Obsessive Compulsive DisorderPhase 4QCATNCT00564564
Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-compulsive Disorder Patients
A Phase 4 study testing Quetiapine and Clomipramine in people with Obsessive Compulsive Disorder, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The objective of this trial is to compare in an open trial format the efficacy of association of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete remission of obsessive compulsive disorder symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Quetiapine and Clomipramine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2006to Dec 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary OCD diagnosis according to DSM IV criteria
- current symptoms were responsible for significant distress
- previous trial of at least 12 weeks with SSRI (being at least 8 weeks at maximum tolerated dosage) failed to produce full remission of OCD symptoms
Who cannot join
- presence of clinical or neurological diseases that may be worsen by the medications included in treatment protocol
- current substance dependence or abuse,
- current psychotic symptoms
- current suicide risk
- and current pregnancy or intention to get pregnant before the end of the treatment protocol
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School
São Paulo, São Paulo, 05403-010
About this study
Official title: Quetiapine Augmentation Versus Clomipramine Augmentation of Selective Serotonin Reuptake Inhibitors for Obsessive-compulsive Disorder Patients That do Not Respond to a SSRI Trial: a Randomized Open-trial.
The objective of this trial is to compare in an open trial format the efficacy of association of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete remission of obsessive compulsive disorder symptoms.
Read the detailed description
The objective of this trial wis to compare in an randomized open trial format the efficacy of association of clomipramine at maximum dosage of 75mg per day and quetiapine at maximum dosage of 200mg per day with SSRI after SSRI treatment for 12 weeks failed to produce complete remission of OCD symptoms.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Quetiapine, Clomipramine
- Keywords
- obsessive compulsive disorder, pharmacological treatment, quetiapine, clomipramine, SSRI
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Also called Seroquel
Quetiapine once a day at maximum dosage of 200mg per day asociated to a SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram)
ClomipramineDrug
Also called Anafranil
Clomipramine once a day at maximum dosage of 75mg per day plus SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram)
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine augmentation | Experimental | Quetiapine up to 200mg/day plus SSRI at maximum tolerated or recommended dosage Receives: Drug: Quetiapine |
| Clomipramine augmentation | Active comparator | Clomipramine up to 150mg/day plus SSRI at maximum tolerated or recommended dosage Receives: Drug: Clomipramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
YBOCS
difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score
Measured: 12 weeks
Secondary outcomes (3)
CGI
Clinical Global Impression score for improvement at week 12
Measured: 12 weeks
Tolerability
adverse events measure (emphasis in serotonergic syndrome)
Measured: weeks 0,2,4,8 and 12
Cardiotoxicity
Changes in baseline (week 0) EKG regarding QT interval
Measured: week 0 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2007 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Juliana Belo Diniz, University of Sao Paulo
- Investigators
- Juliana B Diniz, MD, Principal investigator, Department of Psychiatry University of São Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564564
- Sponsor's protocol ID
- 968/05
- Other IDs
- 2005/55628-08, 2005
- Acronym
- QCAT
- Status last verified
- Oct 2017
- First submitted
- 26 Nov 2007
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bloch MH, Landeros-Weisenberger A, Kelmendi B, Coric V, Bracken MB, Leckman JF. A systematic review: antipsychotic augmentation with treatment refractory obsessive-compulsive disorder. Mol Psychiatry. 2006 Jul;11(7):622-32. doi: 10.1038/sj.mp.4001823. Epub 2006 Apr 4.
PubMed 16585942Browne M, Horn E, Jones TT. The benefits of clomipramine-fluoxetine combination in obsessive compulsive disorder. Can J Psychiatry. 1993 May;38(4):242-3. doi: 10.1177/070674379303800402.
PubMed 8518974Denys D, de Geus F, van Megen HJ, Westenberg HG. A double-blind, randomized, placebo-controlled trial of quetiapine addition in patients with obsessive-compulsive disorder refractory to serotonin reuptake inhibitors. J Clin Psychiatry. 2004 Aug;65(8):1040-8. doi: 10.4088/jcp.v65n0803.
PubMed 15323587Fineberg NA, Sivakumaran T, Roberts A, Gale T. Adding quetiapine to SRI in treatment-resistant obsessive-compulsive disorder: a randomized controlled treatment study. Int Clin Psychopharmacol. 2005 Jul;20(4):223-6. doi: 10.1097/00004850-200507000-00005.
PubMed 15933483Pallanti S, Quercioli L, Paiva RS, Koran LM. Citalopram for treatment-resistant obsessive-compulsive disorder. Eur Psychiatry. 1999 Apr;14(2):101-6. doi: 10.1016/s0924-9338(99)80725-1.
PubMed 10572334
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quetiapine Augmentation Versus Clomipramine Augmentation of Selective Serotonin Reuptake Inhibitors for Obsessive-compulsive Disorder Patients That do Not Respond to a SSRI Trial: a Randomized Open-trial.
- ClinicalTrials.gov ID
- NCT00564564
- Acronym / sponsor ID
- QCAT / 968/05
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- obsessive compulsive disorder, pharmacological treatment, quetiapine, clomipramine, SSRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Nov 2007 (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.
The objective of this trial is to compare in an open trial format the efficacy of association of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete remission of obsessive compulsive disorder symptoms.
Detailed description
The objective of this trial wis to compare in an randomized open trial format the efficacy of association of clomipramine at maximum dosage of 75mg per day and quetiapine at maximum dosage of 200mg per day with SSRI after SSRI treatment for 12 weeks failed to produce complete remission of OCD symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine augmentation | Experimental | Drug: QuetiapineQuetiapine up to 200mg/day plus SSRI at maximum tolerated or recommended dosage |
| Clomipramine augmentation | Active comparator | Drug: ClomipramineClomipramine up to 150mg/day plus SSRI at maximum tolerated or recommended dosage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary OCD diagnosis according to DSM IV criteria
- current symptoms were responsible for significant distress
- previous trial of at least 12 weeks with SSRI (being at least 8 weeks at maximum tolerated dosage) failed to produce full remission of OCD symptoms
Key exclusion criteria (5 listed)
- presence of clinical or neurological diseases that may be worsen by the medications included in treatment protocol
- current substance dependence or abuse,
- current psychotic symptoms
- current suicide risk
- and current pregnancy or intention to get pregnant before the end of the treatment protocol
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 |
|---|---|---|
| QuetiapineAlso: SeroquelQuetiapine once a day at maximum dosage of 200mg per day asociated to a SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram) | Drug | Quetiapine augmentation |
| ClomipramineAlso: AnafranilClomipramine once a day at maximum dosage of 75mg per day plus SSRI (maximum dosage of 40mg per day for fluoxetine; 200mg per day for sertraline and 60mg per day for citalopram) | Drug | Clomipramine augmentation |
Primary outcome
YBOCS
Time frame: 12 weeks
difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score
3 secondary outcomes
CGI
Time frame: 12 weeks
Tolerability
Time frame: weeks 0,2,4,8 and 12
Cardiotoxicity
Time frame: week 0 and 2
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 27 Oct 2017.
- Background: PubMed 16585942Bloch MH, Landeros-Weisenberger A, Kelmendi B, Coric V, Bracken MB, Leckman JF. A systematic review: antipsychotic augmentation with treatment refractory obsessive-compulsive disorder. Mol Psychiatry. 2006 Jul;11(7):622-32. doi: 10.1038/sj.mp.4001823. Epub 2006 Apr 4.
- Background: PubMed 8518974Browne M, Horn E, Jones TT. The benefits of clomipramine-fluoxetine combination in obsessive compulsive disorder. Can J Psychiatry. 1993 May;38(4):242-3. doi: 10.1177/070674379303800402.
- Background: PubMed 15323587Denys D, de Geus F, van Megen HJ, Westenberg HG. A double-blind, randomized, placebo-controlled trial of quetiapine addition in patients with obsessive-compulsive disorder refractory to serotonin reuptake inhibitors. J Clin Psychiatry. 2004 Aug;65(8):1040-8. doi: 10.4088/jcp.v65n0803.
- Background: PubMed 15933483Fineberg NA, Sivakumaran T, Roberts A, Gale T. Adding quetiapine to SRI in treatment-resistant obsessive-compulsive disorder: a randomized controlled treatment study. Int Clin Psychopharmacol. 2005 Jul;20(4):223-6. doi: 10.1097/00004850-200507000-00005.
- Background: PubMed 10572334Pallanti S, Quercioli L, Paiva RS, Koran LM. Citalopram for treatment-resistant obsessive-compulsive disorder. Eur Psychiatry. 1999 Apr;14(2):101-6. doi: 10.1016/s0924-9338(99)80725-1.
- institutional siteLink provided by the sponsor.
- Mains resultsLink provided by the sponsor.
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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.
Juliana B Diniz, MD principal investigator
Department of Psychiatry University of São Paulo Medical School
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 Quetiapine and Clomipramine in people with Obsessive Compulsive Disorder, run by University of Sao Paulo at 1 site in Brazil.
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 3 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 27 Oct 2017. 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 Brazil. 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 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?
YBOCS (time frame: 12 weeks). 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 NCT00564564, which also lists 5 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 27 Oct 2017.