Combination of Dextromethorphan and Memantine in Treating Bipolar Disorder

Bipolar Disorder II Clinical Trial

Official title:

Combination of Dextromethorphan and Memantine in Treating Bipolar Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03039842
• Other study ID #: CombindBP2014
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: August 29, 2014
• Last updated: July 6, 2017
• Start date: January 1, 2013
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2017
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder II
• Disease

Intervention

Drug:
• Dextromethorphan

• Memantine

• dextromethorphan+memantine

• placebo+valproate

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	attention function change	attention change assessed by CPT	baseline, week 12
Other	memory change	memory change assessed by WMS	baseline, week 12
Other	executive functioning change	executive function change assessed by WCST	baseline, week 12
Primary	treatment change assessed by plasma levels of cytokines (e.g., IL-6, IL-8)	change assessment	baseline, week 1, week 2, week 4, week 8, week 12
Secondary	depression change change	depression change assessed by Hamilton Depression Rating Scale	baseline, week 1, week 2, week 4, week 8, week 12
Secondary	manic state change	Manic symptom assessed by Young Mania Rating Scale	baseline, week 1, week 2, week 4, week 8, week 12