search
Back to results

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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
L-lysine
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, L-lysine, PANSS

Eligibility Criteria

23 Years - 56 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska Univeristy Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

L-lysine

Arm Description

Outcomes

Primary Outcome Measures

Psychotic symptoms severity

Secondary Outcome Measures

Treatment safety assessment

Full Information

First Posted
October 15, 2009
Last Updated
October 15, 2009
Sponsor
Göteborg University
Collaborators
Stanley Medical Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00996242
Brief Title
An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia
Official Title
An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Göteborg University
Collaborators
Stanley Medical Research Institute

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, L-lysine, PANSS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L-lysine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
L-lysine
Intervention Description
6 g/day for four weeks
Primary Outcome Measure Information:
Title
Psychotic symptoms severity
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Treatment safety assessment
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sahlgrenska Univeristy Hospital
City
Gothenburg
ZIP/Postal Code
SE 405 30
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21501494
Citation
Wass C, Klamer D, Katsarogiannis E, Palsson E, Svensson L, Fejgin K, Bogren IB, Engel JA, Rembeck B. L-lysine as adjunctive treatment in patients with schizophrenia: a single-blinded, randomized, cross-over pilot study. BMC Med. 2011 Apr 18;9:40. doi: 10.1186/1741-7015-9-40.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs