Predictors of Functional Remission in Discharged Patients With Schizophrenia After Long-term Drug Discontinuation

An observational study of Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.

Completed

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

Trial summary

Study objectives: 1. Describe the characteristics of discharged patients with schizophrenia achieving functional remission after drug discontinuation. 2. Establish a prediction model of patients with schizophrenia having good prognosis after drug discontinuation. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
How many people: 480 participants
Where: 1 siteChina
Study dates: 15 Sep 2022to 31 Mar 2025
Phase: Observational
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

Study population: All participants will be recruited from Shanghai Mental Health Center (SMHC), Shanghai, China

Who may be able to join

Patients who met the diagnostic criteria of the International Classification of diseases, 10th edition (ICD-10) for a diagnosis of schizophrenia;
Aged between 18 to 65 years old at time of investigation;
Hospitalized in Shanghai Mental Health Center any time from the year 2013 to 2018;
Informed consent.

Who cannot join

Patients with neurological diseases, severe somatic diseases, psychoactive substance abuse, mental retardation, agitation, stupor, or risk of suicide, and female patients who are pregnant or breast-feeding, will be excluded from the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: Predictors of Functional Remission in Discharged Patients With Schizophrenia After Long-term Drug Discontinuation: a Case-control Study

Study objectives:

Describe the characteristics of discharged patients with schizophrenia achieving functional remission after drug discontinuation.
Establish a prediction model of patients with schizophrenia having good prognosis after drug discontinuation.

Read the detailed description

There are 2 clinically important and urgent questions to be explored in this study: 1. Who is more likely to benefit from guided drug reduction or discontinuation? How to design an individualized treatment plan which can balance the risk of relapse and side-effects from antipsychotics? 2. What are the predictors of functional remission in patients with schizophrenia after drug discontinuation? This will be the first related study to be conducted in China.

Conditions: Schizophrenia
Medical subject headings: Schizophrenia

What participants receive

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

Study groups in NCT05667961
Study group	Role	What they receive
the function remitted off-medicine group		* Off-medicine definition: Continuous antipsychotic maintenance therapy for at least two years before drug discontinuation and drug discontinuation of all reasons (treatment benefits, adverse events, socioeconomic difficulties, migration, stigma, etc.) for at least one year; * Function remitted definition: Meet the criteria of functional remission in both WHOQoL-BREF (overall points ≥ 60) and FROGS (social functioning dimension points ≥ 33, daily life dimension points ≥ 12, and treatment dimension points ≥ 12)
the function not-remitted off-medicine group		* Off-medicine definition: Continuous antipsychotic maintenance therapy for at least two years before drug discontinuation and drug discontinuation of all reasons (treatment benefits, adverse events, socioeconomic difficulties, migration, stigma, etc.) for at least one year; * Function not-remitted definition: Fail to meet the criteria of functional remission in both WHOQoL-BREF and FROGS
the function remitted on-medicine group		* On-medicine definition: Continuous antipsychotic maintenance therapy during the time this study is conducted * Function remitted definition: Meet the criteria of functional remission in both WHOQoL-BREF and FROGS
the function not-remitted on-medicine group		* On-medicine definition: Continuous antipsychotic maintenance therapy during the time this study is conducted * Function not-remitted definition: Fail to meet the criteria of functional remission in both WHOQoL-BREF and FROGS

What is being measured

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

Functional remission dimension 1
World Health Organization Quality of Life abbreviated version（WHOQoL-BREF), score from 26 to 130. Higher score indicates better functional remission.
Measured: Up to 28 weeks
Functional remission dimension 2
Functional Remission of General Schizophrenia Scale (FROGS), scale from 19 to 95. Higher score indicates better functional remission.
Measured: Up to 28 weeks

Secondary outcomes (2)

Symptom assessment dimension 1
the Positive and Negative Syndrome Scale (PANSS), score from 30 to 210. High score indicates severe symptoms.
Measured: Up to 28 weeks
Symptom assessment dimension 2
Clinical Global Impression (CGI), score from 1 to 7. High score indicates severe symptoms.
Measured: Up to 28 weeks

Timeline

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

15 Sep 202231 Mar 2025

First posted29 Dec 2022
Study start15 Sep 2022
Primary completion31 Jan 2025
Study completion31 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 480 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05667961
Sponsor's protocol ID: 2022-TX-007
Status last verified: Apr 2025
First submitted: 6 Sep 2022
Last updated: 25 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will be securely protected and will not be shared to other researchers.

Publications

Fitzgerald P, de Castella A, Arya D, Simons WR, Eggleston A, Meere S, Kulkarni J. The cost of relapse in schizophrenia and schizoaffective disorder. Australas Psychiatry. 2009 Aug;17(4):265-72. doi: 10.1080/10398560903002998.
PubMed 19585288
Kane JM. Treatment strategies to prevent relapse and encourage remission. J Clin Psychiatry. 2007;68 Suppl 14:27-30.
PubMed 18284275
Takeuchi H, Siu C, Remington G, Fervaha G, Zipursky RB, Foussias G, Agid O. Does relapse contribute to treatment resistance? Antipsychotic response in first- vs. second-episode schizophrenia. Neuropsychopharmacology. 2019 May;44(6):1036-1042. doi: 10.1038/s41386-018-0278-3. Epub 2018 Nov 22.
PubMed 30514883
De Hert M, Sermon J, Geerts P, Vansteelandt K, Peuskens J, Detraux J. The Use of Continuous Treatment Versus Placebo or Intermittent Treatment Strategies in Stabilized Patients with Schizophrenia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials with First- and Second-Generation Antipsychotics. CNS Drugs. 2015 Aug;29(8):637-58. doi: 10.1007/s40263-015-0269-4.
PubMed 26293744
Sampson S, Joshi K, Mansour M, Adams CE. Intermittent drug techniques for schizophrenia. Schizophr Bull. 2013 Sep;39(5):960-1. doi: 10.1093/schbul/sbt096. Epub 2013 Jul 16.
PubMed 23861538
Tiihonen J, Tanskanen A, Taipale H. 20-Year Nationwide Follow-Up Study on Discontinuation of Antipsychotic Treatment in First-Episode Schizophrenia. Am J Psychiatry. 2018 Aug 1;175(8):765-773. doi: 10.1176/appi.ajp.2018.17091001. Epub 2018 Apr 6.
PubMed 29621900
Gaebel W, Stricker J, Riesbeck M. The long-term antipsychotic treatment of schizophrenia: A selective review of clinical guidelines and clinical case examples. Schizophr Res. 2020 Nov;225:4-14. doi: 10.1016/j.schres.2019.10.049. Epub 2019 Dec 2.
PubMed 31806527
Zito MF, Marder SR. Rethinking the risks and benefits of long-term maintenance in schizophrenia. Schizophr Res. 2020 Nov;225:77-81. doi: 10.1016/j.schres.2019.10.057. Epub 2019 Dec 2.
PubMed 31806525
Haijma SV, Van Haren N, Cahn W, Koolschijn PC, Hulshoff Pol HE, Kahn RS. Brain volumes in schizophrenia: a meta-analysis in over 18 000 subjects. Schizophr Bull. 2013 Sep;39(5):1129-38. doi: 10.1093/schbul/sbs118. Epub 2012 Oct 5.
PubMed 23042112
Morgan C, Lappin J, Heslin M, Donoghue K, Lomas B, Reininghaus U, Onyejiaka A, Croudace T, Jones PB, Murray RM, Fearon P, Doody GA, Dazzan P. Reappraising the long-term course and outcome of psychotic disorders: the AESOP-10 study. Psychol Med. 2014 Oct;44(13):2713-26. doi: 10.1017/S0033291714000282. Epub 2014 Feb 26.
PubMed 25066181
Wunderink L, Nienhuis FJ, Sytema S, Slooff CJ, Knegtering R, Wiersma D. Guided discontinuation versus maintenance treatment in remitted first-episode psychosis: relapse rates and functional outcome. J Clin Psychiatry. 2007 May;68(5):654-61. doi: 10.4088/jcp.v68n0502.
PubMed 17503973
Wils RS, Gotfredsen DR, Hjorthoj C, Austin SF, Albert N, Secher RG, Thorup AA, Mors O, Nordentoft M. Antipsychotic medication and remission of psychotic symptoms 10years after a first-episode psychosis. Schizophr Res. 2017 Apr;182:42-48. doi: 10.1016/j.schres.2016.10.030. Epub 2016 Oct 27.
PubMed 28277310
Hui CLM, Honer WG, Lee EHM, Chang WC, Chan SKW, Chen ESM, Pang EPF, Lui SSY, Chung DWS, Yeung WS, Ng RMK, Lo WTL, Jones PB, Sham P, Chen EYH. Long-term effects of discontinuation from antipsychotic maintenance following first-episode schizophrenia and related disorders: a 10 year follow-up of a randomised, double-blind trial. Lancet Psychiatry. 2018 May;5(5):432-442. doi: 10.1016/S2215-0366(18)30090-7. Epub 2018 Mar 15.
PubMed 29551618
Boyer L, Richieri R, Guedj E, Faget-Agius C, Loundou A, Llorca PM, Auquier P, Lancon C. Validation of a functional remission threshold for the Functional Remission of General Schizophrenia (FROGS) scale. Compr Psychiatry. 2013 Oct;54(7):1016-22. doi: 10.1016/j.comppsych.2013.04.008. Epub 2013 May 31.
PubMed 23731897
Silva SM, Santana ANC, Silva NNBD, Novaes MRCG. VES-13 and WHOQOL-bref cutoff points to detect quality of life in older adults in primary health care. Rev Saude Publica. 2019 Apr 1;53:26. doi: 10.11606/S1518-8787.2019053000802.
PubMed 30942268

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predictors of Functional Remission in Discharged Patients With Schizophrenia After Long-term Drug Discontinuation: a Case-control Study
ClinicalTrials.gov ID: NCT05667961
Acronym / sponsor ID: 2022-TX-007
Conditions: Schizophrenia
Study type: Observational
Recruitment status: Completed
Enrolment: 480 participants (actual)
Lead sponsor: Shanghai Mental Health CenterUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: 15 Sep 2022 (actual)
Primary completion: 31 Jan 2025 (actual)
Study completion: 31 Mar 2025 (actual)
First posted: 29 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study objectives:

Describe the characteristics of discharged patients with schizophrenia achieving functional remission after drug discontinuation.
Establish a prediction model of patients with schizophrenia having good prognosis after drug discontinuation.

Detailed description

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
the function remitted off-medicine group	–	–* Off-medicine definition: Continuous antipsychotic maintenance therapy for at least two years before drug discontinuation and drug discontinuation of all reasons (treatment benefits, adverse events, socioeconomic difficulties, migration, stigma, etc.) for at least one year; * Function remitted definition: Meet the criteria of functional remission in both WHOQoL-BREF (overall points ≥ 60) and FROGS (social functioning dimension points ≥ 33, daily life dimension points ≥ 12, and treatment dimension points ≥ 12)
the function not-remitted off-medicine group	–	–* Off-medicine definition: Continuous antipsychotic maintenance therapy for at least two years before drug discontinuation and drug discontinuation of all reasons (treatment benefits, adverse events, socioeconomic difficulties, migration, stigma, etc.) for at least one year; * Function not-remitted definition: Fail to meet the criteria of functional remission in both WHOQoL-BREF and FROGS
the function remitted on-medicine group	–	–* On-medicine definition: Continuous antipsychotic maintenance therapy during the time this study is conducted * Function remitted definition: Meet the criteria of functional remission in both WHOQoL-BREF and FROGS
the function not-remitted on-medicine group	–	–* On-medicine definition: Continuous antipsychotic maintenance therapy during the time this study is conducted * Function not-remitted definition: Fail to meet the criteria of functional remission in both WHOQoL-BREF and FROGS

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All participants will be recruited from Shanghai Mental Health Center (SMHC), Shanghai, China

Key inclusion criteria (4 listed)

Patients who met the diagnostic criteria of the International Classification of diseases, 10th edition (ICD-10) for a diagnosis of schizophrenia;
Aged between 18 to 65 years old at time of investigation;
Hospitalized in Shanghai Mental Health Center any time from the year 2013 to 2018;
Informed consent.

Key exclusion criteria (1 listed)

Patients with neurological diseases, severe somatic diseases, psychoactive substance abuse, mental retardation, agitation, stupor, or risk of suicide, and female patients who are pregnant or breast-feeding, will be excluded from the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Functional remission dimension 1
Time frame: Up to 28 weeks
World Health Organization Quality of Life abbreviated version（WHOQoL-BREF), score from 26 to 130. Higher score indicates better functional remission.
Functional remission dimension 2
Time frame: Up to 28 weeks
Functional Remission of General Schizophrenia Scale (FROGS), scale from 19 to 95. Higher score indicates better functional remission.

2 secondary outcomes

Symptom assessment dimension 1
Time frame: Up to 28 weeks
Symptom assessment dimension 2
Time frame: Up to 28 weeks

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
Background: PubMed 19585288Fitzgerald P, de Castella A, Arya D, Simons WR, Eggleston A, Meere S, Kulkarni J. The cost of relapse in schizophrenia and schizoaffective disorder. Australas Psychiatry. 2009 Aug;17(4):265-72. doi: 10.1080/10398560903002998.
Background: PubMed 18284275Kane JM. Treatment strategies to prevent relapse and encourage remission. J Clin Psychiatry. 2007;68 Suppl 14:27-30.
Background: PubMed 30514883Takeuchi H, Siu C, Remington G, Fervaha G, Zipursky RB, Foussias G, Agid O. Does relapse contribute to treatment resistance? Antipsychotic response in first- vs. second-episode schizophrenia. Neuropsychopharmacology. 2019 May;44(6):1036-1042. doi: 10.1038/s41386-018-0278-3. Epub 2018 Nov 22.
Background: PubMed 26293744De Hert M, Sermon J, Geerts P, Vansteelandt K, Peuskens J, Detraux J. The Use of Continuous Treatment Versus Placebo or Intermittent Treatment Strategies in Stabilized Patients with Schizophrenia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials with First- and Second-Generation Antipsychotics. CNS Drugs. 2015 Aug;29(8):637-58. doi: 10.1007/s40263-015-0269-4.
Background: PubMed 23861538Sampson S, Joshi K, Mansour M, Adams CE. Intermittent drug techniques for schizophrenia. Schizophr Bull. 2013 Sep;39(5):960-1. doi: 10.1093/schbul/sbt096. Epub 2013 Jul 16.
Background: PubMed 29621900Tiihonen J, Tanskanen A, Taipale H. 20-Year Nationwide Follow-Up Study on Discontinuation of Antipsychotic Treatment in First-Episode Schizophrenia. Am J Psychiatry. 2018 Aug 1;175(8):765-773. doi: 10.1176/appi.ajp.2018.17091001. Epub 2018 Apr 6.
Background: PubMed 31806527Gaebel W, Stricker J, Riesbeck M. The long-term antipsychotic treatment of schizophrenia: A selective review of clinical guidelines and clinical case examples. Schizophr Res. 2020 Nov;225:4-14. doi: 10.1016/j.schres.2019.10.049. Epub 2019 Dec 2.
Background: PubMed 31806525Zito MF, Marder SR. Rethinking the risks and benefits of long-term maintenance in schizophrenia. Schizophr Res. 2020 Nov;225:77-81. doi: 10.1016/j.schres.2019.10.057. Epub 2019 Dec 2.
Background: PubMed 23042112Haijma SV, Van Haren N, Cahn W, Koolschijn PC, Hulshoff Pol HE, Kahn RS. Brain volumes in schizophrenia: a meta-analysis in over 18 000 subjects. Schizophr Bull. 2013 Sep;39(5):1129-38. doi: 10.1093/schbul/sbs118. Epub 2012 Oct 5.
Background: PubMed 25066181Morgan C, Lappin J, Heslin M, Donoghue K, Lomas B, Reininghaus U, Onyejiaka A, Croudace T, Jones PB, Murray RM, Fearon P, Doody GA, Dazzan P. Reappraising the long-term course and outcome of psychotic disorders: the AESOP-10 study. Psychol Med. 2014 Oct;44(13):2713-26. doi: 10.1017/S0033291714000282. Epub 2014 Feb 26.
Background: PubMed 17503973Wunderink L, Nienhuis FJ, Sytema S, Slooff CJ, Knegtering R, Wiersma D. Guided discontinuation versus maintenance treatment in remitted first-episode psychosis: relapse rates and functional outcome. J Clin Psychiatry. 2007 May;68(5):654-61. doi: 10.4088/jcp.v68n0502.
Background: PubMed 28277310Wils RS, Gotfredsen DR, Hjorthoj C, Austin SF, Albert N, Secher RG, Thorup AA, Mors O, Nordentoft M. Antipsychotic medication and remission of psychotic symptoms 10years after a first-episode psychosis. Schizophr Res. 2017 Apr;182:42-48. doi: 10.1016/j.schres.2016.10.030. Epub 2016 Oct 27.
Individual participant dataSharing planned: No. Individual participant data (IPD) will be securely protected and will not be shared to other researchers.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dengtang Liu principal investigator

Shanghai Mental Health Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.

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 4 inclusion and 1 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 25 Apr 2025. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Functional remission dimension 1 (time frame: Up to 28 weeks). The study lists 2 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 NCT05667961, which also lists 20 linked publications.

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 25 Apr 2025.