Major Depressive Disorder
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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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.
Desvenlafaxine
Intervention Type
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.
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
No interventions assigned to this group
Interventions
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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.
Intervention Type
DRUG
Eligibility Criteria
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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).
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.
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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Pfizer
INDUSTRY
Sponsor Role
collaborator
Corporacion Parc Tauli
OTHER
Sponsor Role
lead
Responsible Party
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Narcis Cardoner, MD, PhD
Narcís Cardoner, MD, PhD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Corporació Sanitària Parc Taulí
Sabadell, , Spain
Site Status
RECRUITING
Countries
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Spain
Central Contacts
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Facility Contacts
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References
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Baune BT, Miller R, McAfoose J, Johnson M, Quirk F, Mitchell D. The role of cognitive impairment in general functioning in major depression. Psychiatry Res. 2010 Apr 30;176(2-3):183-9. doi: 10.1016/j.psychres.2008.12.001.
Reference Type
BACKGROUND
Bora E, Harrison BJ, Yucel M, Pantelis C. Cognitive impairment in euthymic major depressive disorder: a meta-analysis. Psychol Med. 2013 Oct;43(10):2017-26. doi: 10.1017/S0033291712002085. Epub 2012 Oct 26.
Reference Type
BACKGROUND
Ferguson JM, Wesnes KA, Schwartz GE. Reboxetine versus paroxetine versus placebo: effects on cognitive functioning in depressed patients. Int Clin Psychopharmacol. 2003 Jan;18(1):9-14. doi: 10.1097/00004850-200301000-00002.
Reference Type
BACKGROUND
Hammar A, Ardal G. Cognitive functioning in major depression--a summary. Front Hum Neurosci. 2009 Sep 25;3:26. doi: 10.3389/neuro.09.026.2009. eCollection 2009.
Reference Type
BACKGROUND
Herrera-Guzman I, Gudayol-Ferre E, Herrera-Abarca JE, Herrera-Guzman D, Montelongo-Pedraza P, Padros Blazquez F, Pero-Cebollero M, Guardia-Olmos J. Major Depressive Disorder in recovery and neuropsychological functioning: effects of selective serotonin reuptake inhibitor and dual inhibitor depression treatments on residual cognitive deficits in patients with Major Depressive Disorder in recovery. J Affect Disord. 2010 Jun;123(1-3):341-50. doi: 10.1016/j.jad.2009.10.009. Epub 2009 Nov 6.
Reference Type
BACKGROUND
Herrera-Guzman I, Gudayol-Ferre E, Herrera-Guzman D, Guardia-Olmos J, Hinojosa-Calvo E, Herrera-Abarca JE. Effects of selective serotonin reuptake and dual serotonergic-noradrenergic reuptake treatments on memory and mental processing speed in patients with major depressive disorder. J Psychiatr Res. 2009 Jun;43(9):855-63. doi: 10.1016/j.jpsychires.2008.10.015. Epub 2009 Jan 6.
Reference Type
BACKGROUND
Jaeger J, Berns S, Uzelac S, Davis-Conway S. Neurocognitive deficits and disability in major depressive disorder. Psychiatry Res. 2006 Nov 29;145(1):39-48. doi: 10.1016/j.psychres.2005.11.011. Epub 2006 Oct 11.
Reference Type
BACKGROUND
Kiosses DN, Alexopoulos GS. IADL functions, cognitive deficits, and severity of depression: a preliminary study. Am J Geriatr Psychiatry. 2005 Mar;13(3):244-9. doi: 10.1176/appi.ajgp.13.3.244.
Reference Type
BACKGROUND
Lee RS, Hermens DF, Porter MA, Redoblado-Hodge MA. A meta-analysis of cognitive deficits in first-episode Major Depressive Disorder. J Affect Disord. 2012 Oct;140(2):113-24. doi: 10.1016/j.jad.2011.10.023. Epub 2011 Nov 15.
Reference Type
BACKGROUND
Levkovitz Y, Caftori R, Avital A, Richter-Levin G. The SSRIs drug Fluoxetine, but not the noradrenergic tricyclic drug Desipramine, improves memory performance during acute major depression. Brain Res Bull. 2002 Aug 15;58(4):345-50. doi: 10.1016/s0361-9230(01)00780-8.
Reference Type
BACKGROUND
Martinez-Aran A, Scott J, Colom F, Torrent C, Tabares-Seisdedos R, Daban C, Leboyer M, Henry C, Goodwin GM, Gonzalez-Pinto A, Cruz N, Sanchez-Moreno J, Vieta E. Treatment nonadherence and neurocognitive impairment in bipolar disorder. J Clin Psychiatry. 2009 Jul;70(7):1017-23. doi: 10.4088/JCP.08m04408. Epub 2009 Jun 2.
Reference Type
BACKGROUND
McIntyre RS, Lophaven S, Olsen CK. A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults. Int J Neuropsychopharmacol. 2014 Oct;17(10):1557-67. doi: 10.1017/S1461145714000546. Epub 2014 Apr 30.
Reference Type
BACKGROUND
Miskowiak KW, Carvalho AF. 'Hot' cognition in major depressive disorder: a systematic review. CNS Neurol Disord Drug Targets. 2014;13(10):1787-803. doi: 10.2174/1871527313666141130205713.
Reference Type
BACKGROUND
Nierenberg AA, Husain MM, Trivedi MH, Fava M, Warden D, Wisniewski SR, Miyahara S, Rush AJ. Residual symptoms after remission of major depressive disorder with citalopram and risk of relapse: a STAR*D report. Psychol Med. 2010 Jan;40(1):41-50. doi: 10.1017/S0033291709006011. Epub 2009 May 22.
Reference Type
BACKGROUND
Roiser JP, Sahakian BJ. Hot and cold cognition in depression. CNS Spectr. 2013 Jun;18(3):139-49. doi: 10.1017/S1092852913000072. Epub 2013 Mar 12.
Reference Type
BACKGROUND
Trivedi MH, Greer TL. Cognitive dysfunction in unipolar depression: implications for treatment. J Affect Disord. 2014 Jan;152-154:19-27. doi: 10.1016/j.jad.2013.09.012. Epub 2013 Sep 25.
Reference Type
BACKGROUND
Wagner S, Doering B, Helmreich I, Lieb K, Tadic A. A meta-analysis of executive dysfunctions in unipolar major depressive disorder without psychotic symptoms and their changes during antidepressant treatment. Acta Psychiatr Scand. 2012 Apr;125(4):281-92. doi: 10.1111/j.1600-0447.2011.01762.x. Epub 2011 Oct 18.
Reference Type
BACKGROUND
Westheide J, Quednow BB, Kuhn KU, Hoppe C, Cooper-Mahkorn D, Hawellek B, Eichler P, Maier W, Wagner M. Executive performance of depressed suicide attempters: the role of suicidal ideation. Eur Arch Psychiatry Clin Neurosci. 2008 Oct;258(7):414-21. doi: 10.1007/s00406-008-0811-1. Epub 2008 Mar 11.
Reference Type
BACKGROUND
Vicent-Gil M, Trujols J, Sagues T, Serra-Blasco M, Navarra-Ventura G, Mantellini CL, Crivilles S, Portella MJ, Cardoner N. Insights on the cognitive enhancement effect of desvenlafaxine in major depressive disorder. Ann Gen Psychiatry. 2025 Mar 19;24(1):16. doi: 10.1186/s12991-025-00552-2.
Reference Type
DERIVED
Other Identifiers
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2017.116
Identifier Type: -
Identifier Source: org_study_id
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