Obsessive Compulsive DisorderPhase 4EPMTOCNCT00466609
Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment
A Phase 4 study testing Clomipramine (fluoxetine plus clomipramine) and Quetiapine (fluoxetine plus quetiapine) in people with Obsessive Compulsive Disorder, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for obsessive compulsive disorder patients non-respondent to first line pharmacological treatment. 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?
- Clomipramine (fluoxetine plus clomipramine) and Quetiapine (fluoxetine plus quetiapine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- May 2007to Apr 2010
- 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
- OCD diagnosis
- YBOCS score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions)
- Previously signed informed consent to participate in this clinical trial
Who cannot join
- Patients with 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
- Current pregnancy or intention to get pregnant before the end of the treatment protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study
This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for obsessive compulsive disorder patients non-respondent to first line pharmacological treatment. The investigators will compare: fluoxetine maintenance at maximum dosage for additional 12 weeks; the association of fluoxetine with quetiapine; and the association of fluoxetine with clomipramine.
Read the detailed description
Arm 1: SSRI (Fluoxetine 40mg* once a day) + Clomipramine 75mg* once a day.
Arm 2: SSRI (Fluoxetine 40mg* once a day) + Quetiapine 200mg* once a day.
Arm 3: SSRI (Fluoxetine 80mg* once a day) + Placebo once a day.
*or maximum tolerated dose
We hypothesize that quetiapine and clomipramine will be effective augmentation strategies for resistant OCD patients in comparison to placebo.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Clomipramine (fluoxetine plus clomipramine), Quetiapine (fluoxetine plus quetiapine), Placebo (fluoxetine plus placebo)
- Keywords
- clomipramine, quetiapine, fluoxetine, placebo, augmentation, obsessive compulsive disorder
- 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.
Clomipramine (fluoxetine plus clomipramine)Drug
Also called Anafranil
Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day
Quetiapine (fluoxetine plus quetiapine)Drug
Also called Seroquel
Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day
Placebo (fluoxetine plus placebo)Drug
Also called Prozac, Daforin (EMS pharmaceutics)
Placebo plus fluoxetine at maximum dosage of 80mg per day
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine (fluoxetine plus quetiapine) | Experimental | fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks Receives: Drug: Quetiapine (fluoxetine plus quetiapine) |
| Clomipramine (fluoxetine plus clomipramine) | Active comparator | Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks Receives: Drug: Clomipramine (fluoxetine plus clomipramine) |
| Placebo (fluoxetine plus placebo) | Placebo comparator | Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 weeks Receives: Drug: Placebo (fluoxetine plus placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
YBOCS
Rates of improvement after 12 weeks of treatment based on the difference of initial and final Yale Brown Obsessive Compulsive Scale (YBOCS) scores for obsessions and compulsions
Measured: 12 weeks
Secondary outcomes (8)
QoL
Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12.
Measured: 12 weeks
Social Adaptation
Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman \& Payket, 1974) administered on weeks 0 and 12
Measured: 12 weeks
Tolerability
Tolerability of the proposed treatments through adverse events follow-up performed each visit (emphasis in serotonergic syndrome)
Measured: weeks 0,1,2,3,4,8,12
BDI
Score obtained with Beck depression inventory (BDI)
Measured: 12 weeks
BAI
Score obtained with Beck´s anxiety inventory (BAI)
Measured: 12 weeks
CGI
Clinical global impression measure of improvement
Measured: 12 weeks
Cardiotoxicity
Change from baseline EKG regarding QT interval
Measured: 2 weeks
Plasma levels
Fluoxetine dosage and Clomipramine plasmatic dosages (when applies)
Measured: weeks 2 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionMar 2010
- Study completionApr 2010
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Novartis
- Responsible party
- Principal investigator, Juliana Belo Diniz, University of Sao Paulo
- Investigators
- Juliana B Diniz, MD, Principal investigator, University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466609
- Sponsor's protocol ID
- 05/55628-8
- Other IDs
- 2005/55628-08, 2005
- Acronym
- EPMTOC
- Status last verified
- Oct 2017
- First submitted
- 26 Apr 2007
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diniz JB, Shavitt RG, Fossaluza V, Koran L, Pereira CA, Miguel EC. A double-blind, randomized, controlled trial of fluoxetine plus quetiapine or clomipramine versus fluoxetine plus placebo for obsessive-compulsive disorder. J Clin Psychopharmacol. 2011 Dec;31(6):763-8. doi: 10.1097/JCP.0b013e3182367aee.
PubMed 22020357Fossaluza V, Diniz JB, Pereira Bde B, Miguel EC, Pereira CA. Sequential allocation to balance prognostic factors in a psychiatric clinical trial. Clinics (Sao Paulo). 2009;64(6):511-8. doi: 10.1590/s1807-59322009000600005.
PubMed 19578654
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT00466609
- Acronym / sponsor ID
- EPMTOC / 05/55628-8
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- clomipramine, quetiapine, fluoxetine, placebo, augmentation, obsessive compulsive disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Novartis
- Study start
- May 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 27 Apr 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.
This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for obsessive compulsive disorder patients non-respondent to first line pharmacological treatment. The investigators will compare: fluoxetine maintenance at maximum dosage for additional 12 weeks; the association of fluoxetine with quetiapine; and the association of fluoxetine with clomipramine.
Detailed description
Arm 1: SSRI (Fluoxetine 40mg* once a day) + Clomipramine 75mg* once a day.
Arm 2: SSRI (Fluoxetine 40mg* once a day) + Quetiapine 200mg* once a day.
Arm 3: SSRI (Fluoxetine 80mg* once a day) + Placebo once a day.
*or maximum tolerated dose
We hypothesize that quetiapine and clomipramine will be effective augmentation strategies for resistant OCD patients in comparison to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quetiapine (fluoxetine plus quetiapine) | Experimental | Drug: Quetiapine (fluoxetine plus quetiapine)fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks |
| Clomipramine (fluoxetine plus clomipramine) | Active comparator | Drug: Clomipramine (fluoxetine plus clomipramine)Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks |
| Placebo (fluoxetine plus placebo) | Placebo comparator | Drug: Placebo (fluoxetine plus placebo)Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- OCD diagnosis
- YBOCS score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions)
- Previously signed informed consent to participate in this clinical trial
Key exclusion criteria (5 listed)
- Patients with 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
- 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 |
|---|---|---|
| Clomipramine (fluoxetine plus clomipramine)Also: AnafranilClomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day | Drug | Clomipramine (fluoxetine plus clomipramine) |
| Quetiapine (fluoxetine plus quetiapine)Also: SeroquelQuetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day | Drug | Quetiapine (fluoxetine plus quetiapine) |
| Placebo (fluoxetine plus placebo)Also: Prozac, Daforin (EMS pharmaceutics)Placebo plus fluoxetine at maximum dosage of 80mg per day | Drug | Placebo (fluoxetine plus placebo) |
Primary outcome
YBOCS
Time frame: 12 weeks
Rates of improvement after 12 weeks of treatment based on the difference of initial and final Yale Brown Obsessive Compulsive Scale (YBOCS) scores for obsessions and compulsions
8 secondary outcomes
QoL
Time frame: 12 weeks
Social Adaptation
Time frame: 12 weeks
Tolerability
Time frame: weeks 0,1,2,3,4,8,12
BDI
Time frame: 12 weeks
BAI
Time frame: 12 weeks
CGI
Time frame: 12 weeks
Cardiotoxicity
Time frame: 2 weeks
Plasma levels
Time frame: weeks 2 and 12
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 30 Oct 2017.
- Derived from this study: PubMed 22020357Diniz JB, Shavitt RG, Fossaluza V, Koran L, Pereira CA, Miguel EC. A double-blind, randomized, controlled trial of fluoxetine plus quetiapine or clomipramine versus fluoxetine plus placebo for obsessive-compulsive disorder. J Clin Psychopharmacol. 2011 Dec;31(6):763-8. doi: 10.1097/JCP.0b013e3182367aee.
- Derived from this study: PubMed 19578654Fossaluza V, Diniz JB, Pereira Bde B, Miguel EC, Pereira CA. Sequential allocation to balance prognostic factors in a psychiatric clinical trial. Clinics (Sao Paulo). 2009;64(6):511-8. doi: 10.1590/s1807-59322009000600005.
- Institutional site of main sponsorLink provided by the sponsor.
- Main resultsLink provided by the sponsor.
- Secondary analysis 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
University of Sao 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 Clomipramine (fluoxetine plus clomipramine) and Quetiapine (fluoxetine plus quetiapine) 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 30 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. 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?
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 NCT00466609, 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 30 Oct 2017.