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Combination of Dextromethorphan and Memantine in Treating Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT03039842
Recruitment Status : Unknown
Verified July 2017 by Ru-Band Lu, National Cheng-Kung University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : February 1, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Ru-Band Lu, National Cheng-Kung University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder II Drug: Dextromethorphan Drug: Memantine Drug: dextromethorphan+memantine Drug: placebo+valproate Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Combination of Dextromethorphan and Memantine in Treating Bipolar Disorder
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : December 31, 2016
Estimated Study Completion Date : December 31, 2017


Arm Intervention/treatment
Experimental: 30 mg DM
30mg dextromethorphan+valproate
Drug: Dextromethorphan
Other Name: 30mg dextromethorphan

Experimental: 5 mg MM
5mg memantine+valproate
Drug: Memantine
Other Name: 5mg memantine+valproate

Experimental: DM+MM
dextromethorphan+memantine+ valproate
Drug: dextromethorphan+memantine
Placebo Comparator: placebo
Placebo+valproate
Drug: placebo+valproate



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. depression change change [ Time Frame: baseline, week 1, week 2, week 4, week 8, week 12 ]
    depression change assessed by Hamilton Depression Rating Scale

  2. manic state change [ Time Frame: baseline, week 1, week 2, week 4, week 8, week 12 ]
    Manic symptom assessed by Young Mania Rating Scale


Other Outcome Measures:
  1. attention function change [ Time Frame: baseline, week 12 ]
    attention change assessed by CPT

  2. memory change [ Time Frame: baseline, week 12 ]
    memory change assessed by WMS

  3. executive functioning change [ Time Frame: baseline, week 12 ]
    executive function change assessed by WCST



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039842


Locations
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Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
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Principal Investigator: Ru-Band Lu, MD Department of Psychiatry, National Cheng Kung University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ru-Band Lu, Distinguished Professor, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT03039842    
Other Study ID Numbers: CombindBP2014
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ru-Band Lu, National Cheng-Kung University Hospital:
dextromethorphan; memantine; treatment response
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Memantine
Dextromethorphan
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antitussive Agents
Respiratory System Agents
Anticonvulsants
Enzyme Inhibitors
GABA Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs