Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-compulsive Disorder Patients

NCT ID: NCT00564564

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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

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Obsessive Compulsive Disorder

Keywords

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obsessive compulsive disorder pharmacological treatment quetiapine clomipramine SSRI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Quetiapine augmentation

Quetiapine up to 200mg/day plus SSRI at maximum tolerated or recommended dosage

Group Type EXPERIMENTAL

Quetiapine

Intervention Type 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)

Clomipramine augmentation

Clomipramine up to 150mg/day plus SSRI at maximum tolerated or recommended dosage

Group Type ACTIVE_COMPARATOR

Clomipramine

Intervention Type 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)

Interventions

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Quetiapine

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)

Intervention Type DRUG

Clomipramine

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)

Intervention Type DRUG

Other Intervention Names

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Seroquel Anafranil

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Juliana Belo Diniz

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juliana B Diniz, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry University of São Paulo Medical School

Locations

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Institute of Psychiatry, Clinics Hospital, University of São Paulo Medical School

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 16585942 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8518974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15323587 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15933483 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10572334 (View on PubMed)

Related Links

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Other Identifiers

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2005/55628-08

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

968/05

Identifier Type: -

Identifier Source: org_study_id