An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia
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Purpose
The objective of the present study was to investigate the possibility of using L-lysine, an amino acid that occurs naturally in food and which interferes with nitric oxide (NO) production, for the treatment of schizophrenia. L-lysine, 6 g/day, was administered to ten patients with schizophrenia as an add-on treatment to conventional antipsychotic treatment. The study was designed as a single-blinded, cross-over study where patients were randomly assigned to initial treatment with either L-lysine or placebo and screened at baseline, after four weeks when treatment was crossed over, and after eight weeks when treatment was terminated. The four-week L-lysine treatment regimen caused a significant increased in blood concentration of the amino acid and was tolerated well. The analysis of outcome measures showed a significant decrease in symptom severity as measured by the Positive and Negative Syndrome Scale (PANSS). Furthermore, the patient's ability to solve the Wisconsin Card Sorting Task (WCST) was significantly improved indicating increased problem solving capacity and cognitive flexibility. Subjective reports from three of the patients also indicated decreased symptom severity and enhanced cognitive functioning. In summary, these findings suggest potential beneficial effects of L-lysine treatment on symptom severity and cognitive deficits in patients with schizophrenia.
| Condition | Intervention |
|---|---|
|
Schizophrenia |
Drug: L-lysine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia |
- Psychotic symptoms severity [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
- Treatment safety assessment [ Time Frame: Eight weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 10 |
| Study Start Date: | September 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: L-lysine |
Drug: L-lysine
6 g/day for four weeks
|
Eligibility| Ages Eligible for Study: | 23 Years to 56 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- a stable phase of illness
- a stable dose of antipsychotic medication
- no other major medical conditions or other psychiatric diagnosis
- normal admission laboratory tests and vital signs
Exclusion Criteria:
- substance abuse, apart from smoking
Contacts and Locations
More Information
No publications provided by Göteborg University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Birgitta Rembeck, PhD, The Sahlgrenska University Hospital, Gothenburg, Sweden |
| ClinicalTrials.gov Identifier: | NCT00996242 History of Changes |
| Other Study ID Numbers: | LYSINE1, 07TGS-1049 |
| Study First Received: | October 15, 2009 |
| Last Updated: | October 15, 2009 |
| Health Authority: | Sweden: Gothenburg Regional Review Board Sweden: Medical Products Agency |
Keywords provided by Göteborg University:
|
Schizophrenia L-lysine PANSS |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013