Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005/55628-08 | Other Grant/Funding Number | FAPESP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| FundaĆ§Ć£o de Amparo Ć Pesquisa do Estado de SĆ£o Paulo | OTHER_GOV |
| Conselho Nacional de Desenvolvimento CientĆfico e TecnolĆ³gico | OTHER_GOV |
| Novartis | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine (fluoxetine plus quetiapine) | Experimental | fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks |
|
| Clomipramine (fluoxetine plus clomipramine) | Active Comparator | Fluoxetine up to 40mg once a day plus clomipramine up to 75mg once a day, during 12 weeks |
|
| Placebo (fluoxetine plus placebo) | Placebo Comparator | Fluoxetine up to 80 mg once a day plus placebo 3 pills once a day, during 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clomipramine (fluoxetine plus clomipramine) | Drug | Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| QoL | Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12. | 12 weeks |
| Social Adaptation | Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman & Payket, 1974) administered on weeks 0 and 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juliana B Diniz, MD | University of Sao Paulo Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Psychiatry | SĆ£o Paulo | SĆ£o Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22020357 | Derived | 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. | |
| 19578654 | Derived |
| Label | URL |
|---|---|
| Institutional site of main sponsor | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Quetiapine (fluoxetine plus quetiapine) | Drug | Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day |
|
|
| Placebo (fluoxetine plus placebo) | Drug | Placebo plus fluoxetine at maximum dosage of 80mg per day |
|
|
| 12 weeks |
| Tolerability | Tolerability of the proposed treatments through adverse events follow-up performed each visit (emphasis in serotonergic syndrome) | weeks 0,1,2,3,4,8,12 |
| BDI | Score obtained with Beck depression inventory (BDI) | 12 weeks |
| BAI | Score obtained with BeckĀ“s anxiety inventory (BAI) | 12 weeks |
| CGI | Clinical global impression measure of improvement | 12 weeks |
| Cardiotoxicity | Change from baseline EKG regarding QT interval | 2 weeks |
| Plasma levels | Fluoxetine dosage and Clomipramine plasmatic dosages (when applies) | weeks 2 and 12 |
| Fossaluza 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. |
| Main results | View source |
| Secondary analysis results | View source |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002997 | Clomipramine |
| D005473 | Fluoxetine |
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
Not provided
Not provided