Nancy A. Melville

April 11, 2013

LA JOLLA, California — Cognitive-behavioral therapy (CBT) involving exposure and ritual prevention is significantly more effective than the antipsychotic drug risperidone in the adjunctive treatment of refractory obsessive-compulsive disorder (OCD), new research shows.

A study conducted by investigators at Columbia University in New York City showed that risperidone was no better than placebo in OCD patients who failed to respond to initial monotherapy with a serotonin reuptake inhibitor (SRI).

Adjunctive CBT, on the other hand, was significantly more effective than either placebo or risperidone.

"The big message is not that antipsychotic augmentation of SRIs never works, but that it only works in a small subset, so if you as a clinician try it and you don't see effects in 4 to 6 weeks, you should take your patient off of it so they don't wind up on an antipsychotic for no reason while having all the bad side effects," said lead author H. Blair Simpson, MD, PhD, professor of clinical psychiatry at Columbia University and director of the Anxiety Disorders Clinic at the New York State Psychiatric Institute.

Dr. H. Blair Simpson

The other big message, added Dr. Simpson, is that the specific type of CBT that shows a favorable chance of offering improvement is exposure and ritual prevention CBT.

"It's important for clinicians to know that not only should they go to CBT therapy before antipsychotic use, they should go to exposure and ritual prevention therapy and not something like stress management, which is very different and would not be as effective," she told Medscape Medical News.

The findings were presented here at the Anxiety and Depression Association of America (ADAA) 33rd Annual Conference.

Surprise Finding

According to investigators, few patients with OCD achieve remission with an SRI alone, and clinicians are commonly faced with the challenge of where to turn next. Because CBT requires time, access, and a commitment from patients, many clinicians find it easier to simply add another drug — usually an antipsychotic.

However, antipsychotics' unfavorable side-effect profile often makes them a less than ideal treatment choice.

To determine whether antipsychotics are effective for treatment-refractory OCD, researchers randomly assigned 100 patients who had received 12 weeks of SRIs but who were still at least moderately ill to receive either 8 weeks of risperidone (n = 40), exposure and ritual prevention (n = 40), or pill placebo (n = 20), while continuing on their SRI regimen.

Exposure and ritual prevention involves confronting thoughts or situations that trigger anxiety (exposure) and making the choice not to respond compulsively after coming in contact with the triggering situation.

At week 8, the researchers found that patients receiving the exposure and ritual prevention CBT had a significantly greater reduction of symptoms on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), based on mixed effects models, compared with patients receiving risperidone (-9.72 [SE = 1.38], P < .0001) and those receiving placebo (-10.10 [SE = 1.68], P < .0001).

As many as 80% of patients receiving CBT had a Y-BOCS decrease of 25% or more, compared with 23% of patients receiving risperidone and 15% receiving placebo (P < .0001).

In addition, 43% in the CBT group achieved remission, defined as Y-BOCS score of 12 or less, compared with only 13% in the risperidone group and 5% in the placebo group (P = .001)

Interestingly, patients receiving risperidone showed no greater improvement than those receiving placebo (-0.38 [SE = 1.72], P = .825).

"Based on previous smaller studies, we expected risperidone to be effective in about a third of patients, but this was a surprise — our sample showed it didn't differ from pill placebo."

Although this study involves the largest sample of patients receiving risperidone in comparison with CBT, Dr. Simpson cautioned that previous findings should also be considered in drawing the correct conclusions.

"I think the careful message is that in our sample, it [risperidone] didn't work, but in prior, smaller studies, it worked for some," she said.

On the basis of these findings, she recommended that clinicians not wait too long before considering taking patients off an antipsychotic if the desired response is not achieved.

Not Reflective of the Real World?

Commenting on the findings for Medscape Medical News, New York–based psychologist Martin N. Seif, PhD, underscored the fact that heavy reliance on medication is a losing proposition for OCD treatment.

"The general rule of thumb is that no medication is going to successfully cure OCD," he said.

But he emphasized that in a real-world situation, CBT can be a daunting proposition.

"Look at it from the provider's point of view: The patient is in front of you. You are already prescribing an SSRI. What is more efficient — write an additional script for an atypical antipsychotic and say, 'take 2,' or try to find another provider who does CBT, tell the patient why that is better for him, follow up to see if the person actually finds someone, checks out the insurance issues, and follows up on the number of sessions?" he explained.

"If the compliance rate is low, why bother? Real-world healing is very different from little research studies," he said.

However, Dr. Simpson countered that compliance with antipsychotics is poor and antipsychotics can lead to significant adverse effects. In addition, she noted that access to CBT is on the rise, with "increasing numbers of therapists being trained, multiple self-help manuals, and even Internet programs to train therapists in CBT or to treat patients. The clinical world is changing," she said.

Dr. Simpson noted that a previous study she conducted along with Edna Foa, MD, at the University of Pennsylvania indicates that OCD patients on SRIs who receive CBT and improve after 8 weeks are likely to maintain those gains at 6 months, and with that in mind, the team is working on a 6-month follow-up of the current study.

"My prediction is patients who continue to be their own therapists during the follow-up period and follow the instruction that their therapist taught them will be the ones to maintain their gains, but we don't know that yet. It's still a hypothesis."

The study received funding from the National Institute of Mental Health. Janssen Pharmaceuticals provided the medication for the study at no cost. Dr. Simpson occasionally provides consultation to industry groups on the therapeutic needs for OCD (last time for Quintiles, Inc, 9/2012). Dr. Seif disclosed no relevant financial relationships.

Anxiety and Depression Association of America (ADAA) 33rd Annual Conference. Abstract 90. Presented April 5, 2013.

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