Bipolar Disorder IIPhase 3NCT03039842
Combination of Dextromethorphan and Memantine in Treating Bipolar Disorder
A Phase 3 study testing Dextromethorphan, Memantine and dextromethorphan+memantine in people with Bipolar Disorder II, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
This is a research clinical trial of double-blind, stratified randomized, parallel group, two-centre study. It will be conducted in a total of 250~300 male and female subjects from the Department of Psychiatry at National Cheng Kung University Hospital. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder II
- What is being tested?
- Dextromethorphan, Memantine and dextromethorphan+memantine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2013to 31 Dec 2017
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A 2-day minimum for hypomania to diagnose bipolar II disorder
- A total of Hamilton Rating Scale for Depression scored at least 18 or Young Mania Rating Scale scored at least 14 at the screening stage
- Must allow to ensure acceptable compliance and visit
Who cannot join
- Pregnant females or nursing
- Women of childbearing potential not using adequate contraception
- Received dextromethorphan, memantine, other antiinflammatory medication within 1 week prior
- Clinically significant medical condition (cardiac, hepatic and renal disease)
- Received electroconvulsive therapy patients within 4 weeks prior to the first dose of double-blind medication
- Increase in total SGOT, SGPT, BUN and creatinine by more than 3X upper limit of normal.
Trial locations and contacts
1 site in 1 country.
About this study
This is a research clinical trial of double-blind, stratified randomized, parallel group, two-centre study. It will be conducted in a total of 250~300 male and female subjects from the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects will be psychiatric out- and in-patients, aged between 18~65 years old, who have psychiatric evaluation with clinically suspected of having bipolar II disorder and fulfill the inclusion and exclusion criteria. The add-on double-blind study treatment with dextromethorphan/place will commence at randomization for while patients continue open-label valproate. Subjects will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg dextromethorphan+valproate, (2) 5mg memantine+valproate, (3) dextromethorphan+memantine+valproate or (4) placebo+valproate. Concomitant benzodiazepine medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or insomnia during the study. For the consideration of the less influence to immune-system, resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. We will measure the treatment response and side effect to clarify the curative effect of DM and memantine add-on therapy to valproate in the treatment of bipolar disorders. This study is being performed to investigate the possibly significant beneficial effects on the subtypes of bipolar disorders psychopathology.
Read the detailed description
A total of 250~300 male and female subjects from the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects who are aged between 18~65 years old and clinically suspected of having bipolar II disorder are invited. The add-on double-blind study treatment with dextromethorphan/place will commence at randomization for while patients continue open-label valproate. Subjects will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg dextromethorphan+valproate, (2) 5mg memantine+valproate, (3) dextromethorphan+memantine+valproate or (4) placebo+valproate. Concomitant benzodiazepine medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or insomnia during the study. For the consideration of the less influence to immune-system, resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. We will measure the treatment response and side effect to clarify the curative effect of DM and memantine add-on therapy to valproate in the treatment of bipolar disorders. This study is being performed to investigate the possibly significant beneficial effects on the subtypes of bipolar disorders psychopathology.
- Conditions
- Bipolar Disorder II
- Being tested
- Dextromethorphan, Memantine, dextromethorphan+memantine, placebo+valproate
- Keywords
- dextromethorphan; memantine; treatment response
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextromethorphanDrug
Also called 30mg dextromethorphan
MemantineDrug
Also called 5mg memantine+valproate
dextromethorphan+memantineDrug
placebo+valproateDrug
| Study group | Role | What they receive |
|---|---|---|
| 30 mg DM | Experimental | 30mg dextromethorphan+valproate Receives: Drug: Dextromethorphan |
| 5 mg MM | Experimental | 5mg memantine+valproate Receives: Drug: Memantine |
| DM+MM | Experimental | dextromethorphan+memantine+ valproate Receives: Drug: dextromethorphan+memantine |
| placebo | Placebo comparator | Placebo+valproate Receives: Drug: placebo+valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment change assessed by plasma levels of cytokines (e.g., IL-6, IL-8)
change assessment
Measured: baseline, week 1, week 2, week 4, week 8, week 12
Secondary outcomes (2)
depression change change
depression change assessed by Hamilton Depression Rating Scale
Measured: baseline, week 1, week 2, week 4, week 8, week 12
manic state change
Manic symptom assessed by Young Mania Rating Scale
Measured: baseline, week 1, week 2, week 4, week 8, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Jan 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2017 (estimated)
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 Disorder IIStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Band Lu, National Cheng-Kung University Hospital
- Investigators
- Ru-Band Lu, MD, Principal investigator, Department of Psychiatry, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039842
- Sponsor's protocol ID
- CombindBP2014
- Status last verified
- Jul 2017
- First submitted
- 29 Aug 2014
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SY, Wang TY, Chen SL, Chang YH, Chen PS, Huang SY, Tzeng NS, Wang LJ, Lee IH, Chen KC, Yang YK, Hong JS, Lu RB. Combination of dextromethorphan and memantine in treating bipolar spectrum disorder: a 12-week double-blind randomized clinical trial. Int J Bipolar Disord. 2020 Mar 2;8(1):11. doi: 10.1186/s40345-019-0174-8.
PubMed 32115672
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Dextromethorphan and Memantine in Treating Bipolar Disorder
- ClinicalTrials.gov ID
- NCT03039842
- Acronym / sponsor ID
- CombindBP2014
- Conditions
- Bipolar Disorder II
- Keywords
- dextromethorphan; memantine; treatment response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 1 Feb 2017 (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 is a research clinical trial of double-blind, stratified randomized, parallel group, two-centre study. It will be conducted in a total of 250~300 male and female subjects from the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects will be psychiatric out- and in-patients, aged between 18~65 years old, who have psychiatric evaluation with clinically suspected of having bipolar II disorder and fulfill the inclusion and exclusion criteria. The add-on double-blind study treatment with dextromethorphan/place will commence at randomization for while patients continue open-label valproate. Subjects will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg dextromethorphan+valproate, (2) 5mg memantine+valproate, (3) dextromethorphan+memantine+valproate or (4) placebo+valproate. Concomitant benzodiazepine medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or insomnia during the study. For the consideration of the less influence to immune-system, resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. We will measure the treatment response and side effect to clarify the curative effect of DM and memantine add-on therapy to valproate in the treatment of bipolar disorders. This study is being performed to investigate the possibly significant beneficial effects on the subtypes of bipolar disorders psychopathology.
Detailed description
A total of 250~300 male and female subjects from the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects who are aged between 18~65 years old and clinically suspected of having bipolar II disorder are invited. The add-on double-blind study treatment with dextromethorphan/place will commence at randomization for while patients continue open-label valproate. Subjects will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg dextromethorphan+valproate, (2) 5mg memantine+valproate, (3) dextromethorphan+memantine+valproate or (4) placebo+valproate. Concomitant benzodiazepine medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or insomnia during the study. For the consideration of the less influence to immune-system, resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. We will measure the treatment response and side effect to clarify the curative effect of DM and memantine add-on therapy to valproate in the treatment of bipolar disorders. This study is being performed to investigate the possibly significant beneficial effects on the subtypes of bipolar disorders psychopathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 30 mg DM | Experimental | Drug: Dextromethorphan30mg dextromethorphan+valproate |
| 5 mg MM | Experimental | Drug: Memantine5mg memantine+valproate |
| DM+MM | Experimental | Drug: dextromethorphan+memantinedextromethorphan+memantine+ valproate |
| placebo | Placebo comparator | Drug: placebo+valproatePlacebo+valproate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A 2-day minimum for hypomania to diagnose bipolar II disorder
- A total of Hamilton Rating Scale for Depression scored at least 18 or Young Mania Rating Scale scored at least 14 at the screening stage
- Must allow to ensure acceptable compliance and visit
Key exclusion criteria (6 listed)
- Pregnant females or nursing
- Women of childbearing potential not using adequate contraception
- Received dextromethorphan, memantine, other antiinflammatory medication within 1 week prior
- Clinically significant medical condition (cardiac, hepatic and renal disease)
- Received electroconvulsive therapy patients within 4 weeks prior to the first dose of double-blind medication
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 |
|---|---|---|
| DextromethorphanAlso: 30mg dextromethorphan | Drug | 30 mg DM |
| MemantineAlso: 5mg memantine+valproate | Drug | 5 mg MM |
| dextromethorphan+memantine | Drug | DM+MM |
| placebo+valproate | Drug | placebo |
Primary outcome
treatment change assessed by plasma levels of cytokines (e.g., IL-6, IL-8)
Time frame: baseline, week 1, week 2, week 4, week 8, week 12
change assessment
2 secondary outcomes
depression change change
Time frame: baseline, week 1, week 2, week 4, week 8, week 12
manic state change
Time frame: baseline, week 1, week 2, week 4, week 8, week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Derived from this study: PubMed 32115672Lee SY, Wang TY, Chen SL, Chang YH, Chen PS, Huang SY, Tzeng NS, Wang LJ, Lee IH, Chen KC, Yang YK, Hong JS, Lu RB. Combination of dextromethorphan and memantine in treating bipolar spectrum disorder: a 12-week double-blind randomized clinical trial. Int J Bipolar Disord. 2020 Mar 2;8(1):11. doi: 10.1186/s40345-019-0174-8.
- Individual participant dataSharing planned: No
Related trials for Bipolar Disorder II
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
Not yet recruitingPhase 2
N-Acetylcysteine for Bipolar and Alcohol Use Disorders
Bipolar Disorder, Alcohol Use Disorder
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Active, not recruitingPhase 3
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
Bipolar Depression, Bipolar I Disorder
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.
Ru-Band Lu, MD principal investigator
Department of Psychiatry, National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dextromethorphan, Memantine and dextromethorphan+memantine in people with Bipolar Disorder II, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 6 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: status not confirmed, as of the sponsor's last update on 11 Jul 2017. 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 Taiwan. 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 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?
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?
treatment change assessed by plasma levels of cytokines (e.g., IL-6, IL-8) (time frame: baseline, week 1, week 2, week 4, week 8, week 12). 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 NCT03039842, 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 11 Jul 2017.