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

• Sponsor: Göteborg University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00996242
• Collaborator: Stanley Medical Research Institute (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 18
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: L-lysine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: L-lysine	Drug: L-lysine; 6 g/day for four weeks

Outcome Measures

Primary Outcome Measures

1. Psychotic symptoms severity [Eight weeks]

Secondary Outcome Measures

1. Treatment safety assessment [Eight weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 56 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska Univeristy Hospital	Gothenburg		Sweden	SE 405 30

Sponsors and Collaborators

• Göteborg University
• Stanley Medical Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00996242
• Other Study ID Numbers: LYSINE1; 07TGS-1049
• First Posted: Oct 16, 2009
• Last Update Posted: Oct 16, 2009
• Last Verified: Oct 1, 2009

• Keywords provided by , ,: Schizophrenia; L-lysine; PANSS
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Oct 16, 2009