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Completed

NCT Number: NCT00466609

Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment

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.

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Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Psychiatry

São Paulo, 05403-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Clomipramine (fluoxetine plus clomipramine)

Drug

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

Other names: Anafranil

Quetiapine (fluoxetine plus quetiapine)

Drug

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

Other names: Seroquel

Placebo (fluoxetine plus placebo)

Drug

Placebo plus fluoxetine at maximum dosage of 80mg per day

Other names: Prozac, Daforin (EMS pharmaceutics)

Primary outcomes

  1. YBOCS

    Time frame: 12 weeks

    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

Secondary outcomes

  1. QoL

    Time frame: 12 weeks

    Improvement of quality of life (QOL) will be assessed through SF-36 administered on weeks 0 and 12.

  2. Social Adaptation

    Time frame: 12 weeks

    Improvement of social adaptation using the Social Adaptation Scale (SAS) (Weissman & Payket, 1974) administered on weeks 0 and 12

  3. Tolerability

    Time frame: weeks 0,1,2,3,4,8,12

    Tolerability of the proposed treatments through adverse events follow-up performed each visit (emphasis in serotonergic syndrome)

  4. BDI

    Time frame: 12 weeks

    Score obtained with Beck depression inventory (BDI)

  5. BAI

    Time frame: 12 weeks

    Score obtained with Beck´s anxiety inventory (BAI)

  6. CGI

    Time frame: 12 weeks

    Clinical global impression measure of improvement

  7. Cardiotoxicity

    Time frame: 2 weeks

    Change from baseline EKG regarding QT interval

  8. Plasma levels

    Time frame: weeks 2 and 12

    Fluoxetine dosage and Clomipramine plasmatic dosages (when applies)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Novartis

Registry information

Official study title

Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study

Acronym: EPMTOC

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 27, 2007
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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