SchizophreniaPhase 4NCT00169039
Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia
A Phase 4 study testing Clozapine and Chlorpromazine in people with Schizophrenia, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
Trial summary
This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Clozapine and Chlorpromazine
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1994to Feb 2002
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 19-60 years of age
- Diagnosis of schizophrenia
- BPRS score > 50
- Clinical Global Impressions rating > 4
- One of the following: BPRS items rated greater than or equal to 4, conceptual disorganization, suspiciousness, hallucinations, unusual thought content.
- At least 2 six-week trials of different neuroleptics given at a dosage equivalent to at least 600 mg per day of chlorpromazine OR at least 1 eight-week trial of a neuroleptic given at a dosage equivalent to at least 800 mg per day of chlorpromazine.
- The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent.
Who cannot join
- History of substance dependence within the past 2 months
- Major medical problems precluding the use of clozapine
- Pregnancy or lactation
- A serious suicide/homicide risk
Trial locations and contacts
1 site in 1 country.
United States1 site
Commonwealth Research Center
Jamaica Plain, Massachusetts, 02130
About this study
Official title: Clozapine Response and Biogenic Amines in Schizophrenia
This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.
Read the detailed description
This is a longitudinal double-blind 12-week study of the clinical and biochemical response to clozapine or chlorpromazine in a group of treatment-refractory schizophrenic patients.
The study has 4 phases: (1) A recruitment period; (2) a period of discontinuation of psychotropic medication; (3) a drug-washout period; and (4) a 12-week double-blind trial of clozapine or chlorpromazine.
- Conditions
- Schizophrenia
- Being tested
- Clozapine, Chlorpromazine
- Keywords
- Clozapine, Chlorpromazine, Schizophrenia, Biochemistry
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClozapineDrug
ChlorpromazineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical measures: Brief Psychiatric Rating Scale, Clinical Global Impression, Scale for the Assessment of Negative Symptoms, Simpson-Angus Scale, Abnormal Involuntary Movement Scale and Barnes Akathisia Scale.
Secondary outcomes (1)
Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 1994
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 66 participants
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Dartmouth-Hitchcock Medical Center, Commonwealth Research Center, Massachusetts, Novartis
- Responsible party
- Principal investigator, AlanGreen, Harvard Medical School (HMS and HSDM)
- Investigators
- Alan I Green, MD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169039
- Sponsor's protocol ID
- R01MH049891
- Other IDs
- R01MH049891
- Status last verified
- Apr 2015
- First submitted
- 10 Sep 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
Publications
Green AI, Alam MY, Boshes RA, Waternaux C, Pappalardo KM, Fitzgibbon ME, Tsuang MT, Schildkraut JJ. Haloperidol response and plasma catecholamines and their metabolites. Schizophr Res. 1993 Jun;10(1):33-7. doi: 10.1016/0920-9964(93)90074-s.
PubMed 8369230Green AI, Alam MY, Sobieraj JT, Pappalardo KM, Waternaux C, Salzman C, Schatzberg AF, Schildkraut JJ. Clozapine response and plasma catecholamines and their metabolites. Psychiatry Res. 1993 Feb;46(2):139-49. doi: 10.1016/0165-1781(93)90016-a.
PubMed 8483973
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clozapine Response and Biogenic Amines in Schizophrenia
- ClinicalTrials.gov ID
- NCT00169039
- Acronym / sponsor ID
- R01MH049891
- Conditions
- Schizophrenia
- Keywords
- Clozapine, Chlorpromazine, Schizophrenia, Biochemistry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 66 participants
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Dartmouth-Hitchcock Medical Center, Commonwealth Research Center, Massachusetts, Novartis
- Study start
- Dec 1994
- Study completion
- Feb 2002
- First posted
- 15 Sep 2005 (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.
This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.
Detailed description
This is a longitudinal double-blind 12-week study of the clinical and biochemical response to clozapine or chlorpromazine in a group of treatment-refractory schizophrenic patients.
The study has 4 phases: (1) A recruitment period; (2) a period of discontinuation of psychotropic medication; (3) a drug-washout period; and (4) a 12-week double-blind trial of clozapine or chlorpromazine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 19-60 years of age
- Diagnosis of schizophrenia
- BPRS score > 50
- Clinical Global Impressions rating > 4
- One of the following: BPRS items rated greater than or equal to 4, conceptual disorganization, suspiciousness, hallucinations, unusual thought content.
Key exclusion criteria (4 listed)
- History of substance dependence within the past 2 months
- Major medical problems precluding the use of clozapine
- Pregnancy or lactation
- A serious suicide/homicide risk
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 |
|---|---|---|
| Clozapine | Drug | – |
| Chlorpromazine | Drug | – |
Primary outcome
Clinical measures: Brief Psychiatric Rating Scale, Clinical Global Impression, Scale for the Assessment of Negative Symptoms, Simpson-Angus Scale, Abnormal Involuntary Movement Scale and Barnes Akathisia Scale.
1 secondary outcome
Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Background: PubMed 8369230Green AI, Alam MY, Boshes RA, Waternaux C, Pappalardo KM, Fitzgibbon ME, Tsuang MT, Schildkraut JJ. Haloperidol response and plasma catecholamines and their metabolites. Schizophr Res. 1993 Jun;10(1):33-7. doi: 10.1016/0920-9964(93)90074-s.
- Background: PubMed 8483973Green AI, Alam MY, Sobieraj JT, Pappalardo KM, Waternaux C, Salzman C, Schatzberg AF, Schildkraut JJ. Clozapine response and plasma catecholamines and their metabolites. Psychiatry Res. 1993 Feb;46(2):139-49. doi: 10.1016/0165-1781(93)90016-a.
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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.
Alan I Green, MD principal investigator
Harvard Medical School (HMS and HSDM)
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 Clozapine and Chlorpromazine in people with Schizophrenia, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 7 Apr 2015. 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 United States. 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 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 was stopped early. Results are not available in the source record.
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?
Clinical measures: Brief Psychiatric Rating Scale, Clinical Global Impression, Scale for the Assessment of Negative Symptoms, Simpson-Angus Scale, Abnormal Involuntary Movement Scale and Barnes Akathisia Scale.. 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 NCT00169039, which also lists 2 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 7 Apr 2015.