DepressionDEPREDICTNCT03690856
Clinical and Neurobiological Profile Predictive of Pejorative Outcome of Depression
A study testing inflammatory, neuropsychological and neuroimaging assessment in people with Depression, run by Rennes University Hospital at 8 sites in France.
Trial summary
Depression is a frequent disease which can be marked by therapeutic resistance. It is described as one of the most disabling disease with high cost for society. World Health Organization pointed out that 350 million people are suffering from depression in the world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- inflammatory, neuropsychological and neuroimaging assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 8 sitesFrance
- Study dates
- 8 Nov 2019to 2 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women older than 18 years-old;
- Suffering from a Mood Depressive Episode ( according to DSM IV criteria), and-or Mood Depressive recurrent depression (unipolar or bipolar) (<at stage 3 of Thase and Rush). Treatment resistance will be assessed using Thase an Rush Classification and measured with Maudsley Staging Method (Fekadu et al., 2009);
- MADRS score 15;
- Capacity for the patient to receive information on protocol;
- Patient who gave their consent to the protocol.
Who cannot join
- Contra-indication to MRI
- Patients under social protection or hospitalized without their consent
- Patients suffering from a psychiatric comorbidity such as: schizophrenia, schizo-affective disorder, personality disorder, actual addiction, anorexia-bulimia, obsessive-compulsive disorder;
- Patients suffering from severe intercurrent disease with health prognosis engaged;
- Patients suffering from neurological comorbidity such as: any neurodegenerative disorder (Alzheimer disease, Parkinson disease, Lewy's body disease, multiple sclerosis), any intracranial expansive process.
- Patients with an history of severe cranial injury (with coma);
- Patients with abnormal cerebral MRI.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU angers
Angers, 49933
CHU de Brest - Hôpital de Bohars
Brest, 29820
CHU de Nantes - Hotel-Dieu
Nantes, 44000
CH Henri Laborit
Poitiers, 86021
CH Guillaume Regnier
Rennes, 35000
EPSM du Morbihan
Saint-Avé, 56896
CH Saint-Malo
St-Malo, 35400
CHU de Tours, Clinique Psychiatrique Universitaire
Tours, 37044
About this study
Official title: DEPREDICT: Clinical and Neurobiological Profile Predictive of Pejorative Outcome of Depression
Depression is a frequent disease which can be marked by therapeutic resistance. It is described as one of the most disabling disease with high cost for society. World Health Organization pointed out that 350 million people are suffering from depression in the world. This pathology is considered underdiagnosed, with inadequate care resources and stigmatization.
There is a wide range of evidence in current literature that anxiety is one of the most important factors involved in biological mechanism of treatment resistance in depression. To date, there is a lack of knowledge on this topic. A better understanding of the role of anxiety in the maintenance of depressive state will allow to i) identify quickly and more accurately patients at risk of pejorative evolution and ii) develop specific therapeutics targeting this dimension which remain badly controlled with actual therapeutics.
- Conditions
- Depression
- Being tested
- inflammatory, neuropsychological and neuroimaging assessment
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inflammatory, neuropsychological and neuroimaging assessmentOther
Acts add by research:
pregnancy test; Centralized: IL1, IL6, TNF
Neuropsychologic tests at M6 and M24:
Edinburgh Ladder Lateral Test, Direct and Inverse Verbal Empan, Matrices (WAIS IV), Similarities (WAIS IV), Vertebral fluences, STROOP test, TMT test (Delis Kaplan), WCST test, CPT III, WAIS IV (code)
| Study group | Role | What they receive |
|---|---|---|
| depressiv people | Experimental | Not described Receives: Other: inflammatory, neuropsychological and neuroimaging assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS Scale
Montgomery Äsberg Depression Rating Scale (MADRS): is a scale of depression (diagnosis + follow-up evolution, therapeutic response criteria). It consists of 10 items rated from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum depression intensity). Items evaluate: apparent sadness, expressed sadness, inner tension, reduced sleep, reduced appetite, difficulty concentrating, weariness, inability to feel, pessimistic thoughts, thoughts of suicide ;
Measured: at 36 months
STAI YB
STAI (State Trait Anxiety Inventory) form A and B: is an anxiety scale. The first part concerns state anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (not at all, little, moderately, much) his current anxiety level. The second part concerns trait anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (almost never, sometimes, often, almost always) his level of background anxiety. Two scores varying between 10 (minimum anxiety) and 40 (maximum anxiety) are therefore obtained;
Measured: at baseline.
Secondary outcomes (20)
MADRS Scale
Montgomery Äsberg Depression Rating Scale (MADRS): is a scale of depression (diagnosis + follow-up evolution, therapeutic response criteria). It consists of 10 items rated from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum depression intensity). Items evaluate: apparent sadness, expressed sadness, inner tension, reduced sleep, reduced appetite, difficulty concentrating, weariness, inability to feel, pessimistic thoughts, thoughts of suicide ;
Measured: at 6, 12, 24 months
MSM
Maudsley Staging Method (MSM): The Maudsley method allows an evaluation of the degree of pharmacological resistance integrating the main parameters related to the notion of resistance (duration, initial severity of depression, number and types of treatments tested). A treatment must be prescribed at least 6 weeks to be considered as adequate and according to the observed situations an overall score is determined. A score between 3 and 6 characterizes a mild resistance, between 7 and 10, moderate and finally 11 to 15, severe.
Measured: at 6, 12, 24, 36 months
AES
Apathy Assessment Scale (AES) is a scale that evaluates apathy. This is a hetero rating scale from a semi-structured interview by a trained clinician. It has 18 items from 1 (the item is not present) to 4 (the item is very severe). She evaluates cognitive, emotional and behavioral apathy as well as three items of various apathy. The total score ranges from 18 (total absence of apathy) to 72;
Measured: at 6, 12, 24, 36 months
ERD
Depressive Deceleration Scale (DRE): is an instrument that measures the different aspects of idiopathic slowdown related to depression. The specialist evaluates 16 symptoms and scores each of them according to the following rating: 0-normal, 1-doubt on the pathological character of the phenomenon observed, 2-pathological but discrete sign, 3-obvious for any observer, 4-massive;
Measured: at 6, 12, 24, 36 months
YMRS
Young Mania Rating Scale (YMRS): is a scale published in 1978. It is composed of 11 items. It allows to detect and measure the severity of hypomanic episodes in patients with mood disorders. The assessment is based on the patient's condition within 48 hours before the interview and also during the interview. 4 items are rated out of 8 (irritability, speech, idiotic content, aggressive or unstable behavior) and 7 of 4 rated items (mood, motor activity, sleep, interest in sexuality, thinking disorders, presentation, insight );
Measured: at 6, 12, 24, 36 months
MADRS
Montgomery Äsberg Depression Rating Scale (MADRS): is a scale of depression (diagnosis + follow-up evolution, therapeutic response criteria). It consists of 10 items rated from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum depression intensity). Items evaluate: apparent sadness, expressed sadness, inner tension, reduced sleep, reduced appetite, difficulty concentrating, weariness, inability to feel, pessimistic thoughts, thoughts of suicide ;
Measured: at 6, 12, 24, 36 months
STAI
STAI (State Trait Anxiety Inventory) form A and B: is an anxiety scale. The first part concerns state anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (not at all, little, moderately, much) his current anxiety level. The second part concerns trait anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (almost never, sometimes, often, almost always) his level of background anxiety. Two scores varying between 10 (minimum anxiety) and 40 (maximum anxiety) are therefore obtained;
Measured: at 6, 12, 24, 36 months
Beck
Short Beck Questionnaire: is a self-assessment scale. The subject is asked to complete the questionnaire by circling the number corresponding to the chosen proposal. It can surround, in a series, several numbers if several propositions are suitable. Each item consists of 4 sentences corresponding to 4 degrees of increasing intensity of a symptom: from 0 to 3. In the stripping, it is necessary to take into account the strongest coast chosen for the same series. The overall score is obtained by adding the scores of the 13 items. The range of the scale is from 0 to 39. The higher the score, the more the subject is depressed.
Measured: at 6, 12, 24, 36 months
SHAPS
SHAPS (Snaith-Hamilton Pleasure Scale, 1995): is a scale that evaluates anhedonia, that is to say the loss of pleasure - among other things in patients with depressive syndrome. This self-questionnaire contains 14 items. The patient is offered 4 types of answers: strongly disagree, disagree, agree, strongly agree. The subjects who complete this ladder are invited to answer based on the ability to experience pleasure in the last days. SHAPS was validated in French in 1997.
Measured: at 6, 12, 24, 36 months
HAMA
HAMA (Hamilton Scale): is a scale of appreciation for anxiety. It has been widely used in clinical trials since 1959. It was translated into French by P. Pichot in 1982. The HAMA includes 14 items covering all areas of psychic anxiety, somatic muscle and visceral disorders cognitive and sleep, depressed mood. Each item is rated from 0 to 4 from the absence to the maximum incapacitating intensity. The overall score ranges from 0 to 60. The evaluator, depending on the items, will take into account the 7 days preceding the interview and the day of the interview included. The contributor is asked to choose the intensity that best suits the patient's clinical condition.
Measured: at 6, 12, 24, 36 months
CGI
CGI (Clinical Global Impression): are three scales that evaluate punctually the severity of the disease, the evaluation of overall improvement and the measurement of the therapeutic index. These three scales were developed as part of the research on schizophrenia and the effect of drugs. These global clinical impressions, however, are not reserved for a specific type of pathology. The first CGI is scored from 0 to 7, 0 corresponding to not evaluated, 1 corresponding to normal, 7 corresponding to among the sickest patients. The second CGI is rated from 0 to 7, 0 corresponding to not evaluated, 1 corresponding to very strongly improved, 7 corresponding to very strongly aggravated. The third CGI for the therapeutic index evaluates the therapeutic effect and the side effects. The CGI are fast (5 minutes).
The longitudinal clinical evolution will be evaluated by:
- CGI severity
- CGI answer
Measured: at 6, 12, 24, 36 months
Edinburgh Laterality Test
Edinburgh Ladder Laterality Test: Assessment of Lateralization. Self-questionnaire with 10 items on the habits of use (right hand or left) for different activities (writing, drawing, throwing, cutting, combing, brushing, cutting, taking a spoon, use of a hammer, screwing ). It allows to calculate a ratio D-G / D + G. According to this ratio, the right or left lateralization is defined;
Measured: at 6, 12, 24, 36 months
Empan
Verbal direct and reverse pitch: measurement of the functioning of the phonological loop (short-term memory) and the central administrator (working memory). The experimenter pronounces series of numbers of increasing size (starting with two-digit series) that the participant must repeat in the same order (for the verbal span location) or in reverse order (for the verbal span) reverse). The examiner notes the maximum size of the correctly recalled series of digits for both types of empan;
Measured: at 6, 12, 24, 36 months
Mattis Scale
Mattis scale: evaluation of cognitive functions. This scale evaluates, from several simple neuropsychological tests, the attention, the initiation, the visuo-constructive capacities, the conceptualization, the temporo-spatial orientation, the mnemic capacities of free recall and recognition. His total score is 144 points. The score is corrected according to age and cultural level;
Measured: at 6, 12, 24, 36 months
Verbal fluences
Verbal fluences: This test tests the action planning abilities, the implementation of semantic memory search strategies and the oral language. The subject has two minutes to give as many words as possible starting with the letter P or in the category of animals. We record the total number of words generated in two minutes in thirty-second increments for each of these conditions.
Measured: at 6, 12, 24, 36 months
Stroop Test
STROOP test: evaluation of executive functions. This test evaluates the resistance to interference, ie the ability of the patient to inhibit some over-learned and automated responses. It consists of three parts: color denomination where the subject must name the color (red, green or blue) of rectangles presented on a board, reading words where the subject must read names of color (red, green or blue) that appear in black characters on a second board and interference where the subject must name the color printed without reading the color name written on a third board. Each board has 100 items. The participant must read column by column. We report for each board the number of correctly named items in 45 seconds. We also calculate an interference index.
Measured: at 6, 12, 24, 36 months
Trail Making Test(TMT) Part A and B
Trail Making Test (TMT) part A and B: evaluation of executive functions. This test assesses mental flexibility and visual exploration capabilities. It is divided into two parts. In Part A, the patient must link the figures in ascending order as quickly as possible. In Part B, the patient must link the numbers and letters in ascending order by following an alternating rule. The time (in seconds) put by the participant to take part A and B and the number of errors will be recorded. For Part B, the examiner also records the number of perseveration errors, that is, when the participant did not follow the alternation rule. Finally, the examiner makes a calculation (time taken for Part A subtracted from the time taken for Part B) to tell whether the participant has a mental flexibility disorder.
The oral version of this test (Oral Trail Making Test, TMT) will be used for patients over 65 years old with cognitive impairment prior to the depressive episode.
Measured: at 6, 12, 24, 36 months
MCST
Modified Card Sorting test (MCST): assessment of the capacities of conceptualization, attention and mental flexibility. It consists in proposing to the participant a classification of cards according to rules which he must find himself. There are three ranking possibilities that the participant must repeat twice after holding each ranking for six cards. The examiner records the number of correctly found and maintained categories, the total number of errors and the number of perseverative errors.
Measured: at 6, 12, 24, 36 months
CPT III
CPT III (Continuous Performance Test III): assessment of the patient's attentional abilities. This tool is computerized. It is suggested to the patient to hold his attention for 20 minutes. Letters appear on a screen at different speeds and rhythms. The patient must click on the space bar as quickly as possible at each appearance of letters except when the letter X is displayed. The scores evaluate the reaction time as well as the number of errors.
Measured: at 6, 12, 24, 36 months
IRM
Neuroimaging
Measured: At baseline and at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start8 Nov 2019
- Primary completion2 Feb 2028 (estimated)
- Study completion2 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690856
- Sponsor's protocol ID
- 35RC17_8838_DEPREDICT
- Acronym
- DEPREDICT
- Status last verified
- Jun 2026
- First submitted
- 18 Sep 2018
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEPREDICT: Clinical and Neurobiological Profile Predictive of Pejorative Outcome of Depression
- ClinicalTrials.gov ID
- NCT03690856
- Acronym / sponsor ID
- DEPREDICT / 35RC17_8838_DEPREDICT
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 2 Feb 2028 (estimated)
- Study completion
- 2 Feb 2028 (estimated)
- First posted
- 1 Oct 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.
Depression is a frequent disease which can be marked by therapeutic resistance. It is described as one of the most disabling disease with high cost for society. World Health Organization pointed out that 350 million people are suffering from depression in the world. This pathology is considered underdiagnosed, with inadequate care resources and stigmatization.
There is a wide range of evidence in current literature that anxiety is one of the most important factors involved in biological mechanism of treatment resistance in depression. To date, there is a lack of knowledge on this topic. A better understanding of the role of anxiety in the maintenance of depressive state will allow to i) identify quickly and more accurately patients at risk of pejorative evolution and ii) develop specific therapeutics targeting this dimension which remain badly controlled with actual therapeutics.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| depressiv people | Experimental | Other: inflammatory, neuropsychological and neuroimaging assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women older than 18 years-old;
- Suffering from a Mood Depressive Episode ( according to DSM IV criteria), and-or Mood Depressive recurrent depression (unipolar or bipolar) (<at stage 3 of Thase and Rush). Treatment resistance will be assessed using Thase an Rush Classification and measured with Maudsley Staging Method (Fekadu et al., 2009);
- MADRS score 15;
- Capacity for the patient to receive information on protocol;
- Patient who gave their consent to the protocol.
Key exclusion criteria (7 listed)
- Contra-indication to MRI
- Patients under social protection or hospitalized without their consent
- Patients suffering from a psychiatric comorbidity such as: schizophrenia, schizo-affective disorder, personality disorder, actual addiction, anorexia-bulimia, obsessive-compulsive disorder;
- Patients suffering from severe intercurrent disease with health prognosis engaged;
- Patients suffering from neurological comorbidity such as: any neurodegenerative disorder (Alzheimer disease, Parkinson disease, Lewy's body disease, multiple sclerosis), any intracranial expansive process.
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 |
|---|---|---|
| inflammatory, neuropsychological and neuroimaging assessmentActs add by research: pregnancy test; Centralized: IL1, IL6, TNF Neuropsychologic tests at M6 and M24: Edinburgh Ladder Lateral Test, Direct and Inverse Verbal Empan, Matrices (WAIS IV), Similarities (WAIS IV), Vertebral fluences, STROOP test, TMT test (Delis Kaplan), WCST test, CPT III, WAIS IV (code) | Other | depressiv people |
Primary outcome
MADRS Scale
Time frame: at 36 months
Montgomery Äsberg Depression Rating Scale (MADRS): is a scale of depression (diagnosis + follow-up evolution, therapeutic response criteria). It consists of 10 items rated from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum depression intensity). Items evaluate: apparent sadness, expressed sadness, inner tension, reduced sleep, reduced appetite, difficulty concentrating, weariness, inability to feel, pessimistic thoughts, thoughts of suicide ;
STAI YB
Time frame: at baseline.
STAI (State Trait Anxiety Inventory) form A and B: is an anxiety scale. The first part concerns state anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (not at all, little, moderately, much) his current anxiety level. The second part concerns trait anxiety and consists of a self-questionnaire of 20 items, the subject having to score on a 4-point Likert scale (almost never, sometimes, often, almost always) his level of background anxiety. Two scores varying between 10 (minimum anxiety) and 40 (maximum anxiety) are therefore obtained;
20 secondary outcomes
MADRS Scale
Time frame: at 6, 12, 24 months
MSM
Time frame: at 6, 12, 24, 36 months
AES
Time frame: at 6, 12, 24, 36 months
ERD
Time frame: at 6, 12, 24, 36 months
YMRS
Time frame: at 6, 12, 24, 36 months
MADRS
Time frame: at 6, 12, 24, 36 months
STAI
Time frame: at 6, 12, 24, 36 months
Beck
Time frame: at 6, 12, 24, 36 months
SHAPS
Time frame: at 6, 12, 24, 36 months
HAMA
Time frame: at 6, 12, 24, 36 months
CGI
Time frame: at 6, 12, 24, 36 months
Edinburgh Laterality Test
Time frame: at 6, 12, 24, 36 months
Empan
Time frame: at 6, 12, 24, 36 months
Mattis Scale
Time frame: at 6, 12, 24, 36 months
Verbal fluences
Time frame: at 6, 12, 24, 36 months
Stroop Test
Time frame: at 6, 12, 24, 36 months
Trail Making Test(TMT) Part A and B
Time frame: at 6, 12, 24, 36 months
MCST
Time frame: at 6, 12, 24, 36 months
CPT III
Time frame: at 6, 12, 24, 36 months
IRM
Time frame: At baseline and at 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inflammatory, neuropsychological and neuroimaging assessment in people with Depression, run by Rennes University Hospital at 8 sites in France.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADRS Scale (time frame: at 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.