Bipolar World thanks Dr. Ivan Goldberg, MD for permission to use this
revised Dec 5, 1999
FAQ: Topiramate (Topamax), Mood
Disorders and PTSD.
NOTE: Topiramate is only approved for the
treatment of people with seizures. There are
no systematic studies that establish the safety
or efficacy of topiramate as a treatment
for people with mood disorders or PTSD.
While such studies are getting underway, what is
currently known about the use of topiramate
for the control of mood disorders and PTSD comes
from uncontrolled case reports.
is topiramate (Topamax)?
is an anticonvulsant that is chemically unrelated to any other
or mood regulating medication. The mechanism of action is
was topiramate approved for marketing in the USA and for what
may it be promoted?
received final approval for marketing in the USDA on 24
1996 and is labeled for use as an anticonvulsant.
3. Is a
generic version of topiramate available?
no generic topiramate as the manufacturer has patent protection.
4. How does
topiramate differ from other mood stabilizing drugs?
differs from other mood stabilizing drugs in two major ways:
frequent effectiveness for patients who have failed to respond
or mood stabilizers;
unique side-effect profile.
if anything, uniquely distinguishes topiramate from carbamazepine and
has been successful in controlling rapid cycling and mixed bipolar
in people who have not received adequate relief from carbamazepine
with what sorts of disorders are candidates for treatment with
It is too
early to be very specific about which mood disorders are most likely
to treatment with topiramate. There are just about no published
on topiramate's use in psychiatry. Patients with hard-to-treat bipolar
have been treated more often than patients with
seems especially useful when it comes to treating people who have
manic as the result treatment with lamotrigine.
recently been a report regarding the control of the symptoms of
7. Is topiramate
useful for the treatment of acute depressed, manic and mixed
and can it also be used to prevent future episodes of mania and/or
use of topiramate was to treat people with depressed, manic
and mixed states that did not respond to existing medications.
are now being maintained on topiramate on a long term basis
in an attempt
to prevent future episodes. The effectiveness of topiramate as a
prophylactic agent is currently being established.
8. Are there
any laboratory tests that should precede the start of topiramate
is prescribed the patient should have a thorough medical
including blood and urine tests, to rule out any medical condition,
thyroid disorders, that may cause or exacerbate a mood disorder.
9. How is
treatment with topiramate initiated?
is usually initially prescribed at an initial dose of 12.5 -25 mg once
a day and the total daily dose is increased by 12.5 - 25 mg every week.
in addition to other anticonvulsants being used as mood
the final dose is often between 100 and 200 mg per day. Some
with Bipolar Disorder do well on as little as a total daily dose of 50
When used for the control of the symptoms of PTSD the average
is about 175 mg/day (with a range of 25 - 500 mg/day).
there any special problems prescribing topiramate for people taking
carbamazepine (Tegretol), or valproate (Depakene, Depakote)?
between lithium and topiramate has not been reported.
and valproate both have the ability to lower plasma levels of
. . . carbamazepine by about 50% and valproate by about 15%.
has no effect on the plasma level of carbamazepine but can
the plasma level of valproate by about 10%. Pharmacokinetic
between topiramate and either lamotrigine (Lamictal) or
(Neurontin) have not been reported.
is the usual final dose of topiramate?
as a mood-stabilizing agent the final dose of topiramate is most
50 and 200 mg/day. Some people require doses as high as 400
to achieve a good mood stabilizing effect . . . especially when
is being used as a monotherapy . . . while others do fine on 25
long does it take for topiramate to 'kick-in?'
people notice the antimanic and antidepressant effects early in
others have to take a therapeutic amount of topiramate for up to a
being aware of a significant amount of improvement.
are the side-effects of topiramate?
a listing of topiramate's side effects that affected 10% or more of the
taking the drug during clinical trials and the frequency of those
in the 419 people treated with placebo in those trials:
Common Adverse Reactions (%)
(Topiramate = 200 mg/day)
Adverse Reaction Topiramate
Vision problems 28
Speech problems 17
Psychomotor slowing 17
"Pins and needles" 15
Memory problems 12
are most noticeable the few days after an increase in dose and
side-effects are severe enough to force people to discontinue
that most frequently caused people to discontinue therapy
were: psychomotor slowing (4.1%), memory problems (
fatigue (3.3%), confusion (3.2%), and somnolence (3.2%).
topiramate have any psychiatric side effects?
reported side effects of topiramate are sedation, psychomotor
agitation, anxiety, concentration problems, forgetfulness, confusion,
and depersonalization. As with other anticonvulsants, psychosis
been reported as a side-effect.
does topiramate interact with prescription and over-the-counter
Only a few
interactions between topiramate and other drugs have been
Topiramate may increase the plasma level of phenytoin (Dilantin).
lowers the concentration of topiramate in the blood by about 50%.
has little effect on the plasma level of carbamazepine, the
may decrease the plasma level of topiramate by about 50%. Valproate
the plasma level of topiramate by about 15%. Topiramate may lead to
effectiveness of some oral anticontraceptives.
with other prescription and over-the-counter drugs are not
17. Is there
an interaction between topiramate and alcohol?
may increase the severity of the side-effects of topiramate.
18. Is topiramate
safe for a woman who is about to become pregnant, pregnant
is has been placed in the FDA pregnancy Category C:
studies have shown an adverse effect on the fetus but there are no
studies in humans; The benefits from the use of the drug in pregnant
be acceptable despite its potential risks . . . ."
19. Is topiramate
safe for children and adolescents?
has recently approved the use of topiramate in children.
topiramate be used in elderly people?
seem to handle topiramate similarly to younger ones. There is
experience using topiramate for the treatment of psychiatric disorders
21. Do symptoms
develop if topiramate is suddenly discontinued?
no specific symptoms that have been described following the abrupt
of topiramate, other than the seizures that sometimes follow
discontinuation of any anticonvulsant. Only when necessary because
of a serious
side effect, should topiramate be suddenly discontinued.
22. Is topiramate
toxic if taken in overdose?
only limited data on the effects of overdoses of topiramate. There
no reports of deaths following an overdose.
topiramate be taken along with MAO inhibitors?
combination has been used without any special problems.
does topiramate cost?
As of 5
November1999, an on-line pharmacy (Planet Rx) was selling
for the following amounts per tablet (when bought in lots of 100
25 mg - $1.15
100 mg - $2.61
200 mg - $2.86
topiramate be effective in people who have failed to receive benefit
use of topiramate in psychiatry is with people who have mood
that have not been adequately controlled by other medications at
lamotrigine and gabapentin. A developing use is for people
are the advantages of topiramate?
seems to be effective in some people with bipolar mood disorders
not responded to lithium and/or other mood-stabilizers. Some
who have not been able to tolerate any antidepressant because of
to mania or increased speed or intensity of cycling, or because of the
of mixed states, have been able to tolerate therapeutic doses of
when taking topiramate.
people, topiramate has tolerable side effects and it can be taken
loss that accompanies topiramate therapy in some instances is
for those individuals who have gained weight while taking other mood
drugs. In some studies 20-50% of people taking topiramate lost
are the disadvantages of topiramate?
has only been available for a relatively short time, it was first
in 1996, there is no information about long term side-effects. As its
people with mood disorders started even more recently, it is not
people who initially do well on topiramate continue to do so after
increases the probability of kidney stones. the development of
stones may be prevented by increasing one's intake of water.
should physicians prescribe, and patients take, topiramate, when there
regulating medications that have been available for many years and
been shown to be effective in double-blind placebo- controlled
two major reasons why physicians prescribe and patients take
rather than conventional, better established drugs. They are that
benefits from treatment with the older, better known drugs, and
patients find the side effects of the established drugs to be
has not been a good psychopharmacologic treatment for people with
offers such people the possibility of medically -induced
29. Is topiramate
available in countries other than the USA?
is available in countries in South America, and Europe.
anything been published on the use of topiramate as a therapeutic agent
with mood disorders?
on the use of topiramate as a treatment for people with mood
and PTSD have been presented at various psychiatric meetings, little
is in print
about the psychiatric uses of this medication. The following
are relevant to the psychiatric uses of topiramate::
presented at 39th Annual Meeting New Clinical Drug Evaluation
(NIMH) Boca Raton, Florida, June 1-4, 1999.
topiramate treatment of post-traumatic stress disorder.
JR, van Kammen DP, Shelton MD, et al
Psychiatric Association Annual Meeting 1999, New Research
in severe treatment-refractory mania.
Journal of Psychiatry 1999, 156, 968-969.
and weight loss with topiramate.
Faught E, Gelliam F. et al.
1999, 8, 235-237.
symptoms induced by topiramate.
1999, 53, (5, Suppl 2), S53-S67.
and negative psychiatric effects of antiepileptic drugs in patients with
V, Yatham LN, O'Donovan CA, et al
Psychiatric Association Annual Meeting 1999, New Research
in rapid-cycling bipolar women.
of Affective Disorders 1998, 50, 245-251.
topiramate, a new anti-epileptic as a mood stabilizer.
Kuzniecky R, Ho S, et al.
1999, 15, 321-327.
side effects of topiramate, gabapentin, and lamotrigine in healthy
Neurol Psychiat 1996, 63, 320-335.
old and new anticonvulsants in treatment of psychiatric diseases.
Schizophrenia Research 1999, 39, 153-158. Comparative
or bipolar disorder and schizophrenia.
Frye MA, Denicoff KD, et al.
lithium in the treatment of bipolar illness.
additions and corrections to:
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