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SchizophreniaPhase 2NCT02532686

DAAOI-2 add-on Treatment for Treatment-resistant Schizophrenia

A Phase 2 study testing DAAOI-2 in people with Schizophrenia, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still a difficult clinical issue at present. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
DAAOI-2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteTaiwan
Study dates
Oct 2014to Jul 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fulfill the DSM-IV criteria of schizophrenia
  • Treatment resistant: No satisfactory response to at least two kinds of antipsychotics
  • Remain symptomatic but without clinically significant fluctuation and the antipsychotic doses are unchanged for at least 3 months
  • Have a minimum baseline total score of 70 on the Positive and Negative Syndrome Scale (PANSS)
  • Agree to participate in the study and provide informed consent

Who cannot join

  • Meet DSM-IV criteria of substance (including alcohol) abuse or dependence
  • Meet DSM-IV criteria of mental retardation
  • Serious medical or neurological illness
  • Pregnancy or lactation
  • Inability to follow protocol

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Department of Psychiatry, China Medical University Hospital

    Taichung

Other trials in Taiwan

About this study

Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia 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-2, a D-amino acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agent. The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment-resistant schizophrenia patients in a randomized, double-blind, placebo-controlled trial.

Read the detailed description

Pharmacotherapy for schizophrenia has limitations such as residual positive and negative symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still a difficult clinical issue at present. 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 such as D-serine, and sarcosine (a glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive and negative symptoms.

The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment resistant schizophrenia patients in a randomized, double-blind, placebo - controlled trial.

Conditions
Schizophrenia
Being tested
DAAOI-2, placebo
Keywords
Treatment resistant, DAAOI, NMDA
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DAAOI-2Drug

    500-2000mg/d, oral, for 6 weeks

  • placeboDrug

    oral, for 6 weeks

Study groups in NCT02532686
Study groupRoleWhat they receive
DAAOI-2ExperimentalDAAOI-2: 500-2000mg/d
Receives: Drug: DAAOI-2
placeboPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive and Negative Syndrome Scale(PANSS)

    Measured: baseline

  2. Positive and Negative Syndrome Scale(PANSS)

    Measured: 2 weeks after the trial

  3. Positive and Negative Syndrome Scale(PANSS)

    Measured: 4 weeks after the trial

  4. Positive and Negative Syndrome Scale(PANSS)

    Measured: 6 weeks after the trial (The end of the trial)

  5. Assessment of Negative symptoms(SANS)

    Measured: baseline

  6. Assessment of Negative symptoms(SANS)

    Measured: 2 weeks after the trial

  7. Assessment of Negative symptoms(SANS)

    Measured: 4 weeks after the trial

  8. Assessment of Negative symptoms(SANS)

    Measured: 6 weeks after the trial (The end of the trial)

Secondary outcomes (22)

  1. PANSS subscales

    Measured: baseline

  2. PANSS subscales

    Measured: 2 weeks after the trial

  3. PANSS subscales

    Measured: 4 weeks after the trial

  4. PANSS subscales

    Measured: 6 weeks after the trial (The end of the trial)

  5. Clinical Global Impression (CGI)

    Measured: baseline

  6. Clinical Global Impression (CGI)

    Measured: 2 weeks after the trial

  7. Clinical Global Impression (CGI)

    Measured: 4 weeks after the trial

  8. Clinical Global Impression (CGI)

    Measured: 6 weeks after the trial (The end of the trial)

  9. Global assessment of function (GAF)

    Measured: baseline

  10. Global assessment of function (GAF)

    Measured: 2 weeks after the trial

  11. Global assessment of function (GAF)

    Measured: 4 weeks after the trial

  12. Global assessment of function (GAF)

    Measured: 6 weeks after the trial (The end of the trial)

  13. Hamilton Depression Rating Scale (HAMD)

    Measured: baseline

  14. Hamilton Depression Rating Scale (HAMD)

    Measured: 2 weeks after the trial

  15. Hamilton Depression Rating Scale (HAMD)

    Measured: 4 weeks after the trial

  16. Hamilton Depression Rating Scale (HAMD)

    Measured: 6 weeks after the trial (The end of the trial)

  17. Quality of life scale (QOL)

    Measured: baseline

  18. Quality of life scale (QOL)

    Measured: 2 weeks after the trial

  19. Quality of life scale (QOL)

    Measured: 4 weeks after the trial

  20. Quality of life scale (QOL)

    Measured: 6 weeks after the trial (The end of the trial)

  21. "Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS]

    An intergrated score from 7 domains:

    1. speed of processing: category fluency, trail making A, and digit symbol - coding from Wechsler adult intelligence scale (WAIS-III);
    2. sustained attention: continuous performance test;
    3. verbal and nonverbal working memory: backward digit span and spatial span from Wechsler memory scale (WMS-III);
    4. verbal learning and memory: word listing from WMS-III;
    5. visual learning and memory: visual reproduction from WMS-III;
    6. reasoning and problem solving: maze from Wechsler intelligence scale for children (WISC-III);
    7. social cognition: the managing emotions branch of Mayer-Salovey-Caruso emotional intelligence test (MSCEIT)

    Measured: baseline

  22. "Measurement and Treatment Research to Improve Cognition in Schizophrenia [MATRICS]

    An intergrated score from 7 domains:

    1. speed of processing: category fluency, trail making A, and digit symbol - coding from Wechsler adult intelligence scale (WAIS-III);
    2. sustained attention: continuous performance test;
    3. verbal and nonverbal working memory: backward digit span and spatial span from Wechsler memory scale (WMS-III);
    4. verbal learning and memory: word listing from WMS-III;
    5. visual learning and memory: visual reproduction from WMS-III;
    6. reasoning and problem solving: maze from Wechsler intelligence scale for children (WISC-III);
    7. social cognition: the managing emotions branch of Mayer-Salovey-Caruso emotional intelligence test (MSCEIT)

    Measured: 6 weeks after the trial (The end of the trial)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02532686
Sponsor's protocol ID
NSC-101-2314-B-039-030-MY3
Status last verified
Jan 2018
First submitted
10 Aug 2015
Last updated
30 Jan 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DAAOI-2 in people with Schizophrenia, run by China Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive and Negative Syndrome Scale(PANSS) (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02532686.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.

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