SchizophreniaPhase 4RECOVERY2NCT01263080
Evaluation of Mirtazapine and Folic Acid for Schizophrenia:
A Phase 4 study testing mirtazapine and folic acid in people with Schizophrenia, run by Capital Medical University at 1 site in China.
Trial summary
Multicentre randomised double-blind, placebo-controlled 2x2 factorial trial investigating the effects of adding mirtazapine and folic acid to existing therapy for patients with schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- mirtazapine and folic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Dec 2012
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients or outpatients age 18 to 70 years;
- Meet DSM-IV criteria for schizophrenia;
- Signed an informed consent form by patients or their legally acceptable representatives;
- PANSS total score >=60 and at least one item of P1, P2, P3, P5 or P6 >=4 to ensure subject has current active psychotic symptoms - i.e. hallucinations, delusions, thought disorder;
- Subjects who are currently taking effective dose of antipsychotic;
- Women must agree to practice an effective method of birth control if they are sexually active before entry and throughout the study.
Who cannot join
- Meet any other DSM-IV Axis I disorders;
- Meet DSM-IV criteria for substance abuse or dependence;
- Have been treatment-resistant to 2 or more kinds of antipsychotics with sufficient dosage for at least 4 weeks, or require clozapine treatment, or have received clozapine treatment within 1 month prior to randomization;
- Subjects are actively suicidal or judged clinically to be at risk of serious suicidal or violent behavior in the opinion of the investigator;
- Have serious or unstable medical illness (e.g., cardiovascular disease, neurologic, hematologic, renal, hepatic, immunologic, endocrine, or other systemic illness), or have any clinically significant abnormality on laboratory test or ECG which indicate severe medical conditions;
- Have received electroconvulsive therapy within 28 days before randomization;
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- Have received long acting antipsychotic within 1 treatment cycle before randomization;
- Have received antidepressant within 14 days, or have received MAOIs within 4 weeks before randomization or require antidepressive treatment;
- History of prostatic hypertrophy or dysuria;
- History of narrow-angle glaucoma or elevation of intraocular pressure;
- Known or suspected history of allergy or have contradiction to mirtazapine or folic acid;
- Known have currently requirement of taking mirtazapine or folic acid;
- Women who are pregnant or nursing;
- Have previously completed or withdrawn from this study, or participated in a clinical trial of another drug within 30 days.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anding Hospital, Capital Medical University
Beijing, Beijing Municipality, 100088
About this study
Official title: Multicentre Randomised Double-blind, Placebo-controlled 2x2 Factorial Trial Investigating the Effects of Adding Mirtazapine and Folic Acid to Existing Therapy for Patients With Schizophrenia
Multicentre randomised double-blind, placebo-controlled 2x2 factorial trial investigating the effects of adding mirtazapine and folic acid to existing therapy for patients with schizophrenia
Read the detailed description
The combination of mirtazapine plus antipsychotic potentially offers considerable benefit for patients with schizophrenia. Folic acid is a promising adjunctive therapy for schizophrenia that may also provide benefits for patients with other mental disorders. Furthermore the effects of folic acid may be affected by genotype.
The trial will investigate the effects of adding mirtazapine and the effects of adding folic acid to treatments for schizophrenia. At randomisation, patients will be separately randomised to mirtazapine or placebo and to folic acid or placebo.
Randomised, double-blind, placebo-controlled 2x2 factorial trial with 12-week follow-up.
- Conditions
- Schizophrenia
- Being tested
- mirtazapine, folic acid placebo, mirtazapine placebo, folic acid
- Keywords
- mirtazapine, folic acid, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirtazapineDrug
Also called Remeron
mirtazapine 30mg QD
folic acid placeboDrug
Also called Folic placebo
folic acid placebo 1 tablet QD
mirtazapine placeboDrug
Also called Remeron placebo
mirtazapine placebo 1 tablet QD
folic acidDrug
Also called vitamin B 9
folic acid 0.4mg QD
| Study group | Role | What they receive |
|---|---|---|
| mirtazapine+folic acid | Active comparator | mirtazapine 30mg QD, folic acid 0.4mg QD Receives: Drug: mirtazapine; Drug: folic acid |
| mirtazapine+folic acid placebo | Active comparator | mirtazapine 30mg QD, folic acid placebo 1 tablet QD Receives: Drug: mirtazapine; Drug: folic acid placebo |
| mirtazapine placebo+folic acid | Active comparator | mirtazapine placebo 1 tablet QD, folic acid 0.4mg QD Receives: Drug: mirtazapine placebo; Drug: folic acid |
| mirtazapine placebo+folic acid placebo | Placebo comparator | mirtazapine placebo 1 tablet QD, folic acid placebo 1 tablet QD Receives: Drug: folic acid placebo; Drug: mirtazapine placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of mirtazapine and placebo for treatment of symptoms associated with schizophrenia
Measured: baseline, week4, week8, week12
Secondary outcomes (5)
To compare the efficacy of folic acid and placebo for treatment of symptoms of schizophrenia
Measured: baseline, week4, week8, week12
To compare the efficacy of mirtazapine and placebo for treatment of negative symptoms of schizophrenia
Measured: baseline, week4, week8, week12
To compare the efficacy of folic acid and placebo for treatment of negative symptoms of schizophrenia
Measured: baseline, week4, week8, week12
To compare the safety and tolerability of mirtazapine and placebo in patients with schizophrenia
Measured: baseline, week4, week8, week12
To compare the safety and tolerability of folic acid and placebo in patients with schizophrenia
Measured: baseline, week4, week8, week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2012
- Study completionDec 2012
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.
- More trials run by Capital Medical UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Wang, Capital Medical University
- Investigators
- Gang Wang, M.D., Principal investigator, Beijing Anding Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263080
- Sponsor's protocol ID
- RECOVERY2
- Acronym
- RECOVERY2
- Status last verified
- Aug 2016
- First submitted
- 17 Dec 2010
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomised Double-blind, Placebo-controlled 2x2 Factorial Trial Investigating the Effects of Adding Mirtazapine and Folic Acid to Existing Therapy for Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01263080
- Acronym / sponsor ID
- RECOVERY2 / RECOVERY2
- Conditions
- Schizophrenia
- Keywords
- mirtazapine, folic acid, schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Dec 2010 (estimated)
- 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.
Multicentre randomised double-blind, placebo-controlled 2x2 factorial trial investigating the effects of adding mirtazapine and folic acid to existing therapy for patients with schizophrenia
Detailed description
The combination of mirtazapine plus antipsychotic potentially offers considerable benefit for patients with schizophrenia. Folic acid is a promising adjunctive therapy for schizophrenia that may also provide benefits for patients with other mental disorders. Furthermore the effects of folic acid may be affected by genotype.
The trial will investigate the effects of adding mirtazapine and the effects of adding folic acid to treatments for schizophrenia. At randomisation, patients will be separately randomised to mirtazapine or placebo and to folic acid or placebo.
Randomised, double-blind, placebo-controlled 2x2 factorial trial with 12-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mirtazapine+folic acid | Active comparator | Drug: mirtazapine, Drug: folic acidmirtazapine 30mg QD, folic acid 0.4mg QD |
| mirtazapine+folic acid placebo | Active comparator | Drug: mirtazapine, Drug: folic acid placebomirtazapine 30mg QD, folic acid placebo 1 tablet QD |
| mirtazapine placebo+folic acid | Active comparator | Drug: mirtazapine placebo, Drug: folic acidmirtazapine placebo 1 tablet QD, folic acid 0.4mg QD |
| mirtazapine placebo+folic acid placebo | Placebo comparator | Drug: folic acid placebo, Drug: mirtazapine placebomirtazapine placebo 1 tablet QD, folic acid placebo 1 tablet QD |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Inpatients or outpatients age 18 to 70 years;
- Meet DSM-IV criteria for schizophrenia;
- Signed an informed consent form by patients or their legally acceptable representatives;
- PANSS total score >=60 and at least one item of P1, P2, P3, P5 or P6 >=4 to ensure subject has current active psychotic symptoms - i.e. hallucinations, delusions, thought disorder;
- Subjects who are currently taking effective dose of antipsychotic;
Key exclusion criteria (14 listed)
- Meet any other DSM-IV Axis I disorders;
- Meet DSM-IV criteria for substance abuse or dependence;
- Have been treatment-resistant to 2 or more kinds of antipsychotics with sufficient dosage for at least 4 weeks, or require clozapine treatment, or have received clozapine treatment within 1 month prior to randomization;
- Subjects are actively suicidal or judged clinically to be at risk of serious suicidal or violent behavior in the opinion of the investigator;
- Have serious or unstable medical illness (e.g., cardiovascular disease, neurologic, hematologic, renal, hepatic, immunologic, endocrine, or other systemic illness), or have any clinically significant abnormality on laboratory test or ECG which indicate severe medical conditions;
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 |
|---|---|---|
| mirtazapineAlso: Remeronmirtazapine 30mg QD | Drug | mirtazapine+folic acid, mirtazapine+folic acid placebo |
| folic acid placeboAlso: Folic placebofolic acid placebo 1 tablet QD | Drug | mirtazapine placebo+folic acid placebo, mirtazapine+folic acid placebo |
| mirtazapine placeboAlso: Remeron placebomirtazapine placebo 1 tablet QD | Drug | mirtazapine placebo+folic acid, mirtazapine placebo+folic acid placebo |
| folic acidAlso: vitamin B 9folic acid 0.4mg QD | Drug | mirtazapine placebo+folic acid, mirtazapine+folic acid |
Primary outcome
To compare the efficacy of mirtazapine and placebo for treatment of symptoms associated with schizophrenia
Time frame: baseline, week4, week8, week12
5 secondary outcomes
To compare the efficacy of folic acid and placebo for treatment of symptoms of schizophrenia
Time frame: baseline, week4, week8, week12
To compare the efficacy of mirtazapine and placebo for treatment of negative symptoms of schizophrenia
Time frame: baseline, week4, week8, week12
To compare the efficacy of folic acid and placebo for treatment of negative symptoms of schizophrenia
Time frame: baseline, week4, week8, week12
To compare the safety and tolerability of mirtazapine and placebo in patients with schizophrenia
Time frame: baseline, week4, week8, week12
To compare the safety and tolerability of folic acid and placebo in patients with schizophrenia
Time frame: baseline, week4, week8, week12
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 2 Aug 2016.
- 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.
Gang Wang, M.D. principal investigator
Beijing Anding Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mirtazapine and folic acid in people with Schizophrenia, run by Capital Medical University 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 6 inclusion and 14 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 2 Aug 2016. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To compare the efficacy of mirtazapine and placebo for treatment of symptoms associated with schizophrenia (time frame: baseline, week4, week8, week12). 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 2 Aug 2016.