Treatment-resistant Bipolar DepressionPhase 1NCT03522545
Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression
A Phase 1 study testing Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) in people with Treatment-resistant Bipolar Depression, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The overall objective of the investigators is to assess the therapeutic efficacy and tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment-resistant Bipolar Depression
- What is being tested?
- Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2022to 1 Dec 2026
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of DSM-IV-TR of Bipolar I or Bipolar II disorder as verified by the semi-structured diagnostic interviews SCID. The diagnosis may be supported by information from significant others, and from hospital records.
- Age: 18-65 years
- Severity: meet DSM-IV-TR criteria of depressive episode and MADRS of 25 or above
- Treatment resistance: None response to two trials (during lifetime) with mood stabilizers with proven efficacy in bipolar depression (lithium, lamotrigine, quetiapine, olanzapine) and/or antidepressants.
- a A trial is defined as at least 6 weeks in adequate or tolerated dose as reported by the patient, or patients that have been unable to comply with 6 weeks trials of mood stabilizer or an antidepressant.
- b None response: Less than 50% reduction in MADRS values or still meet DSM-IV-TR criteria of depressive episode
Show all 11Show fewer
- CRP concentration greater than 5 mg/L
- Female subjects whom are not pregnant, not breastfeeding, and not planning on becoming pregnant during the study. Female patients of childbearing potential must be using a reliable method of contraception.
- Patient competent to give informed consent according to the judgment of the clinician
- Written informed consent
- Patient sufficiently fluent in English language to ensure valid responses to psychometric testing (needed for validated neurocognitive outcomes testing)
Who cannot join
- MSCs transplant within the last six months
- Inability to comply with study protocol
- Patient at high suicidal risk according to clinicians' judgement
- History of previous brain injury; neurologic impairment and/or deficit; seizure disorder requiring anti-convulsant therapy; renal disease or altered renal function as defined by serum creatinine 2x ULN at admission; hepatic disease or altered liver function as defined by SGPT > 2 x ULN (non-contusion related), and/or T. Bilirubin 1.5 x ULN at admission; immunosuppression as defined by WBC<3,000 cells/ml at admission; HIV, splenectomy or cancer
- Unstable serious medical conditions, including clinically relevant laboratory abnormalities. Conditions that affect neuropsychological assessment such as Parkinson's Disease, Multiple sclerosis, stroke, alcohol and substance abuse or dependence (according to SCID or DSM-IV-TR). Other serious medical illness that is not adequately controlled and, in the investigator's opinion, would not permit the subject to be managed according to the protocol.
- Hemodynamic instability at the time of MSCs infusion.
- Positive pregnancy test (at screening or baseline visits).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77054
Dana Razouq, (713) 486-2523, Dana.Razouq@uth.tmc.edu
About this study
The overall objective of the investigators is to assess the therapeutic efficacy and tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD).
Read the detailed description
This clinical trial is a randomized, double-blind, placebo-controlled study aiming to study the efficacy and side effects of MSCs adjunctive to TAU compared to a normal saline solution in patients with TRBD. Relevant patients with bipolar depression will be addressed in order to establish whether they are willing to be screened for the study. The patients must be assigned a patient number and sign the consent form after receiving oral and written information about the study prior to undergoing any study procedures.
MSCs will be infused as a single dose up to one week after the inclusion of the patient. The treatment trial lasts eight weeks. Of note, the investigators will assess patients also at week 26 with a neurocognitive and clinical battery. It will not be allowed changes in psychiatric medication during this period. If a patient or the treating clinician decides that the patient could receive better treatment outside of the study, the patient may leave the study at all times, as specified in the informed consent. Patients were not allowed to take nonsteroidal or steroidal anti-inflammatory medications during the study. Medications for hypertension, diabetes, hypothyroidism, allergies, infections, or other medical conditions were allowed as dictated by the patients' treating physicians. The investigators defined refractory bipolar depression as depression that failed to respond to two trials (during lifetime) with antidepressants and/or mood stabilizer with proven efficacy in bipolar depression (lithium, lamotrigine, quetiapine, lurasidone, olanzapine) in adequate doses for at least 6 weeks or until cessation of treatment due to side effects (Schoeyen et al., 2015).
After the initial injection, patients will continue maintenance treatment with their current psychiatrist. During this time, they will not receive additional injections but will receive treatment as usual per their clinician's choice. Patients will remain on stable psychiatric medications during this period. If patients need to change medications, they will be removed from the study protocol.
- Conditions
- Treatment-resistant Bipolar Depression
- Being tested
- Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs), Placebo
- Keywords
- treatment-resistant bipolar depression, bipolar disorder, manic depression
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)Biological
Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow
PlaceboBiological
Placebo for Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal | Experimental | Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow |
| Placebo | Placebo comparator | Placebo for Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a short and reliable scale devised to be sensitive to change. Patients are rated on ten items, each of which has value ranges from 0 (the least pathology) to 6 (the most sever pathology). Sum scores range from 0 to 60, with a scoring of 20 indicating moderate and 30 severe depression. The scale is sensitive to change and covers many, but not all, symptom domains in depression.
Measured: baseline, week 8, week 26
Secondary outcomes (15)
Change in Functional impairment as assessed by the Functioning Assessment Short Test (FAST)
The Functioning Assessment Short Test (FAST) assesses functional impairment. FAST is a 24-item scale and assesses six functional domains: autonomy, occupational functioning, cognitive, financial issues, interpersonal relationships, and leisure time. Higher scores indicate higher degrees of functional impairment.
Measured: baseline, week 26
Change in Overall functioning in living as assessed by the Global Assessment of Functioning (GAF)
The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. The scale is presented and described in the DSM-IV-TR on page 34.
Measured: baseline, week 26
Change in Clinical Global Impression Scale for Bipolar illness (CGI-BP), severity of mania subscale
The Clinical Global Impression Scale for bipolar lllness (CGI-BP) is a modification of the CGI specifically for use in assessing global illness severity and change in patients with bipolar disorder (BD). The revised scale and manual provide a focused set of instructions to facilitate the reliability of these ratings of mania, depression, and overall bipolar illness during treatment of an acute episode or in longer-term illness prophylaxis. The clinician forms a global judgment both of the severity of the illness as compared to other cases with the same diagnosis and the global degree of change during treatment. There are 3 subscales (severity of mania, severity of depression, severity overall); and each subscale has a range of values from 1 (best) to 7 (worst).
Measured: baseline, week 26
Change in Clinical Global Impression Scale for Bipolar illness (CGI-BP), severity of depression subscale
The Clinical Global Impression Scale for bipolar lllness (CGI-BP) is a modification of the CGI specifically for use in assessing global illness severity and change in patients with bipolar disorder (BD). The revised scale and manual provide a focused set of instructions to facilitate the reliability of these ratings of mania, depression, and overall bipolar illness during treatment of an acute episode or in longer-term illness prophylaxis. The clinician forms a global judgment both of the severity of the illness as compared to other cases with the same diagnosis and the global degree of change during treatment. There are 3 subscales (severity of mania, severity of depression, severity overall); and each subscale has a range of values from 1 (best) to 7 (worst).
Measured: baseline, week 26
Change in Clinical Global Impression Scale for Bipolar illness (CGI-BP), severity overall subscale
The Clinical Global Impression Scale for bipolar lllness (CGI-BP) is a modification of the CGI specifically for use in assessing global illness severity and change in patients with bipolar disorder (BD). The revised scale and manual provide a focused set of instructions to facilitate the reliability of these ratings of mania, depression, and overall bipolar illness during treatment of an acute episode or in longer-term illness prophylaxis. The clinician forms a global judgment both of the severity of the illness as compared to other cases with the same diagnosis and the global degree of change during treatment. There are 3 subscales (severity of mania, severity of depression, severity overall); and each subscale has a range of values from 1 (best) to 7 (worst).
Measured: baseline, week 26
Change in neurocognition as assessed by the California Verbal Learning Test
California Verbal Learning Test (second edition (CVLT-II)). The adult version was chosen because it is one of the most widely used neuropsychological tests. This test consists of verbal list learning and memory test.
Measured: baseline, week 26
Change in problem-solving ability as assessed by the Wisconsin Card Sorting Test (WCST)
The Wisconsin Card Sorting Test (WCST) assesses problem-solving ability and is thought to be an index of functioning of the prefrontal cortex. The task requires subjects to match cards to one of four target cards according to a certain sorting rule (color, shape or number) without explicit instructions regarding the nature of the sorting rule. After 10 consecutive matches, the sorting rule changes without warning, and the subject needs to determine the new principle. Perseverative errors and number of categories achieved will be used as dependent measures.
Measured: baseline, week 26
Number of participants with inflammatory markers as assessed by multiplex biomarker analysis
The Bioplex 200 (Bio-Rad) will be used for multiplex biomarker analysis.
Measured: baseline
Number of participants with inflammatory markers as assessed by multiplex biomarker analysis
The Bioplex 200 (Bio-Rad) will be used for multiplex biomarker analysis.
Measured: week 26
Change in brain-derived neurotrophic factor (BDNF) level as assessed by enzyme-linked immunosorbent assay (ELISA)
Measured: baseline, week 26
Change in C-reactive protein (CRP) level as assessed by enzyme-linked immunosorbent assay (ELISA)
Measured: baseline, week 26
Number of participants with a change in brain activity between baseline and week 26 as assessed by Magnetic Resonance Imaging (MRI)
Measured: baseline, week 26
Number of participants who withdrawal due to Adverse Events (AEs)
Measured: week 26
Number of participants with suicidal ideation based on clinical assessment
Measured: week 26
Number of participants with treatment emergent mania or hypomania as assessed by the Young Mania Rating Scale (YMRS) and clinical assessment
The YMRS is an 11-item scale that is used to assess the severity of mania. Each item is given a severity rating--four items are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items (irritability, speech, thought content, and disruptive/aggressive behavior) are given twice the weight of the others to compensate for poor cooperation from severely ill patients.
Measured: week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start20 Apr 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-resistant Bipolar DepressionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jair Soares, The University of Texas Health Science Center, Houston
- Investigators
- Jair C Soares, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522545
- Sponsor's protocol ID
- HSC-MS-16-0657
- Status last verified
- Jun 2025
- First submitted
- 29 Mar 2018
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression
- ClinicalTrials.gov ID
- NCT03522545
- Acronym / sponsor ID
- HSC-MS-16-0657
- Conditions
- Treatment-resistant Bipolar Depression
- Keywords
- treatment-resistant bipolar depression, bipolar disorder, manic depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 11 May 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.
The overall objective of the investigators is to assess the therapeutic efficacy and tolerability of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow for treatment of treatment-resistant bipolar depression patient (TRBD).
Detailed description
This clinical trial is a randomized, double-blind, placebo-controlled study aiming to study the efficacy and side effects of MSCs adjunctive to TAU compared to a normal saline solution in patients with TRBD. Relevant patients with bipolar depression will be addressed in order to establish whether they are willing to be screened for the study. The patients must be assigned a patient number and sign the consent form after receiving oral and written information about the study prior to undergoing any study procedures.
MSCs will be infused as a single dose up to one week after the inclusion of the patient. The treatment trial lasts eight weeks. Of note, the investigators will assess patients also at week 26 with a neurocognitive and clinical battery. It will not be allowed changes in psychiatric medication during this period. If a patient or the treating clinician decides that the patient could receive better treatment outside of the study, the patient may leave the study at all times, as specified in the informed consent. Patients were not allowed to take nonsteroidal or steroidal anti-inflammatory medications during the study. Medications for hypertension, diabetes, hypothyroidism, allergies, infections, or other medical conditions were allowed as dictated by the patients' treating physicians. The investigators defined refractory bipolar depression as depression that failed to respond to two trials (during lifetime) with antidepressants and/or mood stabilizer with proven efficacy in bipolar depression (lithium, lamotrigine, quetiapine, lurasidone, olanzapine) in adequate doses for at least 6 weeks or until cessation of treatment due to side effects (Schoeyen et al., 2015).
After the initial injection, patients will continue maintenance treatment with their current psychiatrist. During this time, they will not receive additional injections but will receive treatment as usual per their clinician's choice. Patients will remain on stable psychiatric medications during this period. If patients need to change medications, they will be removed from the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal | Experimental | –Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo for Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of DSM-IV-TR of Bipolar I or Bipolar II disorder as verified by the semi-structured diagnostic interviews SCID. The diagnosis may be supported by information from significant others, and from hospital records.
- Age: 18-65 years
- Severity: meet DSM-IV-TR criteria of depressive episode and MADRS of 25 or above
- Treatment resistance: None response to two trials (during lifetime) with mood stabilizers with proven efficacy in bipolar depression (lithium, lamotrigine, quetiapine, olanzapine) and/or antidepressants.
- a A trial is defined as at least 6 weeks in adequate or tolerated dose as reported by the patient, or patients that have been unable to comply with 6 weeks trials of mood stabilizer or an antidepressant.
Key exclusion criteria (7 listed)
- MSCs transplant within the last six months
- Inability to comply with study protocol
- Patient at high suicidal risk according to clinicians' judgement
- History of previous brain injury; neurologic impairment and/or deficit; seizure disorder requiring anti-convulsant therapy; renal disease or altered renal function as defined by serum creatinine 2x ULN at admission; hepatic disease or altered liver function as defined by SGPT > 2 x ULN (non-contusion related), and/or T. Bilirubin 1.5 x ULN at admission; immunosuppression as defined by WBC<3,000 cells/ml at admission; HIV, splenectomy or cancer
- Unstable serious medical conditions, including clinically relevant laboratory abnormalities. Conditions that affect neuropsychological assessment such as Parkinson's Disease, Multiple sclerosis, stroke, alcohol and substance abuse or dependence (according to SCID or DSM-IV-TR). Other serious medical illness that is not adequately controlled and, in the investigator's opinion, would not permit the subject to be managed according to the protocol.
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 |
|---|---|---|
| Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow | Biological | – |
| PlaceboPlacebo for Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) | Biological | Placebo |
Primary outcome
Change in depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: baseline, week 8, week 26
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a short and reliable scale devised to be sensitive to change. Patients are rated on ten items, each of which has value ranges from 0 (the least pathology) to 6 (the most sever pathology). Sum scores range from 0 to 60, with a scoring of 20 indicating moderate and 30 severe depression. The scale is sensitive to change and covers many, but not all, symptom domains in depression.
15 secondary outcomes
Change in Functional impairment as assessed by the Functioning Assessment Short Test (FAST)
Time frame: baseline, week 26
Change in Overall functioning in living as assessed by the Global Assessment of Functioning (GAF)
Time frame: baseline, week 26
Change in Clinical Global Impression Scale for Bipolar illness (CGI-BP), severity of mania subscale
Time frame: baseline, week 26
Change in Clinical Global Impression Scale for Bipolar illness (CGI-BP), severity of depression subscale
Time frame: baseline, week 26
Change in Clinical Global Impression Scale for Bipolar illness (CGI-BP), severity overall subscale
Time frame: baseline, week 26
Change in neurocognition as assessed by the California Verbal Learning Test
Time frame: baseline, week 26
Change in problem-solving ability as assessed by the Wisconsin Card Sorting Test (WCST)
Time frame: baseline, week 26
Number of participants with inflammatory markers as assessed by multiplex biomarker analysis
Time frame: baseline
Number of participants with inflammatory markers as assessed by multiplex biomarker analysis
Time frame: week 26
Change in brain-derived neurotrophic factor (BDNF) level as assessed by enzyme-linked immunosorbent assay (ELISA)
Time frame: baseline, week 26
Change in C-reactive protein (CRP) level as assessed by enzyme-linked immunosorbent assay (ELISA)
Time frame: baseline, week 26
Number of participants with a change in brain activity between baseline and week 26 as assessed by Magnetic Resonance Imaging (MRI)
Time frame: baseline, week 26
Number of participants who withdrawal due to Adverse Events (AEs)
Time frame: week 26
Number of participants with suicidal ideation based on clinical assessment
Time frame: week 26
Number of participants with treatment emergent mania or hypomania as assessed by the Young Mania Rating Scale (YMRS) and clinical assessment
Time frame: week 26
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 22 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Treatment-resistant Bipolar Depression
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
Recruiting
Theta-Burst Stimulation for Bipolar Depression
Bipolar Depression, Bipolar Disorder
RecruitingPhase 3
Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression
Bipolar Depression Depressed Phase
Recruiting
Treatment Resistance in Psychiatric Disorders: the Search for Biological Markers Predictive of Response to Treatment
Schizophrenia, Treatment Resistant Depression (TRD)
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.
Jair C Soares, MD, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) in people with Treatment-resistant Bipolar Depression, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 11 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: looking for participants now, as of the sponsor's last update on 22 Jun 2025. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Dana Razouq ((713) 486-2523, Dana.Razouq@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: baseline, week 8, week 26). 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 22 Jun 2025.