Bipolar DepressionPhase 2NCT01543139
Cytidine- and Creatine-Containing Drug in Treating Bipolar Depression
A Phase 2 study testing Valproate+Cytidine-+Creatine-, Valproate+Cytidine- and Valproate in people with Bipolar Depression, run by Ewha Womans University at 1 site in South Korea.
Trial summary
This proposed research is aimed to investigate the efficacy and safety of combined cytidine- and creatine-containing drug and dietary supplement in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using magnetic resonance spectroscopy. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Valproate+Cytidine-+Creatine-, Valproate+Cytidine- and Valproate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2015to 30 Apr 2017
- Phase
- Phase 2
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19-65 year-old male or female
- Bipolar depression diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV)
- Written informed consent
Who cannot join
- Present use of drugs for bipolar depression or any psychotropic medication
- Use of psychoactive medication that may affect brain imaging findings
- Diagnosis of any other axis I psychiatric disorder
- Presence of borderline personality disorder or antisocial personality disorder
- Presence of any major physical or neurological illness (e.g., epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc.)
- Hypersensitivity to divalproate, valpromide or diagnosis of porphyria
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- Past or current liver disease, current severe liver or pancreas dysfunction
- Currently taking mefloquine
- Presence of alcohol or drug dependence, drug abuse
- Intelligence quotient below 80
- Contraindications to magnetic resonance imaging
- Women who are pregnant, breastfeeding, or planning pregnancy
- Allergy or intolerance to the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled Trial of Combined Cytidine- and Creatine-Containing Drug and Dietary Supplement in the Treatment of the Bipolar Depression
This proposed research is aimed to investigate the efficacy and safety of combined cytidine- and creatine-containing drug and dietary supplement in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using magnetic resonance spectroscopy.
- Conditions
- Bipolar Depression
- Being tested
- Valproate+Cytidine-+Creatine-, Valproate+Cytidine-, Valproate
- Keywords
- Bipolar Depression, Magnetic resonance spectroscopy, Cytidine-, Creatine-
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproate+Cytidine-+Creatine-Drug
Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day, Creatine-: Week0-1: 3g/day Week1-8: 5g/day
Valproate+Cytidine-Drug
Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day
ValproateDrug
Valproate: Week0-8: 300mg/day
| Study group | Role | What they receive |
|---|---|---|
| Valproate+Cytidine-+Creatine- | Experimental | The subjects with bipolar depression, treated with cytidine- and creatine-containing drug and dietary supplement in addition to valproate Receives: Drug: Valproate+Cytidine-+Creatine- |
| Valproate+Cytidine- | Active comparator | The subjects with bipolar depression, treated with cytidine-containing drug and dietary supplement in addition to valproate Receives: Drug: Valproate+Cytidine- |
| Valproate | Active comparator | The subjects with bipolar depression, treated with valproate Receives: Drug: Valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in depressive symptom scores at 4 weeks
Measured: Baseline and at 4 weeks
Change from baseline in depressive symptom scores at 8 weeks
Measured: Baseline and at 8 weeks
Secondary outcomes (4)
Changes in brain Glx (glutamate+glutamine) level assessed using magnetic resonance spectroscopy at baseline and 8 weeks
Measured: Baseline and at 8 weeks
Number of participants with adverse events
Measured: 4 weeks
Number of participants with adverse events
Measured: 8 weeks
Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks
Measured: Baseline and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study start1 Dec 2015 (estimated)
- Primary completion30 Apr 2017 (estimated)
- Study completion30 Apr 2017 (estimated)
Why it stopped: The research project has been cancelled before any participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Kyoon Lyoo, Ewha Womans University
- Investigators
- In Kyoon Lyoo, MD, PhD, MMS, Principal investigator, Ewha Womans University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543139
- Sponsor's protocol ID
- EBI_bipolar2015
- Status last verified
- Feb 2018
- First submitted
- 27 Feb 2012
- Last updated
- 9 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Trial of Combined Cytidine- and Creatine-Containing Drug and Dietary Supplement in the Treatment of the Bipolar Depression
- ClinicalTrials.gov ID
- NCT01543139
- Acronym / sponsor ID
- EBI_bipolar2015
- Conditions
- Bipolar Depression
- Keywords
- Bipolar Depression, Magnetic resonance spectroscopy, Cytidine-, Creatine-
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The research project has been cancelled before any participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- 1 Dec 2015 (estimated)
- Primary completion
- 30 Apr 2017 (estimated)
- Study completion
- 30 Apr 2017 (estimated)
- First posted
- 2 Mar 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.
This proposed research is aimed to investigate the efficacy and safety of combined cytidine- and creatine-containing drug and dietary supplement in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using magnetic resonance spectroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Valproate+Cytidine-+Creatine- | Experimental | Drug: Valproate+Cytidine-+Creatine-The subjects with bipolar depression, treated with cytidine- and creatine-containing drug and dietary supplement in addition to valproate |
| Valproate+Cytidine- | Active comparator | Drug: Valproate+Cytidine-The subjects with bipolar depression, treated with cytidine-containing drug and dietary supplement in addition to valproate |
| Valproate | Active comparator | Drug: ValproateThe subjects with bipolar depression, treated with valproate |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19-65 year-old male or female
- Bipolar depression diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV)
- Written informed consent
Key exclusion criteria (13 listed)
- Present use of drugs for bipolar depression or any psychotropic medication
- Use of psychoactive medication that may affect brain imaging findings
- Diagnosis of any other axis I psychiatric disorder
- Presence of borderline personality disorder or antisocial personality disorder
- Presence of any major physical or neurological illness (e.g., epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc.)
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 |
|---|---|---|
| Valproate+Cytidine-+Creatine-Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day, Creatine-: Week0-1: 3g/day Week1-8: 5g/day | Drug | Valproate+Cytidine-+Creatine- |
| Valproate+Cytidine-Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day | Drug | Valproate+Cytidine- |
| ValproateValproate: Week0-8: 300mg/day | Drug | Valproate |
Primary outcome
Change from baseline in depressive symptom scores at 4 weeks
Time frame: Baseline and at 4 weeks
Change from baseline in depressive symptom scores at 8 weeks
Time frame: Baseline and at 8 weeks
4 secondary outcomes
Changes in brain Glx (glutamate+glutamine) level assessed using magnetic resonance spectroscopy at baseline and 8 weeks
Time frame: Baseline and at 8 weeks
Number of participants with adverse events
Time frame: 4 weeks
Number of participants with adverse events
Time frame: 8 weeks
Changes in brain phosphocreatine level assessed using magnetic resonance spectroscopy at baseline and 8 weeks
Time frame: Baseline and at 8 weeks
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 9 Feb 2018.
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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.
In Kyoon Lyoo, MD, PhD, MMS principal investigator
Ewha Womans University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valproate+Cytidine-+Creatine-, Valproate+Cytidine- and Valproate in people with Bipolar Depression, run by Ewha Womans University at 1 site in South Korea.
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 3 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 9 Feb 2018. 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 South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Change from baseline in depressive symptom scores at 4 weeks (time frame: Baseline and at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.