Major Depressive DisorderNCT03432221
Switching From SSRI to Desvenlafaxine on Cognitive Functioning
An observational study of Major Depressive Disorder, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Desvenlafaxine
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 3 Apr 2018to 3 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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)
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Corporació Sanitària Parc Taulí
Sabadell, 08208
Narcís Cardoner, PhD, +0034937240182 ext. +0034937240182, ncardoner@tauli.cat
Maria Serra-Blasco, PhD, +0034937240182 ext. +0034937240182, mserrab@tauli.cat
About this study
Official title: Efficacy Of Switching From SSRI to Desvenlafaxine on Cognitive Function In Patients With an Acute Episode of Major Depression
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Desvenlafaxine
- Keywords
- Cognition, antidepressants drugs, SNRI, hot cognition, functioning
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesvenlafaxineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite cognitive measure
Composite z-score (Digit Symbol Substitution Test (DSST) + Rey Auditory Verbal Learning Test (RAVLT))
Measured: Change from baseline to 12 weeks
Secondary outcomes (15)
Subjective cognitive function
Perceived deficit Questionnaire short version (PDQ-5)
Measured: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week
Attention
Attention (Digits subtest forward -WAIS-IV- + Trail Making Test-A, TMT-A)
Measured: Baseline and after 12 weeks
Processing speed
Psychomotor velocity (Digit Symbol Substitution Test, DSST)
Measured: Baseline and after 12 weeks
Verbal Memory
Memory cognitive domain explored with:
- Rey Auditory Verbal Learning Test (Verbal)
Measured: Baseline and after 12 weeks
Executive Functions
Composite score composed by: Trail Making Test-B + Phonetic fluency \& semantic fluency + Wisconsin Card Sorting Test
Measured: Baseline and after 12 weeks
Hot cognition
Emotion recognition ability explored with:
- Pictures of Facial Affect (POFA)
Measured: Baseline and after 12 weeks
Intelligence quotient
Measure of pre-morbid intelligence (Vocabulary (WAIS IV) + Block Design (WAIS-IV))
Measured: Baseline
Depressive symptoms
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
Measured: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week
Anxiety symptoms
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
Measured: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week
Severity and improvement of depression
The Clinical Global Impression (CGI)
Measured: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week
Self-perceived remission status
The Remission from Depression Questionnaire (RDQ)
Measured: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week
Disability
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).
Measured: Baseline and after 12 weeks
Functioning
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.
Measured: Baseline and after 12 weeks
Sexual dysfunction
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.
Measured: Baseline and after 12 weeks
Side effect rating scale for psychotropic drugs
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.
Measured: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start3 Apr 2018
- Primary completion3 Jun 2019 (estimated)
- Study completion3 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Narcis Cardoner, MD, PhD, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432221
- Sponsor's protocol ID
- 2017.116
- Status last verified
- Apr 2019
- First submitted
- 8 Jan 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20138370Bora 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.
PubMed 23098294Ferguson 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.
PubMed 12490769Hammar 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.
PubMed 19826496Herrera-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.
PubMed 19896719Herrera-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.
PubMed 19128810Jaeger 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.
PubMed 17045658Kiosses 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.
PubMed 15728756Lee 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.
PubMed 22088608Levkovitz 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.
PubMed 12183009Martinez-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.
PubMed 19497247McIntyre 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.
PubMed 24787143Miskowiak 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.
PubMed 25470389Nierenberg 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.
PubMed 19460188Roiser 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.
PubMed 23481353
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Switching From SSRI to Desvenlafaxine on Cognitive Function In Patients With an Acute Episode of Major Depression
- ClinicalTrials.gov ID
- NCT03432221
- Acronym / sponsor ID
- 2017.116
- Conditions
- Major Depressive Disorder
- Keywords
- Cognition, antidepressants drugs, SNRI, hot cognition, functioning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 3 Jun 2019 (estimated)
- Study completion
- 3 Jun 2019 (estimated)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDD | – | Drug: DesvenlafaxinePatients 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. |
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesvenlafaxinePatients 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. | Drug | MDD |
Primary outcome
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))
15 secondary outcomes
Subjective cognitive function
Time frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week
Attention
Time frame: Baseline and after 12 weeks
Processing speed
Time frame: Baseline and after 12 weeks
Verbal Memory
Time frame: Baseline and after 12 weeks
Executive Functions
Time frame: Baseline and after 12 weeks
Hot cognition
Time frame: Baseline and after 12 weeks
Intelligence quotient
Time frame: Baseline
Depressive symptoms
Time frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week
Anxiety symptoms
Time frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week
Severity and improvement of depression
Time frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week
Self-perceived remission status
Time frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week
Disability
Time frame: Baseline and after 12 weeks
Functioning
Time frame: Baseline and after 12 weeks
Sexual dysfunction
Time frame: Baseline and after 12 weeks
Side effect rating scale for psychotropic drugs
Time frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Background: PubMed 20138370Baune 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.
- Background: PubMed 23098294Bora 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.
- Background: PubMed 12490769Ferguson 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.
- Background: PubMed 19826496Hammar 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.
- Background: PubMed 19896719Herrera-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.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Narcís Cardoner, MD, PhD (0034 93 723 10 10 ext. 22205, ncardoner@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite cognitive measure (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03432221, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.