NCT00564564

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

November 26, 2007

Last Update Submit

October 25, 2017

Conditions

Obsessive Compulsive Disorder

Keywords

obsessive compulsive disorderpharmacological treatmentquetiapineclomipramineSSRI

Outcome Measures

Primary Outcomes (1)

  • YBOCS

    difference between initial and final (12 week) Yale Brown Obsessive Compulsive Scale (YBOCS)score

    12 weeks

Secondary Outcomes (3)

  • CGI

    12 weeks

  • Tolerability

    weeks 0,2,4,8 and 12

  • Cardiotoxicity

    week 0 and 2

Study Arms (2)

Quetiapine augmentation

EXPERIMENTAL

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

Drug: Quetiapine

Clomipramine augmentation

ACTIVE COMPARATOR

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

Drug: Clomipramine

Interventions

QuetiapineDRUG

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)

Also known as: Seroquel
Quetiapine augmentation
ClomipramineDRUG

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)

Also known as: Anafranil
Clomipramine augmentation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 16585942BACKGROUND

  • 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.

    PMID: 8518974BACKGROUND

  • 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.

    PMID: 15323587BACKGROUND

  • 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.

    PMID: 15933483BACKGROUND

  • 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.

    PMID: 10572334BACKGROUND

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Quetiapine FumarateClomipramine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDibenzazepines

Study Officials

  • Juliana B Diniz, MD

    Department of Psychiatry University of São Paulo Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 26, 2007

First Posted

November 28, 2007

Study Start

January 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations

BR(1)