Dextromethorphan + Fluoxetine for Obsessive-Compulsive Disorder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Stanford University
Must be taking: Fluoxetine
Must not be taking: Psychotropic medications
Disqualifiers: Bipolar, Psychotic, Substance use, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing if a common cough medicine can help when taken with a low dose of a usual obsessive-compulsive disorder (OCD) medication. It targets patients with OCD and related disorders who often do not get enough help from current treatments. The cough medicine might work with the usual drug to better control troubling thoughts and actions. The usual medication is a well-established treatment for obsessive-compulsive disorder and has been shown to be effective in multiple studies.
Will I have to stop taking my current medications?
If you are taking any prescribed psychotropic medications other than fluoxetine, you will need to stop them at least 2 weeks before the study starts.
What evidence supports the effectiveness of the drug combination of Dextromethorphan and Fluoxetine for treating Obsessive-Compulsive Disorder?
Research shows that combining fluoxetine with another drug, clomipramine, can be effective for treating obsessive-compulsive disorder, especially when each drug alone is not enough. This suggests that combining fluoxetine with other drugs, like dextromethorphan, might also be beneficial.
12345Is the combination of dextromethorphan and fluoxetine safe for humans?
There is no specific safety data available for the combination of dextromethorphan and fluoxetine, but fluoxetine (also known as Prozac) is generally considered safe for treating conditions like depression and obsessive-compulsive disorder. However, it's important to be cautious about potential drug interactions, as combining medications can sometimes lead to unexpected side effects.
24678How is the drug combination of Dextromethorphan and Fluoxetine unique for treating obsessive-compulsive disorder?
The combination of Dextromethorphan and Fluoxetine for treating obsessive-compulsive disorder is unique because it combines a cough suppressant (Dextromethorphan) with an antidepressant (Fluoxetine), potentially offering a novel mechanism of action compared to traditional treatments that primarily focus on serotonin reuptake inhibition.
234910Eligibility Criteria
This trial is for California residents with OCD, body dysmorphic disorder, illness anxiety disorder, or somatic symptom disorder who can consent to participate. It excludes those with bipolar or psychotic disorders, pregnant or nursing women, recent users of certain psychotropic drugs other than fluoxetine, and individuals with current severe substance use issues.Inclusion Criteria
I have been diagnosed with OCD, BDD, IAD, or SSD.
I understand and can agree to the study's procedures and risks.
Living within California
Exclusion Criteria
Pregnant or nursing women
I have bipolar or psychotic disorder.
Active moderate or severe substance use disorder, lifetime severe substance use disorder
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Phase 1
Participants in Group A take fluoxetine for 4 weeks; Group B takes fluoxetine plus dextromethorphan with increasing doses weekly for 4 weeks
4 weeks
Treatment Phase 2
Participants in Group A continue fluoxetine and add dextromethorphan with increasing doses weekly for 4 weeks; Group B continues fluoxetine alone for 4 weeks
4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the combination of dextromethorphan and fluoxetine for treating symptoms in patients with OCD and related conditions. The goal is to determine how well patients tolerate this combo and its effectiveness in symptom relief.
2Treatment groups
Experimental Treatment
Group I: Group B: fluoxetine plus dextromethorphan then fluoxetineExperimental Treatment2 Interventions
Group B participants will take fluoxetine 20mg (or prior dose) daily together with over the counter dextromethorphan, with doses increasing weekly as tolerated, for 4 weeks, and then will stop dextromethorphan, continuing fluoxetine alone for 4 weeks.
Group II: Group A: fluoxetine then fluoxetine plus dextromethorphanExperimental Treatment2 Interventions
Group A participants will take fluoxetine 20mg (or prior dose) daily for 4 weeks, and will then continue fluoxetine while adding over the counter dextromethorphan, with doses increasing weekly as tolerated, for 4 weeks.
Dextromethorphan is already approved in United States for the following indications:
🇺🇸 Approved in United States as Dextromethorphan for:
- Cough suppression
- Depression (when combined with bupropion as Auvelity)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityStanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
Avy L. & Roberta L. Miller FoundationCollaborator
References
Retrospective Review of Fluvoxamine-Clomipramine Combination Therapy in Obsessive-Compulsive Disorder in Children and Adolescents. [2022]To inform dosing and describe the pharmacokinetic interaction, efficacy and safety of fluvoxamine-clomipramine combination therapy for treatment-resistant pediatric obsessive-compulsive disorder (OCD).
Augmenting selective serotonin reuptake inhibitors with clomipramine in obsessive-compulsive disorder: benefits and risks. [2022]A small body of literature suggests that clomipramine may usefully augment selective serotonin reuptake inhibitor (SSRI) treatment in obsessive-compulsive disorder (OCD) patients who do not respond to SSRI monotherapy. The combination, however, is associated with the risk of clinically significant drug interactions. Clomipramine can raise the blood levels and hence the adverse effects of most SSRIs, and many SSRIs can raise the blood levels and hence the adverse effects of clomipramine. The latter situation is more important because certain dose-dependent adverse effects of clomipramine, such as seizures, can be life-threatening. This article presents an evidence-based discussion of the pharmacodynamic and pharmacokinetic adverse effects of the SSRI-clomipramine combination along with suggestions for dosing and monitoring when the combination is used in OCD.
Treatment of adolescent obsessive-compulsive disorder with a clomipramine-fluoxetine combination. [2014]Clomipramine has been reported to be effective in the treatment of obsessive-compulsive disorder (OCD). Children and adolescents, however, tolerate poorly the adverse effects of tricyclics. Fluoxetine and other serotonin re-uptake inhibitors also appear useful in OCD, and are safer than clomipramine. To maximize the therapeutic effects and minimize adverse effects, 6 adolescents with OCD were treated in single trials with a clomipramine-fluoxetine combination. Duration of combined drug therapy ranged from 4 weeks to more than 28 weeks. Patients were first treated with clomipramine alone; if improvement or adverse effects were unsatisfactory, they received the drug combination. Clinical global improvement with clomipramine alone was moderate in 3 patients and minimal in 3. With a combined clomipramine-fluoxetine therapy, improvements were marked in 5 patients, and moderate in 1. These improvements were obtained with relatively low daily doses: clomipramine at 25 to 50 mg, and fluoxetine at 20 to 40 mg. Adverse effects appeared greater and much less tolerable with clomipramine alone than with the clomipramine-fluoxetine combination. This drug combination was well tolerated. These preliminary data suggest that relatively low doses of a clomipramine-fluoxetine combination may potentiate therapeutic effects and minimize adverse effects in OCD patients. Larger controlled trials are suggested.
The benefits of clomipramine-fluoxetine combination in obsessive compulsive disorder. [2019]We report the benefits of clomipramine-fluoxetine combination in four cases of severe obsessive compulsive disorder. In two cases, the combination was effective when either drug used singly was ineffective. In the other two cases, fluoxetine adjunct produced benefits with no additional side effects.
Obsessive-compulsive disorder: a double-blind, placebo-controlled trial of clomipramine in 27 patients. [2013]Clomipramine was significantly superior to placebo in a 10-week double-blind, placebo-controlled trial in 27 outpatients who met DSM-III-R criteria for obsessive-compulsive disorder.
Potential interactions of methylphenidate and atomoxetine with dextromethorphan. [2019]To examine the potential for drug-drug interactions to influence drug metabolism between the attention-deficit/hyperactivity disorder (ADHD) dl-methylphenidate and atomoxetine with dextromethorphan, a probe for interactions involving cytochrome P450 (CYP) 2D6 isoenzyme.
Fluvoxamine: safety profile in extensive post-marketing surveillance. [2022]The safety profile of the selective serotonin reuptake inhibitor, fluvoxamine, has been assessed in clinical and post-marketing studies. Post-marketing surveillance provides the opportunity to assess a drug's safety in every day clinical conditions in a much greater patient population than in clinical trials and therefore serves as a useful tool to detect signals for adverse effects with an incidence of less than 1 : 10,000. The safety profile of fluvoxamine was evaluated based on data from 17 years of global post-marketing surveillance in an estimated 28 million patients exposed to fluvoxamine. A total of 6,658 adverse drug reaction reports received from world-wide sources were reviewed and analysed. Post-marketing surveillance data confirmed the favourable safety profile already observed in clinical and post-marketing studies. A remarkably low level of suicidality, switch to mania, and sexual dysfunction was found. Serotonin syndrome appeared to be a very rare complication of fluvoxamine treatment. No signals for drug interactions unknown so far were identified. Withdrawal symptoms were observed in everyday clinical conditions, which were generally mild and resolved spontaneously. However, no cases suggestive for drug dependence have been reported. In conclusion, the data presented underlined that fluvoxamine offers a safe and well-tolerated option in the treatment of depression and obsessive-compulsive disorder.
Serotonin syndrome induced by fluvoxamine and mirtazapine. [2022]To document a case of serotonin syndrome associated with the combined use of fluvoxamine and mirtazapine, and to discuss the pharmacodynamic and pharmacokinetic interactions that were the likely causes of this potentially serious adverse drug reaction (ADR).
Effectiveness of long-term augmentation with citalopram to clomipramine in treatment-resistant OCD patients. [2022]The high percentage (between 40% and 60%) of resistance to first-line drugs, such as clomipramine or selective serotonin reuptake inhibitors, is a major problem in the pharmacologic management of obsessive-compulsive disorder (OCD). In these cases, different strategies have been employed with controversial outcomes. The meager information available on the association of two serotonergic drugs prompted us to explore the possible effectiveness and tolerability of citalopram+clomipramine in resistant OCD patients.
Placebo-controlled trial of fluoxetine and phenelzine for obsessive-compulsive disorder. [2022]It is now well documented that fluoxetine is a viable treatment option for patients with obsessive-compulsive disorder (OCD), and there is a small body of evidence indicating that monoamine oxidase inhibitors may be effective in at least a subset of patients. The authors conducted a 10-week placebo-controlled trial of these two agents in patients who met DSM-III-R criteria for OCD.