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| ID | Type | Description | Link |
|---|---|---|---|
| 2005/55628-08 | Other Grant/Funding Number | FAPESP |
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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine augmentation | Experimental | Quetiapine up to 200mg/day plus SSRI at maximum tolerated or recommended dosage |
|
| Clomipramine augmentation | Active Comparator | Clomipramine up to 150mg/day plus SSRI at maximum tolerated or recommended dosage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| YBOCS | difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CGI | Clinical Global Impression score for improvement at week 12 | 12 weeks |
| Tolerability | adverse events measure (emphasis in serotonergic syndrome) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juliana B Diniz, MD | Department of Psychiatry University of São Paulo Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School | São Paulo | São Paulo | 05403-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16585942 | Background | 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. | |
| 8518974 | Background | Browne 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. |
| Label | URL |
|---|---|
| institutional site | View source |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D002997 | Clomipramine |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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|
| Clomipramine | Drug | 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) |
|
|
| weeks 0,2,4,8 and 12 |
| Cardiotoxicity | Changes in baseline (week 0) EKG regarding QT interval | week 0 and 2 |
| 15323587 | Background | Denys 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. |
| 15933483 | Background | Fineberg 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. |
| 10572334 | Background | Pallanti 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. |
| Mains results | View source |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003984 | Dibenzazepines |