SchizophreniaPhase 2SUPPORT-SCZNCT07477301
Supportive Psychotherapy as Adjunct to Risperidone for Cognitive Function and Inflammation in Schizophrenia
A Phase 2 study testing Structured Supportive Psychotherapy and Risperidone 2 mg in people with Schizophrenia and Cognitive Dysfunction, run by Hasanuddin University at 1 site in Indonesia.
Trial summary
This study examined whether adding structured supportive psychotherapy to risperidone treatment is more effective than risperidone alone in improving cognitive function and reducing inflammation in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Schizophrenia, Cognitive Dysfunction, Inflamation
- What is being tested?
- Structured Supportive Psychotherapy and Risperidone 2 mg
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2024to 28 Feb 2025
- 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 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients diagnosed with schizophrenia according to DSM-5 criteria
- Aged 20-45 years
- Disease onset less than one year
- Insight level grade 4
- PANSS-EC score 14 or less
- Total PANSS score 60-70
Show all 10Show fewer
- No febrile conditions, jaundice, or hepatosplenomegaly
- Willing and able to attend supportive psychotherapy sessions
- Receiving risperidone at fixed dose of 4 mg per day
- South Sulawesi ethnic origin
Who cannot join
- Organic comorbid diseases
- History of substance abuse within previous six months except caffeine and nicotine
- Comorbid personality disorders
- Obesity
- Active infectious diseases
- Use of anti-inflammatory agents, antibiotics, or antioxidant supplements
- Female sex
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supportive Psychotherapy As An Adjunct To Risperidone Improves Cognitive Function And Reduces High-Sensitivity C-Reactive Protein (Hs-CRP) In Schizophrenia: A Randomized Controlled Trial
This study examined whether adding structured supportive psychotherapy to risperidone treatment is more effective than risperidone alone in improving cognitive function and reducing inflammation in patients with schizophrenia.
Forty-six male patients with schizophrenia were randomly assigned to two groups: the intervention group (n=23) received risperidone 4 mg/day plus 12 sessions of structured supportive psychotherapy over 6 weeks. The control group (n=23) received risperidone 4 mg/day alone for 6 weeks.
Read more
Cognitive function was measured using the Montreal Cognitive Assessment - Indonesian version (MoCA-Ina) and inflammation was measured using serum high-sensitivity C-reactive protein (hs-CRP) levels, both assessed at baseline (Week 0) and after treatment (Week 6).
NOTE: This trial was retrospectively registered. The study was conducted from December 2024 to February 2025 and received ethical clearance (No. 1009/UN4.6.4.5.31/PP36/2024) from the Biomedical Research Ethics Committee, Faculty of Medicine, Universitas Hasanuddin, prior to study initiation. Registration was performed after study completion due to the investigator's initial unawareness of prospective registration requirements. No outcome measures, study design, or statistical analysis plan were modified following data collection.
Read the detailed description
This double-blind randomized controlled trial was conducted at Dadi Psychiatric Hospital (RSJ Dadi), South Sulawesi Province, Makassar, Indonesia, from December 2024 to February 2025.
BACKGROUND:
Schizophrenia is associated with cognitive impairment and elevated inflammatory markers, including high-sensitivity C-reactive protein (hs-CRP). Supportive psychotherapy has been proposed as an adjunctive intervention to pharmacotherapy to address these deficits. However, evidence on the combined effect of supportive psychotherapy and risperidone on both cognitive function and inflammation remains limited.
INTERVENTION:
The intervention group received risperidone 4 mg/day (2 mg twice daily) plus structured supportive psychotherapy consisting of 12 sessions delivered twice weekly over 6 weeks (15-30 minutes per session). The control group received risperidone 4 mg/day monotherapy for 6 weeks. To minimize expectation bias, supportive psychotherapy was described to all participants as "standard supportive counseling," thereby preventing identification of group allocation.
RANDOMIZATION AND BLINDING:
Participants were randomly allocated in a 1:1 ratio using a simple random number generator by an independent researcher not involved in clinical recruitment. Allocation concealment was achieved using the Sequentially Numbered Opaque Sealed Envelope (SNOSE) method, prepared by a separate research assistant and disclosed only after informed consent and baseline assessments were completed. Participants 1-23 were assigned to the intervention group and participants 24-46 to the control group. The study employed a double-blind design in which both participants and outcome assessors were blinded to group allocation. Outcome assessors evaluating MoCA-Ina scores and laboratory personnel measuring serum hs-CRP levels were fully blinded to group allocation throughout the study period.
OUTCOME MEASURES:
Primary outcomes were: (1) change in cognitive function assessed by Montreal Cognitive Assessment - Indonesian version (MoCA-Ina) from baseline to Week 6; and (2) change in serum hs-CRP level from baseline to Week 6. Secondary outcome was the correlation between delta hs-CRP and delta MoCA-Ina within each group at Week 6.
ETHICAL APPROVAL:
This study was approved by the Biomedical Research Ethics Committee, Faculty of Medicine, Universitas Hasanuddin (No. 1009/UN4.6.4.5.31/PP36/2024) and conducted in accordance with the Declaration of Helsinki. All participants provided written informed consent prior to enrollment.
NOTE: This trial was retrospectively registered. The study was conducted from December 2024 to February 2025 and received ethical clearance prior to study initiation. Registration was performed after study completion due to the investigator's initial unawareness of prospective registration requirements. No outcome measures, study design, or statistical analysis plan were modified following data collection.
- Conditions
- Schizophrenia, Cognitive Dysfunction, Inflamation
- Being tested
- Structured Supportive Psychotherapy, Risperidone 2 mg
- Keywords
- Schizophrenia, Supportive Psychotherapy, Risperidone, Cognitive Function, C-Reactive Protein, Randomized Controlled Trial, Inflammation
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Supportive PsychotherapyBehavioural
Structured supportive psychotherapy using the Supportive Psychotherapy Module for Schizophrenia (Suhuyanli et al.), nationally validated in the Indonesian population. Consisting of 12 structured sessions delivered twice weekly over 6 weeks (15-30 minutes per session), organized into initial (sessions 1-3), middle (sessions 4-9), and termination phases (sessions 10-12). Sessions were delivered by three trained psychiatrists supervised by a consultant in medical psychotherapy. To minimize expectation bias, the intervention was described to all participants as "standard supportive counseling."
Risperidone 2 mgDrug
Risperidone 4 mg/day (2 mg tablet twice daily, oral administration) for 6 weeks. Administered to both the intervention group (in combination with supportive psychotherapy) and the control group (as monotherapy).
| Study group | Role | What they receive |
|---|---|---|
| Supportive Psychotherapy plus Risperidone | Experimental | Participants received risperidone 4 mg/day (2 mg tablet twice daily, oral administration) plus structured supportive psychotherapy consisting of 12 sessions delivered twice weekly over 6 weeks (15-30 minutes per session). Supportive psychotherapy was delivered using a validated module by the principal investigator. Receives: Behavioral: Structured Supportive Psychotherapy; Drug: Risperidone 2 mg |
| Risperidone Monotherapy | Active comparator | Participants received risperidone 4 mg/day (2 mg tablet twice daily, oral administration) monotherapy for 6 weeks without any structured psychotherapy intervention. Receives: Drug: Risperidone 2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function (MoCA-Ina Score)
Change in cognitive function assessed by the Montreal Cognitive Assessment - Indonesian version (MoCA-Ina) from baseline to Week 6. Score range 0-30; higher scores indicate better cognitive function. Inter-rater reliability kappa=0.820.
Measured: Baseline (Week 0) and post-intervention (Week 6)
Change in Serum hs-CRP Level
Change in serum high-sensitivity C-reactive protein (hs-CRP) level from baseline to Week 6, measured by Sandwich-ELISA (Elabscience Human hs-CRP ELISA Kit, Cat. No. E-EL-H5134; detection range 15.63-1000 pg/mL; sensitivity 9.38 pg/mL).
Measured: Baseline (Week 0) and post-intervention (Week 6)
Secondary outcomes (1)
Correlation Between Delta hs-CRP and Delta MoCA-Ina
Correlation between change in serum hs-CRP level (delta hs-CRP) and change in cognitive function score (delta MoCA-Ina) within each group at Week 6. Analyzed using Spearman or Pearson correlation coefficient based on normality test (Shapiro-Wilk). Delta values calculated as Week 6 minus Week 0 for each measure.
Measured: Week 6 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Dec 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This parallel-group RCT compared two arms over 6 weeks. Participants were randomly allocated in a 1:1 ratio using a simple random number generator by an independent researcher not involved in clinical recruitment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agus Durman, Hasanuddin University
- Investigators
- Agus Durman, MD, Principal investigator, Department of Psychiatry, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, IndonesiaIndrawaty Suhuyanli, MD, Study chair, Department of Psychiatry, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477301
- Sponsor's protocol ID
- AGUS-SP-RIS-SCZ-2024
- Acronym
- SUPPORT-SCZ
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Psychotherapy As An Adjunct To Risperidone Improves Cognitive Function And Reduces High-Sensitivity C-Reactive Protein (Hs-CRP) In Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07477301
- Acronym / sponsor ID
- SUPPORT-SCZ / AGUS-SP-RIS-SCZ-2024
- Conditions
- Schizophrenia, Cognitive Dysfunction, Inflamation
- Keywords
- Schizophrenia, Supportive Psychotherapy, Risperidone, Cognitive Function, C-Reactive Protein, Randomized Controlled Trial, Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 17 Mar 2026 (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.
This study examined whether adding structured supportive psychotherapy to risperidone treatment is more effective than risperidone alone in improving cognitive function and reducing inflammation in patients with schizophrenia.
Forty-six male patients with schizophrenia were randomly assigned to two groups: the intervention group (n=23) received risperidone 4 mg/day plus 12 sessions of structured supportive psychotherapy over 6 weeks. The control group (n=23) received risperidone 4 mg/day alone for 6 weeks.
Cognitive function was measured using the Montreal Cognitive Assessment - Indonesian version (MoCA-Ina) and inflammation was measured using serum high-sensitivity C-reactive protein (hs-CRP) levels, both assessed at baseline (Week 0) and after treatment (Week 6).
NOTE: This trial was retrospectively registered. The study was conducted from December 2024 to February 2025 and received ethical clearance (No. 1009/UN4.6.4.5.31/PP36/2024) from the Biomedical Research Ethics Committee, Faculty of Medicine, Universitas Hasanuddin, prior to study initiation. Registration was performed after study completion due to the investigator's initial unawareness of prospective registration requirements. No outcome measures, study design, or statistical analysis plan were modified following data collection.
Detailed description
This double-blind randomized controlled trial was conducted at Dadi Psychiatric Hospital (RSJ Dadi), South Sulawesi Province, Makassar, Indonesia, from December 2024 to February 2025.
BACKGROUND:
Schizophrenia is associated with cognitive impairment and elevated inflammatory markers, including high-sensitivity C-reactive protein (hs-CRP). Supportive psychotherapy has been proposed as an adjunctive intervention to pharmacotherapy to address these deficits. However, evidence on the combined effect of supportive psychotherapy and risperidone on both cognitive function and inflammation remains limited.
INTERVENTION:
The intervention group received risperidone 4 mg/day (2 mg twice daily) plus structured supportive psychotherapy consisting of 12 sessions delivered twice weekly over 6 weeks (15-30 minutes per session). The control group received risperidone 4 mg/day monotherapy for 6 weeks. To minimize expectation bias, supportive psychotherapy was described to all participants as "standard supportive counseling," thereby preventing identification of group allocation.
RANDOMIZATION AND BLINDING:
Participants were randomly allocated in a 1:1 ratio using a simple random number generator by an independent researcher not involved in clinical recruitment. Allocation concealment was achieved using the Sequentially Numbered Opaque Sealed Envelope (SNOSE) method, prepared by a separate research assistant and disclosed only after informed consent and baseline assessments were completed. Participants 1-23 were assigned to the intervention group and participants 24-46 to the control group. The study employed a double-blind design in which both participants and outcome assessors were blinded to group allocation. Outcome assessors evaluating MoCA-Ina scores and laboratory personnel measuring serum hs-CRP levels were fully blinded to group allocation throughout the study period.
OUTCOME MEASURES:
Primary outcomes were: (1) change in cognitive function assessed by Montreal Cognitive Assessment - Indonesian version (MoCA-Ina) from baseline to Week 6; and (2) change in serum hs-CRP level from baseline to Week 6. Secondary outcome was the correlation between delta hs-CRP and delta MoCA-Ina within each group at Week 6.
ETHICAL APPROVAL:
This study was approved by the Biomedical Research Ethics Committee, Faculty of Medicine, Universitas Hasanuddin (No. 1009/UN4.6.4.5.31/PP36/2024) and conducted in accordance with the Declaration of Helsinki. All participants provided written informed consent prior to enrollment.
NOTE: This trial was retrospectively registered. The study was conducted from December 2024 to February 2025 and received ethical clearance prior to study initiation. Registration was performed after study completion due to the investigator's initial unawareness of prospective registration requirements. No outcome measures, study design, or statistical analysis plan were modified following data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This parallel-group RCT compared two arms over 6 weeks. Participants were randomly allocated in a 1:1 ratio using a simple random number generator by an independent researcher not involved in clinical recruitment.
| Arm | Type | Receives |
|---|---|---|
| Supportive Psychotherapy plus Risperidone | Experimental | Behavioral: Structured Supportive Psychotherapy, Drug: Risperidone 2 mgParticipants received risperidone 4 mg/day (2 mg tablet twice daily, oral administration) plus structured supportive psychotherapy consisting of 12 sessions delivered twice weekly over 6 weeks (15-30 minutes per session). Supportive psychotherapy was delivered using a validated module by the principal investigator. |
| Risperidone Monotherapy | Active comparator | Drug: Risperidone 2 mgParticipants received risperidone 4 mg/day (2 mg tablet twice daily, oral administration) monotherapy for 6 weeks without any structured psychotherapy intervention. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male patients diagnosed with schizophrenia according to DSM-5 criteria
- Aged 20-45 years
- Disease onset less than one year
- Insight level grade 4
- PANSS-EC score 14 or less
Key exclusion criteria (7 listed)
- Organic comorbid diseases
- History of substance abuse within previous six months except caffeine and nicotine
- Comorbid personality disorders
- Obesity
- Active infectious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Supportive PsychotherapyStructured supportive psychotherapy using the Supportive Psychotherapy Module for Schizophrenia (Suhuyanli et al.), nationally validated in the Indonesian population. Consisting of 12 structured sessions delivered twice weekly over 6 weeks (15-30 minutes per session), organized into initial (sessions 1-3), middle (sessions 4-9), and termination phases (sessions 10-12). Sessions were delivered by three trained psychiatrists supervised by a consultant in medical psychotherapy. To minimize expectation bias, the intervention was described to all participants as "standard supportive counseling." | Behavioural | Supportive Psychotherapy plus Risperidone |
| Risperidone 2 mgRisperidone 4 mg/day (2 mg tablet twice daily, oral administration) for 6 weeks. Administered to both the intervention group (in combination with supportive psychotherapy) and the control group (as monotherapy). | Drug | Risperidone Monotherapy, Supportive Psychotherapy plus Risperidone |
Primary outcome
Change in Cognitive Function (MoCA-Ina Score)
Time frame: Baseline (Week 0) and post-intervention (Week 6)
Change in cognitive function assessed by the Montreal Cognitive Assessment - Indonesian version (MoCA-Ina) from baseline to Week 6. Score range 0-30; higher scores indicate better cognitive function. Inter-rater reliability kappa=0.820.
Change in Serum hs-CRP Level
Time frame: Baseline (Week 0) and post-intervention (Week 6)
Change in serum high-sensitivity C-reactive protein (hs-CRP) level from baseline to Week 6, measured by Sandwich-ELISA (Elabscience Human hs-CRP ELISA Kit, Cat. No. E-EL-H5134; detection range 15.63-1000 pg/mL; sensitivity 9.38 pg/mL).
1 secondary outcome
Correlation Between Delta hs-CRP and Delta MoCA-Ina
Time frame: Week 6 (end of intervention)
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 17 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Agus Durman, MD principal investigator
Department of Psychiatry, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, Indonesia
Indrawaty Suhuyanli, MD study chair
Department of Psychiatry, Faculty of Medicine, Hasanuddin University, Makassar, South Sulawesi, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Structured Supportive Psychotherapy and Risperidone 2 mg in people with Schizophrenia and Cognitive Dysfunction, run by Hasanuddin University at 1 site in Indonesia.
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 10 inclusion and 7 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 17 Mar 2026. 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 Indonesia. 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.
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?
Change in Cognitive Function (MoCA-Ina Score) (time frame: Baseline (Week 0) and post-intervention (Week 6)). 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?
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 17 Mar 2026.