Bipolar DisorderPhase 2/3CBDBDNCT03310593
Cannabidiol as an Adjunctive Treatment for Bipolar Depression
A Phase 2/3 study testing Cannabidiol in people with Bipolar Disorder and Bipolar Depression, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Depressive symptoms are associated with significant psychosocial impairment. However, current treatments of bipolar depression are only partially effective. Cannabidiol is a natural component of cannabis without psychotomimetic or addictive properties. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar Disorder, Bipolar Depression, Bipolar Affective Disorder
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2017to 24 Mar 2020
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depressive episode as part of bipolar I disorder or bipolar II disorder according to Fifth Edition of Diagnostic and Statistical Manual for Mental Disorders (DSM-5) and are able to provide written informed consent.
- Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 12 and MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness) scores ≥ 2 at baseline.
- Young Mania Rating Scale (YMRS) ≤ 11.
- Currently prescribed lithium or valproic acid and derivates (divalproex sodium, sodium valproate) or atypical antipsychotics at therapeutic dosage for at least 04 weeks before the baseline.
- Females must test negative for pregnancy and must be using adequate birth control measures throughout the study.
Who cannot join
- Another concurrent mental or behavioral disorder that requires psychiatric attention in the past 6 months.
- Young Mania Rating Scale (YMRS) score > 12.
- Current or past drug sensitivity/intolerance to cannabidiol.
- Substance Use Disorder according to DSM-5 within past 6 months, except for nicotine Substance Use Disorder.
- Clinically significant unstable medical illness, neurological disorders or inflammatory/autoimmune diseases.
- Any autoimmune, inflammatory or neurologic disorders that requires treatment with steroidal anti-inflammatory medications or immunotherapy with biologic drugs.
- Actively suicidal or homicidal risk.
- Females who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Clinical Trial of Adjunctive Cannabidiol for Bipolar Depression
Depressive symptoms are associated with significant psychosocial impairment. However, current treatments of bipolar depression are only partially effective.
Cannabidiol is a natural component of cannabis without psychotomimetic or addictive properties. Cannabidiol has been shown to produce therapeutic effects including anticonvulsive, anxiolytic, antipsychotic and neuroprotective effects. The investigators hypothesize that treatment with cannabidiol will result in improvement of depressive and anxiety symptoms, as well as, improvement in functioning and inflammatory biomarkers. During the clinical trial, subjects will receive study medication (cannabidiol 150-300mg/day) or placebo for a period of 12 weeks.
- Being tested
- Cannabidiol, Placebo
- Keywords
- bipolar disorder, bipolar depression, cannabidiol, endocannabinoids
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Cannabidiol as active intervention.
PlaceboDrug
Placebo intervention.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol | Experimental | Cannabidiol 150-300mg per day for 12 weeks. Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | Cannabidiol comparator for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores.
- Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores.
- Scale range: from 0 to 60.
- Higher values represent more severe symptoms of depression.
Measured: 08 weeks
Secondary outcomes (13)
Improvement in clinical global impression.
- Change from baseline in Clinical Global Impression(CGI-BP) scores.
- Scale range: from 1 to 7.
- Higher values represent more severe symptoms of bipolar disorder.
Measured: Up to weeks 08 and 12
Improvement in anxiety symptoms
- Change from baseline in Hamilton Anxiety Rating Scale (HAMA).
- Scale range: from 0 to 56.
- Higher values represent more severe symptoms of anxiety.
Measured: Up to weeks 08 and 12
Improvement in functioning.
- Change from baseline Functioning Assessment Short Test (FAST) scores.
- Scale range: from 0 to 72.
- Higher values represent more severe functional impairment.
Measured: Up to weeks 08 and 12
Improvement in biological rhythms.
- Improvement in biological rhythms according to Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN).
- Scale range: from 0 to 88.
- Higher values represent more severe symptoms of biological rhythms.
Measured: Up to weeks 08 and 12
Change in BDNF levels in the blood.
Change in brain-derived neurotrophic factor (BDNF) levels in the blood.
Measured: Up to weeks 08 and 12
Change in inflammatory levels in the blood.
Change in inflammatory levels in the blood (cytokines, chemokines and C-reactive protein).
Measured: Up to weeks 08 and 12
Change in endocannabinoid levels in the blood.
Change in endocannabinoid levels in the blood (anandamide and 2-arachidonoylglycerol).
Measured: Up to weeks 08 and 12
Remission of manic symptoms.
- Change from baseline in the Young Mania Rating Scale (YMRS) score.
- Scale range: from 0 to 58.
- Higher values represent more severe symptoms of mania.
Measured: Up to weeks 08 and 12
Change in depressive symptoms
- Change from baseline in Hamilton Depression Rating Scale (HAMD) score.
- Scale range: from 0 to 52.
- Higher values represent more severe symptoms of depression.
Measured: Up to weeks 08 and 12
Change in psychotic symptoms
- Change from baseline in Brief Psychiatric Rating Scale (BPRS) score.
- Scale range: from 0 to 108.
- Higher values represent more severe symptoms of psychosis.
Measured: Up to weeks 08 and 12
Change in depressive symptoms according to MADRS
- Higher values represent more severe symptoms of depression.
- Scale range: from 0 to 60.
Measured: Up to week 12
Change in depressive symptoms according to PHQ-9
- Change from baseline in Patient Health Questionnaire (PHQ-9) score.
- Scale range: from 0 to 27.
Measured: Up to weeks 08 and 12
Change in oxidative stress markers levels in the blood.
Change in oxidative stress markers levels in the blood.
Measured: Up to weeks 08 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 Nov 2017
- Primary completion24 Feb 2020
- Study completion24 Mar 2020
Why it stopped: It was interrupted due to the coronavirus pandemic outbreak.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized and placebo controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, University of Sao Paulo
- Responsible party
- Sponsor
- Investigators
- Márcia Kauer-Sant'Anna, MD, PhD, Study chair, Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310593
- Sponsor's protocol ID
- 63811317300005327
- Acronym
- CBDBD
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2017
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pinto JV, Crippa JAS, Cereser KM, Vianna-Sulzbach MF, Silveira Junior EM, Santana da Rosa G, Testa da Silva MG, Hizo GH, Simao Medeiros L, Santana de Oliveira CE, Bristot G, Campos AC, Guimaraes FS, Hallak JEC, Zuardi AW, Yatham LN, Kapczinski F, Kauer-Sant'Anna M. Cannabidiol as an Adjunctive Treatment for Acute Bipolar Depression: A Pilot Study: Le cannabidiol comme traitement d'appoint de la depression bipolaire aigue : une etude pilote. Can J Psychiatry. 2024 Apr;69(4):242-251. doi: 10.1177/07067437231209650. Epub 2023 Nov 3.
PubMed 37920963
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Clinical Trial of Adjunctive Cannabidiol for Bipolar Depression
- ClinicalTrials.gov ID
- NCT03310593
- Acronym / sponsor ID
- CBDBD / 63811317300005327
- Keywords
- bipolar disorder, bipolar depression, cannabidiol, endocannabinoids
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was interrupted due to the coronavirus pandemic outbreak.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, University of Sao Paulo
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 16 Oct 2017 (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.
Depressive symptoms are associated with significant psychosocial impairment. However, current treatments of bipolar depression are only partially effective.
Cannabidiol is a natural component of cannabis without psychotomimetic or addictive properties. Cannabidiol has been shown to produce therapeutic effects including anticonvulsive, anxiolytic, antipsychotic and neuroprotective effects. The investigators hypothesize that treatment with cannabidiol will result in improvement of depressive and anxiety symptoms, as well as, improvement in functioning and inflammatory biomarkers. During the clinical trial, subjects will receive study medication (cannabidiol 150-300mg/day) or placebo for a period of 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized and placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol | Experimental | Drug: CannabidiolCannabidiol 150-300mg per day for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboCannabidiol comparator for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major depressive episode as part of bipolar I disorder or bipolar II disorder according to Fifth Edition of Diagnostic and Statistical Manual for Mental Disorders (DSM-5) and are able to provide written informed consent.
- Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 12 and MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness) scores ≥ 2 at baseline.
- Young Mania Rating Scale (YMRS) ≤ 11.
- Currently prescribed lithium or valproic acid and derivates (divalproex sodium, sodium valproate) or atypical antipsychotics at therapeutic dosage for at least 04 weeks before the baseline.
- Females must test negative for pregnancy and must be using adequate birth control measures throughout the study.
Key exclusion criteria (8 listed)
- Another concurrent mental or behavioral disorder that requires psychiatric attention in the past 6 months.
- Young Mania Rating Scale (YMRS) score > 12.
- Current or past drug sensitivity/intolerance to cannabidiol.
- Substance Use Disorder according to DSM-5 within past 6 months, except for nicotine Substance Use Disorder.
- Clinically significant unstable medical illness, neurological disorders or inflammatory/autoimmune diseases.
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 |
|---|---|---|
| CannabidiolCannabidiol as active intervention. | Drug | Cannabidiol |
| PlaceboPlacebo intervention. | Drug | Placebo |
Primary outcome
Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores.
Time frame: 08 weeks
* Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores. * Scale range: from 0 to 60. * Higher values represent more severe symptoms of depression.
13 secondary outcomes
Improvement in clinical global impression.
Time frame: Up to weeks 08 and 12
Improvement in anxiety symptoms
Time frame: Up to weeks 08 and 12
Improvement in functioning.
Time frame: Up to weeks 08 and 12
Improvement in biological rhythms.
Time frame: Up to weeks 08 and 12
Change in BDNF levels in the blood.
Time frame: Up to weeks 08 and 12
Change in inflammatory levels in the blood.
Time frame: Up to weeks 08 and 12
Change in endocannabinoid levels in the blood.
Time frame: Up to weeks 08 and 12
Remission of manic symptoms.
Time frame: Up to weeks 08 and 12
Change in depressive symptoms
Time frame: Up to weeks 08 and 12
Change in psychotic symptoms
Time frame: Up to weeks 08 and 12
Change in depressive symptoms according to MADRS
Time frame: Up to week 12
Change in depressive symptoms according to PHQ-9
Time frame: Up to weeks 08 and 12
Change in oxidative stress markers levels in the blood.
Time frame: Up to weeks 08 and 12
Results and safety
The study was stopped early (reason given: It was interrupted due to the coronavirus pandemic outbreak.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Derived from this study: PubMed 37920963Pinto JV, Crippa JAS, Cereser KM, Vianna-Sulzbach MF, Silveira Junior EM, Santana da Rosa G, Testa da Silva MG, Hizo GH, Simao Medeiros L, Santana de Oliveira CE, Bristot G, Campos AC, Guimaraes FS, Hallak JEC, Zuardi AW, Yatham LN, Kapczinski F, Kauer-Sant'Anna M. Cannabidiol as an Adjunctive Treatment for Acute Bipolar Depression: A Pilot Study: Le cannabidiol comme traitement d'appoint de la depression bipolaire aigue : une etude pilote. Can J Psychiatry. 2024 Apr;69(4):242-251. doi: 10.1177/07067437231209650. Epub 2023 Nov 3.
- Individual participant dataSharing planned: No
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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.
Márcia Kauer-Sant'Anna, MD, PhD study chair
Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cannabidiol in people with Bipolar Disorder and Bipolar Depression, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 8 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: stopped early, as of the sponsor's last update on 2 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 Brazil. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: It was interrupted due to the coronavirus pandemic outbreak.). Results are not available in the source record.
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?
Change from baseline Montgomery-Asberg Depression Rating Scale (MADRS) scores. (time frame: 08 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 NCT03310593, which also lists 1 linked publication.
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 2 Jul 2021.