NCT00466609

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2007

Typical duration for phase_4

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

First Submitted

Initial submission to the registry

April 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

2.8 years

First QC Date

April 26, 2007

Last Update Submit

October 26, 2017

Conditions

Obsessive Compulsive Disorder

Keywords

clomipraminequetiapinefluoxetineplaceboaugmentationobsessive compulsive disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • QoL

    12 weeks

  • Social Adaptation

    12 weeks

  • Tolerability

    weeks 0,1,2,3,4,8,12

  • BDI

    12 weeks

  • BAI

    12 weeks

  • +3 more secondary outcomes

Study Arms (3)

Quetiapine (fluoxetine plus quetiapine)

EXPERIMENTAL

fluoxetine up to 40mg once a day plus Quetiapine up to 200mg once a day, during 12 weeks

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

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

Drug: Placebo (fluoxetine plus placebo)

Interventions

Clomipramine (fluoxetine plus clomipramine)DRUG

Clomipramine at maximum dosage of 75mg per day plus fluoxetine at maximum dosage of 40mg per day

Also known as: Anafranil
Clomipramine (fluoxetine plus clomipramine)
Quetiapine (fluoxetine plus quetiapine)DRUG

Quetiapine at maximum tolerated dosage of 200mg per day plus fluoxetine at maximum dosage of 40mg per day

Also known as: Seroquel
Quetiapine (fluoxetine plus quetiapine)
Placebo (fluoxetine plus placebo)DRUG

Placebo plus fluoxetine at maximum dosage of 80mg per day

Also known as: Prozac, Daforin (EMS pharmaceutics)
Placebo (fluoxetine plus placebo)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Psychiatry

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 22020357DERIVED

  • 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.

    PMID: 19578654DERIVED

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

ClomipramineFluoxetineQuetiapine Fumarate

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPropylaminesAminesOrganic ChemicalsDibenzothiazepinesThiazepinesThiepinsSulfur Compounds

Study Officials

  • Juliana B Diniz, MD

    University of Sao Paulo Medical School

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 26, 2007

First Posted

April 27, 2007

Study Start

May 1, 2007

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

October 30, 2017

Record last verified: 2017-10

Locations

BR(1)