An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Drug: L-lysine

• Registration Number: NCT00996242
• Lead Sponsor: Göteborg University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2008-09
• Study Completion: 2009-03
• Status Verified: 2009-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Last Update Submitted: 2009-10-15
• Study First Posted: 2009-10-16
• Last Update Posted: 2009-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
L-lysine	L-lysine	-

Primary Outcome Measures

Name	Time	Method
Psychotic symptoms severity	Eight weeks

Secondary Outcome Measures

Name	Time	Method
Treatment safety assessment	Eight weeks

Trial Locations

Locations (1)

Sahlgrenska Univeristy Hospital; 🇸🇪 Gothenburg, Sweden