Study seeks new PMDD treatment

For women suffering from premenstrual dysphoric disorder (PMDD) — a debilitating form of PMS that affects between 3 and 6 percent of women — and from negative side effects of their anti-depressant medication, Yale Psychiatry professor Kimberly Yonkers is searching for a way to ease their monthly pain.

In a current study run by the Yale PMS, Perinatal and Postpartum Research Program, principal investigator Yonkers is examining the success of a new treatment method for women with PMDD that will only require medication during the symptomatic period each month.

Currently, women who suffer from PMDD typically take daily seratonin inhibitors — such as sertraline, commonly known as Zoloft — to combat the monthly effects of PMDD.

The study, which is currently recruiting participants, aims to determine whether patients experience positive results from the treatment even if they do not take it daily.

In the randomized clinical trial, participants have a 50 percent chance of receiving an active medication and a 50 percent chance of receiving a placebo sugar pill, program coordinator Joanne Cunningham said. It will then track these women for six months to determine whether they experience symptom relief with the new treatment method.

If the alternative plan proves successful, researchers said, the advantages would include lower medication costs for the patient and fewer side effects, which can include dry mouth, sweating, difficulty sleeping, tremor and fatigue.

Obstetrics and gynecology professor Joshua Copel said he thinks the study will be useful in improving understanding of PMDD.

“The hormonal levels in women fluctuate through their cycles,” he said. “Since we don’t know exactly what causes PMDD in individual women, it’s hard to know if it’s sufficient to treat them only when they have symptoms.”

PMDD symptoms include depression, mood swings, irritability, anxiety and suicidal feelings — 15 percent of women with PMDD try to kill themselves at some point. Women with PMDD may also experience physical symptoms like sleep, appetite and energy changes, breast pain and bloating.

Prior work by Yonkers has indicated that treatment for half of the menstrual cycle — about 16 to 18 days — showed results, and that every-day treatment is not the only viable option.

“Recently, people have been trying to push the envelope farther to reduce the amount of time patients need to take medication,” she said. “It hasn’t yet been empirically studied, and doctors like to practice treatments with good proof that they work. It’s our job to find something that women can tolerate and that helps them and that minimizes side effects.”

Participants in the study will be recruited through public postings at places like women’s health fairs, as well as through radio and television, Cunningham said. Active recruiting will continue for four years, and the study is expected to last for five years.

The first group of subjects — currently charting their symptoms — is expected to begin treatment in early to mid-December, Cunningham said.

Yonkers said the primary benefit of the study is that, if results are positive and indicate treatment efficacy, women can minimize their medication intake, which she said is a goal for many patients.

But Dr. Margaret Altemus, a co-principal investigator for this study at Cornell University, said the study might also have larger implications than simply improving treatment for women with PMDD.

“It’s very interesting that women can respond so quickly to the [medication], which indicates that the drug might be working in a different way than our current model,” she said. “Maybe people with other subtypes of depression might respond more quickly to medication, too.”

Although Yonkers was hopeful about the study’s clinical results and possible applications, she did not offer any guesses about the outcome. She said she was wary of predicting results.

“We have to approach these things with a certain degree of skepticism,” she said. “And without having done the research, we can’t say for certain what will happen.”

The center is hoping to enroll 300 women in the study from three sites — Yale, Cornell and Virginia Commonwealth University. Participants must be female, between the ages of 18 and 48, have regular menstrual cycles and suffer from severe clinical PMDD, and they must not currently be on anti-depressants or anti-anxiety medication.

Relagen Review


Relagen is a dietary supplement suggested to be used as a mood elevator. This product is manufactured by an undisclosed company, which for obvious reasons is rather concerning. We do believe that consumers have a need to know who is behind the production of their oral products, and do wonder why a company would feel the need to hide behind anonymity. We do suspect this may reflect on the quality level of the product.

According to the web description, Relagen is advertised to relieve stress through the use of all natural ingredients. The website states this supplement is “superior to all prescription options” and has “no side effects.” We will have to take a closer look at the contained formulation to determine if this supplement can perform these advertised functions.

Ingredients at a Glance

Relagen contains the following ingredients in its formulations: Vitamin C, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Relora, Magnolia, L-Theanine, Suntheanine and 5-HTP.

As a whole this supplement contains a variety of essential minerals and vitamins that promote better health, which in turn could increase energy levels.

Ingredients in Focus

We are pleased to see the abundance of vitamins in this formulation. All, are needed for optimum health and have the potential to boost moods if health levels are increased. Though, none have been specifically shown to have a direct effect on mental well being. However, Vitamin B6 may support serotonin levels in the brain, which is said to be the hormone related to happy feelings.

This formulation does contain a strain of Green Tea through the amino acid L-Theanine, which has been widely purported to produce calming effects. However, it also contains levels of caffeine which is a stimulant and may cause adverse effects such as insomnia, jitteriness and nausea for some.

In the end, this formulation may improve overall vitality since it has an assortment of ingredients that are said to support health. Increased vitality can in turn lead to better moods and boosts in energy. Though, it does not appear this formula will have a direct effect on moods and results may be minimal.


We were pleased to find that this supplement has its own website as many manufacturers look over this important online venue. It is fairly comprehensive and even gives a brief explanation and description of each contained ingredients. While it does not cite any research there is an obvious effort to show potential consumers the varying aspects of the supplement.

However, there are no testimonials posted from past consumers on how this supplement may work. In addition, the website attempts to make visitors believe this supplement is endorsed by doctors, yet it is a natural supplement and not a prescriptive drug.


  • Contains an assortment of vitamins
  • Contains amino acids
  • Supplement has its own website


  • Manufacturer undisclosed
  • Expensive
  • No posted testimonials
  • Contains caffeine
  • A Look at the Different Depression and Anxiety Medications

    While it may be easy to recite the various brand names and generalize their benefits enough to know they put us (or are supposed to put us) in a better mood, for lack of a better term, the drugs themselves can all be categorized individually, each working in a slightly different way.

    The following is a list and very brief description, by category, of depression and anxiety medications currently prescribed by physicians.

    Selective Serotonin Reuptake Inhibitors (SSRIs)

    SSRIs, which are fairly new to the arsenal of depression and anxiety medications, have gained immense popularity among prescribing psychiatrists within the past 10 years. They are usually prescribed during the early stages of depression, if a person has sought help and behavioral and/or psychotherapy has not proven effective enough. With appropriate dosage, SSRIs can "catch" depression before it becomes severe. Although they do not work for 20% to 40% of people who try them, their ability to work for people with minor (and even major) depressive illnesses makes them attractive enough to prescribing psychiatrists to try them first before moving on to more serious depression and anxiety medications and methods, if need be. SSRIs work on serotonin, one of the brain's three neurotransmitters.

    SSRIs Brand name (chemical name)

    Celexa (citalopram), Lexapro (escitalopram oxalate), Luvox (fluvoxamine), Paxil (paroxetine), Prozac (fluoxetine), Zoloft (sertraline)

    Monoamine Oxidase Inhibitors (MOAIs)

    MAOIs are the type of depression and anxiety medications that work for people who are mildly depressed, develop mild depression over a long period of time, are overly sensitive to their environment, or who are easily able to emerge from periods of depression. People who demonstrate an excess of a particular activity (ie, overeating, oversleeping, emotional overreaction) as compensation with stress can benefit from MAOIs, which work on the three neurotransmitters (called monoamines) found in the brain: norepinephrine, serotonin, and dopamine. These are usually only prescribed when a person hasn't responded to any of the other types of depression and anxiety medications.

    A strict diet must be followed if taking an MAOI, because in conjunction with certain foods, the body can react with elevated blood pressure, headaches, fluctuating blood sugar (for people with diabetes), and in more severe cases, brain hemorrhage. Because of these risks, MAOIs were taken off the American market for a while, but were reintroduced for patients who haven't had luck with any other depression and anxiety medications.

    MAOIs Brand name (chemical name)

    Nardil (phenelzine), Parnate (tranylcypromine)

    Tricyclic Antidepressants (TCAs)

    Tricyclics have been available longer than any other depression and anxiety medications. In 1958, the first tricyclic, imipramine (Tofranil), was released to help combat major depression, and physicians saw a 70% positive response within their patients. Previously the only treatments for severely depressed patients were amphetamines and electroshock therapy. TCAs increase the brain's supply of serotonin and norepinephrine, two of the brain's three neurotransmitters, but it also affects some of the brain's other nerve impulses as well, and this allows for more side effects.

    Severely depressed and/or hospitalized patients see the most benefit from taking TCAs because of its sedative effect. In the past, patients were usually prescribed tricyclics before anything else, but with the movement of psychiatrists (and patients!) toward heading off depression before it becomes severe and/or chronic, TCAs are now usually only prescribed if the other types of depression and anxiety medications don't work.

    TCAs Brand name (chemical name)

    Adapin (doxepin), Anafranil (clomipramine) , Elavil (amitriptyline), Endep (amitriptyline), Ludiomil (maprotiline), Norpramin (desipramine) , Pamelor (nortryptyline), Pertofrane (desipramine), Sinequan (doxepin), Surmontil (trimipramine), Tofranil (imipramine), Vivactil (protriptyline)

    Non-specified or "Other" depression and anxiety medications

    Because their chemical make-ups do not fit into any of the other categories, the following list of depression and anxiety medications can only be termed as "other." Wellbutrin, Desyrel, Remeron, and Effexor are prescribed most. Each of the four drugs affects at least one of the brain's three neurotransmitters (norepinephrine, serotonin, dopamine), and as a result, each has its own particular set of side effects. As a result, psychiatrists are much more likely to prescribe one of the other types of depression and anxiety medications (SSRIs, MAOIs, TCAs) before switching to one of these. In some instances, a patient's regimen is augmented by combining an SSRI or TCA with an"other" depression and anxiety medications, but because of an MAOI's particular chemical make-up and dietary requirements, it is prescribed alone.

    Brand names (chemical names) of Non-specified depression and anxiety medications

    Buspar (buspirone), Cymbalta (duloxetine), Desyrel (trazodone) , Effexor (venlafaxine), Edronax, Vestra (reboxetine), Remeron (mirtazapine), Serzone (nefazodone), Wellbutrin (bupropion).

    In August of 2004, the FDA approved the investigational drug Cymbalta™ (duloxetine HCl), which demonstrated rapid relief of anxiety symptoms associated with depression that was sustained for the length of the study period, according to new data published in the journal Depression and Anxiety. In clinical studies, researchers attribute the medication's effect on a broad spectrum of depression symptoms, which include emotional and painful physical symptoms as well as anxiety, to its dual reuptake inhibition of both serotonin and norepinephrine.