DAAOI-1 Treatment for Treatment-resistant Schizophrenia

Schizophrenia Clinical Trial

Official title:

DAAOI-1 Treatment for Treatment-resistant Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01390376
• Other study ID #: DOH99-TD-I-111-TM001
• Status: Recruiting
• Phase: Phase 2
• First received: July 7, 2011
• Last updated: July 31, 2013
• Start date: September 2010
• Est. completion date: December 2014

Study information

• Verified date: July 2013
• Source: China Medical University Hospital
• Contact: Hsien-Yuan Lane, M.D., Ph.D
• Phone: 886 921 067260
• Email: hylane[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA) hypothesis, adjuvant NMDA-enhancing agents may have therapeutic benefit. DAAOI-1, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agents.

The aim of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant treatment for clozapine-resistant refractory schizophrenia patients in a randomized, double-blind, placebo - controlled trial.

Description:

Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia (particularly clozapine-resistant) is still a difficult clinical issue at present. Among schizophrenia patients, around 20-25%are treatment-resistant. According to the N-methyl-D-aspartate (NMDA) hypothesis, many clinical trials on NMDA-enhancing agents were studied. Adjuvant NMDA-enhancing agents, including glycine, D-amino acids (D-serine, D-alanine), and sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms. The investigators recently started to study the potential of DAAOI-1, a D-amino acid oxidase (DAAO) inhibitor which can elevate synaptic concentration of D-amino acids.

The aims of this project is to examine the effectiveness and safety of DAAOI-1 adjuvant treatment for clozapine-resistant refractory schizophrenia patients in a randomized, double-blind, placebo - controlled trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Fulfilled the DSM-IV criteria of schizophrenia

• Poor responder of clozapine: a 12-week treatment at adequate plasma concentration without satisfactory response: a minimal total score of 70 on the Positive and Negative Syndrome Scale (PANSS) (Kay 1987), and a minimal total score of 40 on the Scale for the Assessment of Negative Symptoms (SANS) (Andreasen 1983).

• Agree to participate in the study and provide informed consent

Exclusion Criteria:

• Meet DSM-IV criteria of other AXIS I disorder, current substance dependence or mental retardation

• Serious medical or neurological illness

• Pregnancy or lactation

• Use of depot antipsychotic in the past 6 months

• Inability to follow protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• DAAOI-1
DAAOI-1 1g
• DAAOI-1
DAAOI-1 2g
• placebo
starch pill

Locations

Country	Name	City	State
Taiwan	Department of Psychiatry, China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	Department of Health, Executive Yuan, R.O.C. (Taiwan)

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The severity of psychiatric symptoms	The severity of psychiatric symptoms will be assessed by: Positive and Negative Syndrome Scale(PANSS); Assessment of Negative symptoms(SANS); Global assessment of function(GAF); Quality of life scale(QOL)	week 0, 2, 4, 6	No
Secondary	PANSS subscales	score changes	week 0,2,4,6	No
Secondary	Hamilton Depression Rating Scale (HAMD)		Week 0,2,4, 6	No
Secondary	Cognitive function	7 domains of Measurement and Treatment Research to Improve Cognition in Schizophrenia" [MATRICS]	week 0, 6	No