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Breast Cancer Drug Tames Acute Mania in Bipolar Disorder
By Judith Groch, Senior Writer, MedPage Today
September 12, 2007
BETHESDA, Md., Sept. 12 - Tamoxifen significantly decreased symptoms of acute mania beginning as early as 5 days in patients with bipolar disorder in a small pilot study.

The drug, approved to treat breast cancer, maintained its effect throughout a 3 week trial with a response rate of 63% for tamoxifen vs. 13% for placebo, Carlos A. Zarate, Jr., M.D., of the National Institute of Mental Health & colleagues reported online in the Sept. issue of Bipolar Disorders.

Tamoxifen is a relatively selective protein kinase C inhibitor with the advantage that it crosses the blood-brain barrier, the researchers wrote.

They reasoned that because tamoxifen inhibits protein kinase C directly, it would produce anti-manic effects more rapidly than previously achieved with lithium or valproate (Depacon).

Those 2 drugs, they said, exert their primary effect considerably upstream of protein kinase C & ultimately work through an indirect cascade of events.

Although there have been substantial gains with lithium, valproate, carbamazepine & atypical antipsychotic drugs, the researchers said, those drugs may take more than a week to start working & many patients don't respond adequately to or can't tolerate the side effects of the treatment.

The researchers acknowledge that tamoxifen is unlikely to become the drug of choice because it may cause endometrial cancer if taken for extended periods.

However, they noted, by pointing to protein kinase C as a target for new medications, the study raises the possibility of developing faster-acting treatments for the often-destructive early manic phase of the illness.

The tamoxifen findings came from a double-blind, placebo-controlled pilot study of 16 patients with manic or mixed bipolar disorder, with or without psychotic features.

The study included 14 men & two women, mean age 35.4, with a mean length of illness of 16.4 years & a mean duration of the current manic episode of 33.9 days. Of these more than 1/2 had a lifetime diagnosis of any substance abuse or dependence.

The patients were randomly assigned to receive tamoxifen (20-140 mg/day) or placebo for 3 weeks. Primary efficacy was assessed by the Young Mania Rating Scale.

The 8 patients on tamoxifen showed significant improvement in mania compared with placebo as early as 5 days (d=0.59, 95% CI, 0.17-1.00), a 50% or greater effect that remained significant throughout the 3 week trial (d=1.11, CI, 0.59-1.64).

The placebo group showed no significant change from baseline at any point.

After 3 weeks, the researchers said, the effect size for the drug difference was "very large" (d=1.08, 95% C.I., 0.45 to 1.71 (P=0.001).

At the end of the study, response rates were 63% for tamoxifen (5 of 8 patients) & 13% (1 of 8) for placebo (Fisher's Exact P=0.12), the researchers reported.

The tamoxifen group showed a decrease of 18.3 points from baseline to endpoint on the Young Mania scale, while the placebo patients' mania worsened 4.7 points. These findings support the results of an earlier single-blind study & that of other recent studies with tamoxifen, the researchers said.

Lorazepam (Ativan) was used during the trial for 4 of the tamoxifen patients & 6 of the placebo patients. And it has been suggested that the anti-manic effects seen with tamoxifen were related to the lorazepam, which also has anti-manic effects.

However, the researchers noted, lorazepam dose as a time-dependent covariate didn't alter the tamoxifen results.

Overall, tamoxifen was well tolerated, they said, with loss of appetite the main side effect. Contrary to previous reports that tamoxifen might cause depression, the researchers said they found no such effect.

An unavoidable limitation of the study, the researchers noted, is that tamoxifen isn't entirely protein kinase C-selective & also has anti-estrogen effects. Thus, they said, they couldn't clearly exclude the potential contributory effect of estrogen receptor blockade.

The preliminary results of this pilot study need to be interpreted with caution, Dr. Zarate said. First, the group size was small, although the results were sufficiently positive to suggest pursuing larger controlled trials with protein kinase inhibitors in mania.

Second, the results may not be generalizable to patients with certain characteristics, i.e., those with current substance abuse disorders. Finally, he said, these results may not apply beyond the acute treatment phase of bipolar mania.

The findings of this pilot study suggest that protein kinase inhibition might be relevant to the anti-manic effects of lithium and valproate. Large controlled studies with selective protein kinase C inhibitors in acute bipolar mania are warranted, the researchers said.

source: medpage today

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