What side effects are associated with this type of intervention?

Selective Serotonin Reuptake Inhibitors (SSRIs), commonly used to treat Obsessive-Compulsive Disorder (OCD), can cause several side effects. These include gastrointestinal issues such as nausea and diarrhea, sexual dysfunction, insomnia, headache, and increased anxiety initially. Weight gain and fatigue are also reported. While SSRIs are generally well-tolerated, they can sometimes lead to more severe side effects like serotonin syndrome, especially when combined with other serotonergic medications. It's important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several Selective Serotonin Reuptake Inhibitors (SSRIs) for the treatment of Obsessive-Compulsive Disorder (OCD). These include fluoxetine, fluvoxamine, sertraline, and paroxetine. These medications work by increasing serotonin levels in the brain, which helps reduce the symptoms of OCD. Studies have shown that SSRIs are effective in reducing the frequency and severity of obsessive-compulsive behaviors, making them a first-line pharmacological treatment for OCD.

What other types of research exist?

Promising novel alternatives to SSRIs for OCD treatment include memantine and riluzole. Memantine has shown efficacy in several studies, including randomized double-blind placebo-controlled trials, particularly for treatment-resistant OCD. Riluzole has also demonstrated potential as an augmentation strategy in treatment-refractory OCD, supported by pilot randomized placebo-controlled trials.

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Selective Serotonin Reuptake Inhibitor

Fluoxetine for Obsessive-Compulsive Disorder

Phase 1 & 2

Recruiting

Led By Christopher Pittenger, MD, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- No documented or clinically suspected family history in a first- or second- degree relative of OCD, Tourette syndrome, hoarding disorder, body dysmorphic disorder, or a compulsive grooming disorder.

- A DSM diagnosis of OCD, established as detailed above.

Must not have

- Documented nonresponse to a past trial of fluoxetine of appropriate dose (≥40 mg/dy) and duration (≥12 weeks).

Patients taking Coumadin or Monoamine oxidase inhibitors (MAOIs) will be excluded from the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial uses brain scans and fluoxetine to treat unmedicated OCD patients. It aims to see how the brain changes with treatment and identify markers that predict treatment success. Fluoxetine, a selective serotonin reuptake inhibitor (SSRI), has been used for many years to treat obsessive-compulsive disorder (OCD) and is recognized for its efficacy in reducing both obsessions and compulsions.

Who is the study for?

This trial is for adults with Obsessive-Compulsive Disorder (OCD) who are seeking treatment and appropriate for fluoxetine therapy. They must not be on psychoactive medication, pregnant, or have a family history of certain disorders. Healthy controls matched by demographics are also included.

What is being tested?

The study tests the effects of immediate versus delayed treatment with Fluoxetine on brain function in OCD patients using advanced fMRI scans to find predictors and changes associated with the drug's response.

What are the potential side effects?

While side effects aren't detailed here, common ones for Fluoxetine include nausea, headaches, sleep disturbances, anxiety, and sexual dysfunction. The study excludes those with past adverse reactions to SSRIs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My family does not have a history of OCD or related disorders.

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I have been diagnosed with OCD by a professional.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I did not improve after taking fluoxetine (40 mg/day) for 12 weeks.

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I am not taking Coumadin or MAOIs.

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I have never had a major brain injury or serious neurological disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Obsessive-compulsive severity change

Secondary study objectives

"Not Just Right" experiences and sensations in OCD

Anxiety

Beck Depression Inventory-II

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OCD GroupExperimental Treatment2 Interventions

The OCD group will comprise of unmedicated individuals with clinically significant OCD symptoms. OCD Subjects will be randomized, double-blind, to receive immediate or delayed (by 6 weeks as a placebo lead-in) pharmacotherapy.

Group II: Healthy ControlsActive Control1 Intervention

The healthy control group will be an age matched sample of unmedicated healthy adults who will be recruited and imaged once at baseline and the data compared with that of OCD subjects at baseline.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obsessive-Compulsive Disorder (OCD) include Selective Serotonin Reuptake Inhibitors (SSRIs) and clomipramine. SSRIs increase serotonin levels in the brain by inhibiting its reuptake into the presynaptic cell, making more serotonin available to bind to the postsynaptic receptor. Clomipramine, a tricyclic antidepressant, also inhibits the reuptake of serotonin and norepinephrine. These mechanisms are important because serotonin is believed to play a key role in mood regulation and anxiety, which are central to OCD symptoms. By increasing serotonin availability, these medications can help reduce the severity of OCD symptoms, offering patients significant relief and improving their quality of life.

Are 5-HT3 antagonists effective in obsessive-compulsive disorder? A systematic review of literature.Clomipramine enhances the cortisol response to 5-HTP: implications for the therapeutic role of 5-HT2 receptors.Sumatriptan, 5-HT(1D) receptors and obsessive-compulsive disorder.