Depression, BipolarPhase 2NCT02625779
Combined Cytidine and Creatine-containing Drug in the Treatment of the Bipolar Depression
A Phase 2 study testing Valproate and Cytidine-containing Drug and Valproate and Creatine-containing Drug in people with Depression, Bipolar, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
Trial summary
This research is aimed to investigate the efficacy and safety of the creatine and cytidine augmentation in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using proton and phosphorous magnetic resonance spectroscopy. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Depression, Bipolar
- What is being tested?
- Valproate and Cytidine-containing Drug and Valproate and Creatine-containing Drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2016to 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
- Aged 19-65 years
- Bipolar disorder I or II (DSM-IV-TR) with current depressive episode
- Informed consent
Who cannot join
- Use of medication for bipolar depression or other psychotropic drugs
- Current Axis I mental disorders other than bipolar depression based on structured clinical interview
- Current borderline or antisocial personality disorder based on structured clinical interview
- Major medical or neurological illnesses (epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc)
- Hypersensitivity to divalproate or valpromide
- Diagnosis of porphyria
Show all 14Show fewer
- Current or past liver diseases
- Severe dysfunction in liver or pancreas
- Use of mefloquine
- Alcohol or substance abuse/dependence
- Intelligence quotient of 80 or below
- Contraindications to magnetic resonance imaging
- Pregnancy or breastfeeding
- 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 research is aimed to investigate the efficacy and safety of the creatine and cytidine augmentation in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using proton and phosphorous magnetic resonance spectroscopy.
- Conditions
- Depression, Bipolar
- Being tested
- Valproate and Placebo, Valproate and Cytidine-containing Drug, Valproate and Creatine-containing Drug
- Keywords
- Bipolar depression, Cytidine, Creatine, Magnetic resonance spectroscopy
- 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 and PlaceboDrug
Valproate and Cytidine-containing DrugDrug
Valproate and Creatine-containing DrugDrug
| Study group | Role | What they receive |
|---|---|---|
| Valproate and Placebo | Active comparator | Valproate: 300mg/day for 8 weeks Placebo: for 8 weeks Receives: Drug: Valproate and Placebo |
| Valproate and Cytidine-containing Drug | Experimental | Valproate: 300mg/day for 8 weeks Cytidine-containing Drug: 2g/day for 8 weeks Receives: Drug: Valproate and Cytidine-containing Drug |
| Valproate and Creatine-containing Drug | Experimental | Valproate: 300mg/day for 8 weeks Creatine-containing Drug: 3g/day for the first week 5g/day for week 2-8 Receives: Drug: Valproate and Creatine-containing Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms of bipolar depression
assessed with structured clinical interview
Measured: Baseline and 8 weeks
Change in depressive symptoms
assessed with structured clinical interview
Measured: Baseline and 8 weeks
Secondary outcomes (3)
Change in brain Glx (glutamate+glutamine) level
assessed with proton magnetic resonance spectroscopy
Measured: Baseline and 8 weeks
Change in brain phosphocreatine level
assessed with phosphorous magnetic resonance spectroscopy
Measured: Baseline and 8 weeks
Number of participants with adverse events
Measured: Baseline through 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study start1 Mar 2016 (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 Depression, BipolarStudies 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 Mokdong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Kyoon Lyoo, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625779
- Sponsor's protocol ID
- NARSAD_Bipolar
- Status last verified
- Feb 2018
- First submitted
- 7 Dec 2015
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
- NCT02625779
- Acronym / sponsor ID
- NARSAD_Bipolar
- Conditions
- Depression, Bipolar
- Keywords
- Bipolar depression, Cytidine, Creatine, Magnetic resonance spectroscopy
- 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 University Mokdong HospitalUniversity, hospital or other
- Study start
- 1 Mar 2016 (estimated)
- Primary completion
- 30 Apr 2017 (estimated)
- Study completion
- 30 Apr 2017 (estimated)
- First posted
- 9 Dec 2015 (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 research is aimed to investigate the efficacy and safety of the creatine and cytidine augmentation in treating bipolar depression and to evaluate changes in relevant brain biochemical metabolism using proton and phosphorous 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 and Placebo | Active comparator | Drug: Valproate and PlaceboValproate: 300mg/day for 8 weeks Placebo: for 8 weeks |
| Valproate and Cytidine-containing Drug | Experimental | Drug: Valproate and Cytidine-containing DrugValproate: 300mg/day for 8 weeks Cytidine-containing Drug: 2g/day for 8 weeks |
| Valproate and Creatine-containing Drug | Experimental | Drug: Valproate and Creatine-containing DrugValproate: 300mg/day for 8 weeks Creatine-containing Drug: 3g/day for the first week 5g/day for week 2-8 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 19-65 years
- Bipolar disorder I or II (DSM-IV-TR) with current depressive episode
- Informed consent
Key exclusion criteria (14 listed)
- Use of medication for bipolar depression or other psychotropic drugs
- Current Axis I mental disorders other than bipolar depression based on structured clinical interview
- Current borderline or antisocial personality disorder based on structured clinical interview
- Major medical or neurological illnesses (epilepsy, multiple sclerosis, brain tumor, cerebrovascular disease, etc)
- Hypersensitivity to divalproate or valpromide
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 and Placebo | Drug | Valproate and Placebo |
| Valproate and Cytidine-containing Drug | Drug | Valproate and Cytidine-containing Drug |
| Valproate and Creatine-containing Drug | Drug | Valproate and Creatine-containing Drug |
Primary outcome
Change in symptoms of bipolar depression
Time frame: Baseline and 8 weeks
assessed with structured clinical interview
Change in depressive symptoms
Time frame: Baseline and 8 weeks
assessed with structured clinical interview
3 secondary outcomes
Change in brain Glx (glutamate+glutamine) level
Time frame: Baseline and 8 weeks
Change in brain phosphocreatine level
Time frame: Baseline and 8 weeks
Number of participants with adverse events
Time frame: Baseline through 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Cytidine-containing Drug and Valproate and Creatine-containing Drug in people with Depression, Bipolar, run by Ewha Womans University Mokdong Hospital 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 14 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 in symptoms of bipolar depression (time frame: Baseline and 8 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.