Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
13 participants
INTERVENTIONAL
2003-08-31
2008-05-31
Brief Summary
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D-serine will be used as add-on therapy to on-going medications received by Parkinson's Disease patients. The rational for this study stems from observations made in pervious clinical trials with schizophrenia patients, in which it was demonstrated that D-serine adjuvant treatment resulted in:1)improvement of parkinsonian side effects induced by antipsychotic drugs and 2) improvement of depression and negative (i.e apathy, blunted effects, anhedonia) symptoms which are similar to symptoms encountered in Parkinson's Disease.
The study will have a crossover design in accordance to which each patient will receive, in random order D-serine and placebo for a 6 weeks period each. Thus, any participant will have the opportunity to receive the experimental treatment.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TRIPLE
Study Groups
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1
D-serine (~2g/day)
Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine (\~2g/day). Second arm : adjuvant treatment with placebo (\~2g/day).
2
D-serine (~2g/day)
Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine (\~2g/day). Second arm : adjuvant treatment with placebo (\~2g/day).
Interventions
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D-serine (~2g/day)
Two 6 weeks treatment arms. One arm: adjuvant treatment with D-serine (\~2g/day). Second arm : adjuvant treatment with placebo (\~2g/day).
Eligibility Criteria
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Inclusion Criteria
* ≥2 on UPDRS items 32,33
* receive treatment with L-dopa alone or in combination with other antiparkinsonian medications.
Exclusion Criteria
* unstable medical conditions
* renal pathology
* pregnant female patients excluded
30 Years
75 Years
ALL
No
Sponsors
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Herzog Hospital
OTHER
Responsible Party
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Heresco-Levi Uriel
Princepal Investigator
Principal Investigators
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Uriel Heresco-Levy
Role: PRINCIPAL_INVESTIGATOR
Ezrath Nashim - Herzog Memorial Hospital
Locations
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Ezrath Nashim - Herzog Memorial Hospital
Jerusalem, , Israel
Countries
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References
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Gelfin E, Kaufman Y, Korn-Lubetzki I, Bloch B, Kremer I, Javitt DC, Heresco-Levy U. D-serine adjuvant treatment alleviates behavioural and motor symptoms in Parkinson's disease. Int J Neuropsychopharmacol. 2012 May;15(4):543-9. doi: 10.1017/S1461145711001015. Epub 2011 Jul 7.
Other Identifiers
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20030312
Identifier Type: -
Identifier Source: secondary_id
Heresco1CTIL
Identifier Type: -
Identifier Source: org_study_id