Treatment Resistant DepressionPhase 4CBDNCT04732169
Cannabidiol for Treatment Resistant Depression
A Phase 4 study testing Active study drug ( oral CBD) in people with Treatment Resistant Depression, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
With this study, the investigators will address the following scientific aims: 1. Demonstrate the antidepressant effects of CBD in human adults with treatment refractory MDD as measured by standard rating scales. 2. Confirm CBD's safety profile in human adult patients with MDD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Active study drug ( oral CBD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 9 Jul 2021
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old
- Sufficient fluency in English to understand testing procedures and provide written informed consent
- A Hamilton Depression Rating Scale total score greater than 18
- A DSM 5 diagnosis of MDD based on the MINI.
- No evidence of alcohol or other substance use disorder in the past 3 months
- For females: no current pregnancy or lactation (women of reproductive potential must have a negative urine pregnancy test at screening).
- Depressed patients who have failed at least one adequate antidepressant trial during the current depressive episode based on the ATRQ.
Who cannot join
- No diagnosis of other primary psychiatric disorder (defined in this case as being the main focus of treatment) as determined by the MINI, such as: bipolar disorder, personality disorders, psychotic disorders, post-traumatic stress disorder, obsessive-compulsive disorder, dissociative disorders, eating disorder, or cognitive task due to neurological conditions
- Systolic blood pressure < 150 and/or diastolic blood pressure < 90 at screening
- A QTc F< 480 as determined by an ECG
- No post-partum state (being within 2 months of delivery or miscarriage)
- Imminent suicide or homicide risk as determined by the investigator
- No history of using prescription Epidiolex for any indication.
Show all 13Show fewer
- Not being treated with one of the following medications: benzodiazepines or other CNS depressants.
- Not using concomitant medications that are moderate or strong CYP3A4 or CYP2C19 inhibitors.
- None of the following clinically-significant medication condition or therapy that would preclude treatment with ketamine, to include: Recent myocardial infarction, unstable angina, malignant neoplasm in the past 6 months, immunosuppressive or corticosteroid therapy within the last month, with the following exceptions: any inhaled, intranasal, topical or vaginal corticosteroids are allowed, chemotherapy.
- No clinically significant neurological disease based on medical history (e.g., epilepsy) or significant head injury.
- Any of the following disorders: Rheumatoid arthritis; Lupus erythematosus; Autoimmune hepatitis; Autoimmune peripheral neuropathy; Autoimmune pancreatitis; Behcet's disease; Crohn's disease; Autoimmune glomerulonephritis; Grave's disease; Guillain-Barre syndrome; Hashimoto's thyroiditis; Autoimmune polymyositis or polymyalgia; Myasthenia gravis; Narcolepsy; Polyarteritis nodosa; Scleroderma; Sjogren's syndrome; Transverse myelitis; Wegener's granulomatosis; History of seizures (only childhood febrile seizures are allowed)
- The presence of clinically significant laboratory findings in the opinion of the investigator including, but not limited to, clinically significant anemia or transaminase elevation.
- If the UDS is positive, the subject would be excluded if, in the opinion of the investigator, the positive UDS meant the subject has an active substance use disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
With this study, the investigators will address the following scientific aims:
- Demonstrate the antidepressant effects of CBD in human adults with treatment refractory MDD as measured by standard rating scales.
- Confirm CBD's safety profile in human adult patients with MDD.
Read the detailed description
Participants will be medically stable and historically failed to respond to one or more adequate trials of commercially available antidepressant drugs during the current depressive episodes. We plan to administer Epidiolex (CBD) or placebo in double blind, randomized, cross-over fashion to 10 depressed adults with MDD over 16 weeks. The study will use a cross-over design so that each participant serves as their own control. The dosage of CBD or placebo CBD will automatically be titrated up and down during the dosing period. Participants first randomized to CBD will automatically be tapered from CBD and switched to placebo CBD after eight weeks. Participants first randomized to placebo CBD will automatically have an equivalent reduction in placebo CBD and be switched to CBD after eight weeks. During the first week after randomization, participants will receive 125mg of CBD or placebo CBD taken twice daily (250mg/day). During the second week after randomization, the dosage will be increased to 250mg of CBD or placebo CBD taken twice daily (500mg/day) for one week. During the third week after randomization, the dosage will be increased to 500mg of CBD or placebo CBD taken twice daily (1000mg/day). Participants will remain on 1000mg/day of CBD or placebo CBD for four more weeks, at which point they will be stepped down to 500mg/day of CBD or placebo CBD for one week, followed by 250mg/day of CBD or placebo CBD for one week.
Study drug and matching placebo will be prepared by the UAB Investigational Pharmacy. Sesame oil will be used to create the placebo. Both the placebo and the active CBD will be flavored with strawberry flavoring. Study medications will be dispensed at weekly visits and each participant will be given 14 single dose syringes to be taken orally twice a day.
At screening participants will undergo a MINI interview, physical examination, and ECG, vital signs, HDRS-17, MADRS, CSSR-S, ATRQ, SF-36 and CGI-S. Laboratory assessment including CBC with differential, TSH with reflex T4, CMP, UA, and UDS will be done at screening.. At screening, the investigators will also administer the following self-report questionnaires to characterize reward sensitivity and other personality features relevant to anhedonia: Social Anhedonia Scale, the Motivation and Energy Inventory and the Physical Anhedonia Scale. The screening period will last up to one week, at which point subjects will present for a baseline randomization visit.
Participants will be seen on site weekly during the study. Drug effect will be measured using standard rating scales including the HDRS-17, MADRS, SF36, CSSR-S, CGI-I, CGI-S, which will be completed at each visit. The following scales will be completed at every other visit following the screening visit: Social Anhedonia Scale, the Motivation and Energy Inventory and the Physical Anhedonia Scale. At each study visit safety assessments including vital sign assessment and adverse event assessment will be completed. Subjects will also undergo physical examination and an ECG for safety during screening, after 8 weeks of treatment and at the end of 16 weeks of treatment. Laboratory assessment including CBD with differential, CMP, and UA will be done at the 8 week and 16 week visit.
To assess potential changes in cognition while on the study drug/placebo, three computerized tests of cognition will the administered at baseline, Week 8, and Week 16. The Relational \& Item Specific Encoding task (RISE) will probe any potential neural abnormalities. The Probabilistic Learning Task will be used to examine neural circuits related to reward processing in major depression disorder. For the working memory task, participants will be shown two images with objects and asked to decide whether the two images differ or not.
- Conditions
- Treatment Resistant Depression
- Being tested
- Active study drug ( oral CBD), matching placebo
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active study drug ( oral CBD)Drug
CBD in single dose syringes
matching placeboDrug
Placebo made with sesame oil flavored with strawberry flavoring in single dose syringes
| Study group | Role | What they receive |
|---|---|---|
| Epidiolex (cannabidiol) (CBD) | Active comparator | During the first week after randomization, participants will receive 125mg of Epidiolex (CBD) or matching placebo taken twice daily (250mg/day). During the second week after randomization, the dosage will be increased to 250mg of Epidiolex or placebo taken twice daily (500mg/day) for one week. During the third week after randomization, the dosage will be increased to 500mg of Epidiolex (CBD) or matching placebo taken twice daily (1000mg/day). Participants will remain on 1000mg/day of Epidiolex (CBD) or matching placebo for four more weeks, at which point they will be stepped down to 500mg/day of Epidiolex (CBD) or placebo for one week, followed by 250mg/day of Epidiolex (CBD) or placebo for one week. Receives: Drug: Active study drug ( oral CBD) |
| Placebo | Placebo comparator | During the first week after randomization, participants will receive 125mg of Epidiolex (CBD) or matching placebo taken twice daily (250mg/day). During the second week after randomization, the dosage will be increased to 250mg of Epidiolex or placebo taken twice daily (500mg/day) for one week. During the third week after randomization, the dosage will be increased to 500mg of Epidiolex (CBD) or matching placebo taken twice daily (1000mg/day). Participants will remain on 1000mg/day of Epidiolex (CBD) or matching placebo for four more weeks, at which point they will be stepped down to 500mg/day of Epidiolex (CBD) or placebo for one week, followed by 250mg/day of Epidiolex (CBD) or placebo for one week. Receives: Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale- 17
A semi-structured interview focusing on 17 symptoms of depression, range of scores 0-52 with 0 indicating no depression
Measured: Baseline
Hamilton Depression Rating Scale- 17
A semi-structured interview focusing on 17 symptoms of depressionrange of scores 0-52 with 0 indicating no depression,
Measured: Week 8
Hamilton Depression Rating Scale- 17
A semi-structured interview focusing on 17 symptoms of depression, range of scores 0-52 with 0 indicating no depression.
Measured: Week 16
Secondary outcomes (3)
Montgomery Asberg Depression Rating Scale
A 10 item semi-structured interview focusing on symptoms of depression, range of scores 0-60, with 0 indicating no depression
Measured: Baseline
Montgomery Asberg Depression Rating Scale
A 10 item semi-structured interview focusing on symptoms of depression, range of scores 0-60, with 0 indicating no depression
Measured: Week 8
Montgomery Asberg Depression Rating Scale
A 10 item semi-structured interview focusing on symptoms of depression, range of scores 0-60, with 0 indicating no depression
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Jul 2021
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
Why it stopped: Investigator decided not to do study, due to insufficient funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We plan to administer Epidiolex (CBD) or placebo in double blind, randomized, cross-over fashion.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Macaluso, University of Alabama at Birmingham
- Investigators
- Matthew Macaluso, D.O., Principal investigator, University ot Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732169
- Sponsor's protocol ID
- 300006618
- Acronym
- CBD
- Status last verified
- Jul 2021
- First submitted
- 13 Jan 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share protocol, consent, SAP,and CRS. Do not plan to share IPD,
Publications
Greenberg PE, Fournier AA, Sisitsky T, Pike CT, Kessler RC. The economic burden of adults with major depressive disorder in the United States (2005 and 2010). J Clin Psychiatry. 2015 Feb;76(2):155-62. doi: 10.4088/JCP.14m09298.
PubMed 25742202Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.
PubMed 12813115Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M; STAR*D Study Team. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med. 2006 Mar 23;354(12):1231-42. doi: 10.1056/NEJMoa052963.
PubMed 16554525Linge R, Jimenez-Sanchez L, Campa L, Pilar-Cuellar F, Vidal R, Pazos A, Adell A, Diaz A. Cannabidiol induces rapid-acting antidepressant-like effects and enhances cortical 5-HT/glutamate neurotransmission: role of 5-HT1A receptors. Neuropharmacology. 2016 Apr;103:16-26. doi: 10.1016/j.neuropharm.2015.12.017. Epub 2015 Dec 19.
PubMed 26711860Silote GP, Sartim A, Sales A, Eskelund A, Guimaraes FS, Wegener G, Joca S. Emerging evidence for the antidepressant effect of cannabidiol and the underlying molecular mechanisms. J Chem Neuroanat. 2019 Jul;98:104-116. doi: 10.1016/j.jchemneu.2019.04.006. Epub 2019 Apr 27.
PubMed 31039391Gall Z, Farkas S, Albert A, Ferencz E, Vancea S, Urkon M, Kolcsar M. Effects of Chronic Cannabidiol Treatment in the Rat Chronic Unpredictable Mild Stress Model of Depression. Biomolecules. 2020 May 22;10(5):801. doi: 10.3390/biom10050801.
PubMed 32455953Shbiro L, Hen-Shoval D, Hazut N, Rapps K, Dar S, Zalsman G, Mechoulam R, Weller A, Shoval G. Effects of cannabidiol in males and females in two different rat models of depression. Physiol Behav. 2019 Mar 15;201:59-63. doi: 10.1016/j.physbeh.2018.12.019. Epub 2018 Dec 17.
PubMed 30571957Sales AJ, Fogaca MV, Sartim AG, Pereira VS, Wegener G, Guimaraes FS, Joca SRL. Cannabidiol Induces Rapid and Sustained Antidepressant-Like Effects Through Increased BDNF Signaling and Synaptogenesis in the Prefrontal Cortex. Mol Neurobiol. 2019 Feb;56(2):1070-1081. doi: 10.1007/s12035-018-1143-4. Epub 2018 Jun 4.
PubMed 29869197Cuttler C, Spradlin A, McLaughlin RJ. A naturalistic examination of the perceived effects of cannabis on negative affect. J Affect Disord. 2018 Aug 1;235:198-205. doi: 10.1016/j.jad.2018.04.054. Epub 2018 Apr 6.
PubMed 29656267McGuire P, Robson P, Cubala WJ, Vasile D, Morrison PD, Barron R, Taylor A, Wright S. Cannabidiol (CBD) as an Adjunctive Therapy in Schizophrenia: A Multicenter Randomized Controlled Trial. Am J Psychiatry. 2018 Mar 1;175(3):225-231. doi: 10.1176/appi.ajp.2017.17030325. Epub 2017 Dec 15.
PubMed 29241357
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol for Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT04732169
- Acronym / sponsor ID
- CBD / 300006618
- Conditions
- Treatment Resistant Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator decided not to do study, due to insufficient funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 1 Feb 2021 (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.
With this study, the investigators will address the following scientific aims:
- Demonstrate the antidepressant effects of CBD in human adults with treatment refractory MDD as measured by standard rating scales.
- Confirm CBD's safety profile in human adult patients with MDD.
Detailed description
Participants will be medically stable and historically failed to respond to one or more adequate trials of commercially available antidepressant drugs during the current depressive episodes. We plan to administer Epidiolex (CBD) or placebo in double blind, randomized, cross-over fashion to 10 depressed adults with MDD over 16 weeks. The study will use a cross-over design so that each participant serves as their own control. The dosage of CBD or placebo CBD will automatically be titrated up and down during the dosing period. Participants first randomized to CBD will automatically be tapered from CBD and switched to placebo CBD after eight weeks. Participants first randomized to placebo CBD will automatically have an equivalent reduction in placebo CBD and be switched to CBD after eight weeks. During the first week after randomization, participants will receive 125mg of CBD or placebo CBD taken twice daily (250mg/day). During the second week after randomization, the dosage will be increased to 250mg of CBD or placebo CBD taken twice daily (500mg/day) for one week. During the third week after randomization, the dosage will be increased to 500mg of CBD or placebo CBD taken twice daily (1000mg/day). Participants will remain on 1000mg/day of CBD or placebo CBD for four more weeks, at which point they will be stepped down to 500mg/day of CBD or placebo CBD for one week, followed by 250mg/day of CBD or placebo CBD for one week.
Study drug and matching placebo will be prepared by the UAB Investigational Pharmacy. Sesame oil will be used to create the placebo. Both the placebo and the active CBD will be flavored with strawberry flavoring. Study medications will be dispensed at weekly visits and each participant will be given 14 single dose syringes to be taken orally twice a day.
At screening participants will undergo a MINI interview, physical examination, and ECG, vital signs, HDRS-17, MADRS, CSSR-S, ATRQ, SF-36 and CGI-S. Laboratory assessment including CBC with differential, TSH with reflex T4, CMP, UA, and UDS will be done at screening.. At screening, the investigators will also administer the following self-report questionnaires to characterize reward sensitivity and other personality features relevant to anhedonia: Social Anhedonia Scale, the Motivation and Energy Inventory and the Physical Anhedonia Scale. The screening period will last up to one week, at which point subjects will present for a baseline randomization visit.
Participants will be seen on site weekly during the study. Drug effect will be measured using standard rating scales including the HDRS-17, MADRS, SF36, CSSR-S, CGI-I, CGI-S, which will be completed at each visit. The following scales will be completed at every other visit following the screening visit: Social Anhedonia Scale, the Motivation and Energy Inventory and the Physical Anhedonia Scale. At each study visit safety assessments including vital sign assessment and adverse event assessment will be completed. Subjects will also undergo physical examination and an ECG for safety during screening, after 8 weeks of treatment and at the end of 16 weeks of treatment. Laboratory assessment including CBD with differential, CMP, and UA will be done at the 8 week and 16 week visit.
To assess potential changes in cognition while on the study drug/placebo, three computerized tests of cognition will the administered at baseline, Week 8, and Week 16. The Relational \& Item Specific Encoding task (RISE) will probe any potential neural abnormalities. The Probabilistic Learning Task will be used to examine neural circuits related to reward processing in major depression disorder. For the working memory task, participants will be shown two images with objects and asked to decide whether the two images differ or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We plan to administer Epidiolex (CBD) or placebo in double blind, randomized, cross-over fashion.
| Arm | Type | Receives |
|---|---|---|
| Epidiolex (cannabidiol) (CBD) | Active comparator | Drug: Active study drug ( oral CBD)During the first week after randomization, participants will receive 125mg of Epidiolex (CBD) or matching placebo taken twice daily (250mg/day). During the second week after randomization, the dosage will be increased to 250mg of Epidiolex or placebo taken twice daily (500mg/day) for one week. During the third week after randomization, the dosage will be increased to 500mg of Epidiolex (CBD) or matching placebo taken twice daily (1000mg/day). Participants will remain on 1000mg/day of Epidiolex (CBD) or matching placebo for four more weeks, at which point they will be stepped down to 500mg/day of Epidiolex (CBD) or placebo for one week, followed by 250mg/day of Epidiolex (CBD) or placebo for one week. |
| Placebo | Placebo comparator | Drug: matching placeboDuring the first week after randomization, participants will receive 125mg of Epidiolex (CBD) or matching placebo taken twice daily (250mg/day). During the second week after randomization, the dosage will be increased to 250mg of Epidiolex or placebo taken twice daily (500mg/day) for one week. During the third week after randomization, the dosage will be increased to 500mg of Epidiolex (CBD) or matching placebo taken twice daily (1000mg/day). Participants will remain on 1000mg/day of Epidiolex (CBD) or matching placebo for four more weeks, at which point they will be stepped down to 500mg/day of Epidiolex (CBD) or placebo for one week, followed by 250mg/day of Epidiolex (CBD) or placebo for one week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-65 years old
- Sufficient fluency in English to understand testing procedures and provide written informed consent
- A Hamilton Depression Rating Scale total score greater than 18
- A DSM 5 diagnosis of MDD based on the MINI.
- No evidence of alcohol or other substance use disorder in the past 3 months
Key exclusion criteria (13 listed)
- No diagnosis of other primary psychiatric disorder (defined in this case as being the main focus of treatment) as determined by the MINI, such as: bipolar disorder, personality disorders, psychotic disorders, post-traumatic stress disorder, obsessive-compulsive disorder, dissociative disorders, eating disorder, or cognitive task due to neurological conditions
- Systolic blood pressure < 150 and/or diastolic blood pressure < 90 at screening
- A QTc F< 480 as determined by an ECG
- No post-partum state (being within 2 months of delivery or miscarriage)
- Imminent suicide or homicide risk as determined by the investigator
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 |
|---|---|---|
| Active study drug ( oral CBD)CBD in single dose syringes | Drug | Epidiolex (cannabidiol) (CBD) |
| matching placeboPlacebo made with sesame oil flavored with strawberry flavoring in single dose syringes | Drug | Placebo |
Primary outcome
Hamilton Depression Rating Scale- 17
Time frame: Baseline
A semi-structured interview focusing on 17 symptoms of depression, range of scores 0-52 with 0 indicating no depression
Hamilton Depression Rating Scale- 17
Time frame: Week 8
A semi-structured interview focusing on 17 symptoms of depressionrange of scores 0-52 with 0 indicating no depression,
Hamilton Depression Rating Scale- 17
Time frame: Week 16
A semi-structured interview focusing on 17 symptoms of depression, range of scores 0-52 with 0 indicating no depression.
3 secondary outcomes
Montgomery Asberg Depression Rating Scale
Time frame: Baseline
Montgomery Asberg Depression Rating Scale
Time frame: Week 8
Montgomery Asberg Depression Rating Scale
Time frame: Week 16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Background: PubMed 25742202Greenberg PE, Fournier AA, Sisitsky T, Pike CT, Kessler RC. The economic burden of adults with major depressive disorder in the United States (2005 and 2010). J Clin Psychiatry. 2015 Feb;76(2):155-62. doi: 10.4088/JCP.14m09298.
- Background: PubMed 12813115Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.
- Background: PubMed 16554525Rush AJ, Trivedi MH, Wisniewski SR, Stewart JW, Nierenberg AA, Thase ME, Ritz L, Biggs MM, Warden D, Luther JF, Shores-Wilson K, Niederehe G, Fava M; STAR*D Study Team. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. N Engl J Med. 2006 Mar 23;354(12):1231-42. doi: 10.1056/NEJMoa052963.
- Background: PubMed 26711860Linge R, Jimenez-Sanchez L, Campa L, Pilar-Cuellar F, Vidal R, Pazos A, Adell A, Diaz A. Cannabidiol induces rapid-acting antidepressant-like effects and enhances cortical 5-HT/glutamate neurotransmission: role of 5-HT1A receptors. Neuropharmacology. 2016 Apr;103:16-26. doi: 10.1016/j.neuropharm.2015.12.017. Epub 2015 Dec 19.
- Background: PubMed 31039391Silote GP, Sartim A, Sales A, Eskelund A, Guimaraes FS, Wegener G, Joca S. Emerging evidence for the antidepressant effect of cannabidiol and the underlying molecular mechanisms. J Chem Neuroanat. 2019 Jul;98:104-116. doi: 10.1016/j.jchemneu.2019.04.006. Epub 2019 Apr 27.
- Background: PubMed 32455953Gall Z, Farkas S, Albert A, Ferencz E, Vancea S, Urkon M, Kolcsar M. Effects of Chronic Cannabidiol Treatment in the Rat Chronic Unpredictable Mild Stress Model of Depression. Biomolecules. 2020 May 22;10(5):801. doi: 10.3390/biom10050801.
- Background: PubMed 30571957Shbiro L, Hen-Shoval D, Hazut N, Rapps K, Dar S, Zalsman G, Mechoulam R, Weller A, Shoval G. Effects of cannabidiol in males and females in two different rat models of depression. Physiol Behav. 2019 Mar 15;201:59-63. doi: 10.1016/j.physbeh.2018.12.019. Epub 2018 Dec 17.
- Background: PubMed 29869197Sales AJ, Fogaca MV, Sartim AG, Pereira VS, Wegener G, Guimaraes FS, Joca SRL. Cannabidiol Induces Rapid and Sustained Antidepressant-Like Effects Through Increased BDNF Signaling and Synaptogenesis in the Prefrontal Cortex. Mol Neurobiol. 2019 Feb;56(2):1070-1081. doi: 10.1007/s12035-018-1143-4. Epub 2018 Jun 4.
- Background: PubMed 29656267Cuttler C, Spradlin A, McLaughlin RJ. A naturalistic examination of the perceived effects of cannabis on negative affect. J Affect Disord. 2018 Aug 1;235:198-205. doi: 10.1016/j.jad.2018.04.054. Epub 2018 Apr 6.
- Background: PubMed 29241357McGuire P, Robson P, Cubala WJ, Vasile D, Morrison PD, Barron R, Taylor A, Wright S. Cannabidiol (CBD) as an Adjunctive Therapy in Schizophrenia: A Multicenter Randomized Controlled Trial. Am J Psychiatry. 2018 Mar 1;175(3):225-231. doi: 10.1176/appi.ajp.2017.17030325. Epub 2017 Dec 15.
- Individual participant dataSharing planned: Yes. Plan to share protocol, consent, SAP,and CRS. Do not plan to share IPD,
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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.
Matthew Macaluso, D.O. principal investigator
University ot Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Active study drug ( oral CBD) in people with Treatment Resistant Depression, run by University of Alabama at Birmingham 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 7 inclusion and 13 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: withdrawn, as of the sponsor's last update on 19 Jul 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Hamilton Depression Rating Scale- 17 (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT04732169, which also lists 10 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 19 Jul 2021.