Bipolar I DisorderNCT01655030
Creatine Monohydrate as Adjuvant Therapy for Bipolar Depression
A study testing creatine monohydrate in people with Bipolar I Disorder and Current Episode Depressed, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether creatine monohydrate is effective as an adjuvant treatment for bipolar depression. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar I Disorder, Current Episode Depressed
- What is being tested?
- creatine monohydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals eligible for the study will be adults aged 18 to 60 years of age who met DSM-IV criteria assessed by the SCID (Structural Clinical Interview for DSM-IV) for type I bipolar disorder, current episode depressed.
- Patients who have scored > 19 on the Montgomery-Asberg Depression Rating Scale (MADRS) will be included, although more than two weeks of treatment with lithium (serum level> 0.8 mEq / L), valproate (serum levels> 50 mg / L) or quetiapine (300-600mg/dia dose) or drug combination.
- Antipsychotics, anticonvulsants, benzodiazepines, and thyroid supplementation will be allowed if the dose has remained stable over the past two weeks.
- Antidepressants will be allowed if the dosage has remained stable for 4 weeks.
Who cannot join
- Subjects with substance abuse within 2 weeks before inclusion or substance dependence up to 2 months will not be included.
- Other exclusion criteria will be:
- diagnosis of schizophrenia,
- dementia,
- delirium,
- epilepsy,
Show all 12Show fewer
- mental retardation,
- clinically unstable medical illnesses,
- preexisting renal disease,
- history of hypersensibility to creatine.
- Not included are individuals at high risk for suicidal or homicidal behavior or self-mutilation will not be included.
- Women with gestational potential can only be included if they are using reliable contraception.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Psychiatry - HC-FMUSP
São Paulo, São Paulo, 01060-970
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Creatine Monohydrate as Adjunctive Therapy for Bipolar Depression
The purpose of this study is to determine whether creatine monohydrate is effective as an adjuvant treatment for bipolar depression.
Read the detailed description
Bipolar Depression is associated with high rates of disability and increased mortality. Despite its major negative impact, treatment of Bipolar Depression is still controversial and only partially efficacious, with over half of patients not responding adequately to available treatment. In this context, the use of drugs that modulate energy metabolism has been proposed as promising new option as treatment strategies for bipolar depression. The aim of our proposed study is to perform a 6-week randomized, double-blind, placebo-controlled clinical trial of creatine monohydrate as an adjuvant treatment for bipolar depression.
- Conditions
- Bipolar I Disorder, Current Episode Depressed
- Being tested
- creatine monohydrate, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creatine monohydrateDietary supplement
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| creatine monohydrate | Experimental | 6g qd for 6 weeks Receives: Dietary Supplement: creatine monohydrate |
| placebo | Placebo comparator | 6g qd for 6 weeks Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS (Montgomery-Asberg Depression Rating Scale)
change of score on the Montgomery-Asberg Depression Rating Scale
Measured: 6 weeks
Secondary outcomes (1)
HDRS-17 (Hamilton Depression Rating Scale - 17-item version)
change of score on the Hamilton Depression Rating Scale - 17-item version
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2016
- Study completionMar 2016
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 I DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Alexandre Toniolo, University of Sao Paulo
- Investigators
- Beny Lafer, PhD, Principal investigator, Bipolar Disorder Research Program, Coordinator, IPq-HC-FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655030
- Sponsor's protocol ID
- CR-BD-RCT
- Status last verified
- Dec 2023
- First submitted
- 29 Jul 2012
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Toniolo RA, Silva M, Fernandes FBF, Amaral JAMS, Dias RDS, Lafer B. A randomized, double-blind, placebo-controlled, proof-of-concept trial of creatine monohydrate as adjunctive treatment for bipolar depression. J Neural Transm (Vienna). 2018 Feb;125(2):247-257. doi: 10.1007/s00702-017-1817-5. Epub 2017 Nov 24.
PubMed 29177955
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Creatine Monohydrate as Adjunctive Therapy for Bipolar Depression
- ClinicalTrials.gov ID
- NCT01655030
- Acronym / sponsor ID
- CR-BD-RCT
- Conditions
- Bipolar I Disorder, Current Episode Depressed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Aug 2012 (estimated)
- 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 purpose of this study is to determine whether creatine monohydrate is effective as an adjuvant treatment for bipolar depression.
Detailed description
Bipolar Depression is associated with high rates of disability and increased mortality. Despite its major negative impact, treatment of Bipolar Depression is still controversial and only partially efficacious, with over half of patients not responding adequately to available treatment. In this context, the use of drugs that modulate energy metabolism has been proposed as promising new option as treatment strategies for bipolar depression. The aim of our proposed study is to perform a 6-week randomized, double-blind, placebo-controlled clinical trial of creatine monohydrate as an adjuvant treatment for bipolar depression.
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 |
|---|---|---|
| creatine monohydrate | Experimental | Dietary Supplement: creatine monohydrate6g qd for 6 weeks |
| placebo | Placebo comparator | Dietary Supplement: placebo6g qd for 6 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals eligible for the study will be adults aged 18 to 60 years of age who met DSM-IV criteria assessed by the SCID (Structural Clinical Interview for DSM-IV) for type I bipolar disorder, current episode depressed.
- Patients who have scored > 19 on the Montgomery-Asberg Depression Rating Scale (MADRS) will be included, although more than two weeks of treatment with lithium (serum level> 0.8 mEq / L), valproate (serum levels> 50 mg / L) or quetiapine (300-600mg/dia dose) or drug combination.
- Antipsychotics, anticonvulsants, benzodiazepines, and thyroid supplementation will be allowed if the dose has remained stable over the past two weeks.
- Antidepressants will be allowed if the dosage has remained stable for 4 weeks.
Key exclusion criteria (12 listed)
- Subjects with substance abuse within 2 weeks before inclusion or substance dependence up to 2 months will not be included.
- Other exclusion criteria will be:
- Not included are individuals at high risk for suicidal or homicidal behavior or self-mutilation will not be included.
- Women with gestational potential can only be included if they are using reliable contraception.
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 |
|---|---|---|
| creatine monohydrate | Dietary supplement | creatine monohydrate |
| placebo | Dietary supplement | placebo |
Primary outcome
MADRS (Montgomery-Asberg Depression Rating Scale)
Time frame: 6 weeks
change of score on the Montgomery-Asberg Depression Rating Scale
1 secondary outcome
HDRS-17 (Hamilton Depression Rating Scale - 17-item version)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Derived from this study: PubMed 29177955Toniolo RA, Silva M, Fernandes FBF, Amaral JAMS, Dias RDS, Lafer B. A randomized, double-blind, placebo-controlled, proof-of-concept trial of creatine monohydrate as adjunctive treatment for bipolar depression. J Neural Transm (Vienna). 2018 Feb;125(2):247-257. doi: 10.1007/s00702-017-1817-5. Epub 2017 Nov 24.
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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.
Beny Lafer, PhD principal investigator
Bipolar Disorder Research Program, Coordinator, IPq-HC-FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing creatine monohydrate in people with Bipolar I Disorder and Current Episode Depressed, run by University of Sao Paulo 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 5 Dec 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (Montgomery-Asberg Depression Rating Scale) (time frame: 6 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 NCT01655030, 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 5 Dec 2023; AzTrials last refreshed its copy on 30 Oct 2026.