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The U. S. Food and Drug Administration (FDA) has not approved any drugs for the treatment of behavioral and psychiatric symptoms in the persons with Alzheimer’s or other dementia. Further, No Drugs have been approved for the treatment of Depression in persons who have Alzheimer’s or some other dementia. This fact has apparently had no affect on the medical profession.

The six (6) most commonly or widely prescribed anti-depressant drugs on the market are:

(Arranged in order of frequency of new prescriptions in 2000.)

1. Sertraline (Zoloft)   10.7 million. 

2. Paroxetine (Paxil)   10.49 million. 

3. Fluoxetine (Prozac)   10 million.

4. Citalopram (Celexa)   5.29 million. 

5. Veniafaxine (Effexor)   4.2 million. 

6. Nefazodone (Serzone)   2.34 million.

(Source: IMS Health, July 11, 2002.)

University of Connecticut, (Storrs, Conn.)  in a News Release dated August 13, 1998 states: “Antidepressant drugs effective mainly as a placebo effect of treatment.” “The effectiveness of antidepressants is mainly in the placebo effect of treatment, not in the medication itself, according to a new study by a university of Connecticut psychologist. Seventy five percent of the response to medication for depression was a result of the patient being in treatment, while at the most 25 percent of the response was a true drug affect, asserts, the study by UConn psychologist Irvin Kirsch and former UConn graduate student Guy Sapirstein. (PhD, now a psychologist at Westwood Lodge Hospital in Needham, Mass.)This means that for a typical patient, 75 percent of the benefit obtained from the active drug would also have been obtained from an inactive placebo, Kirsch says. Whether the remaining 25 percent of the drug response is a true effect of the drug or a psychologically triggered response to side effects alone cannot yet be determined.”...”Kirsch and Sapirstein analyzed the changes in 2,318 patients whose primary diagnosis was depression and who had been randomly assigned to either antidepressant medication or placebo in 19 double-blind clinical trials.” “The study was a meta-analysis, a way of mathematically combining results from different studies with different measures. This analysis included 19 studies in which 858 participants received placebos and 1,460 participants received medication.” 

Irving Kirsch and Thomas Moore did a second larger analysis in 2002 that was reported in USA TODAY on 7/7/2002 in their Health and Science Section. “Through a Freedom of Information Act request, two psychologists obtained 47 studies used by the FDA for approval of the six antidepressants prescribed most widely between 1987-99.” “Overall antidepressant pills worked 18% better than placebos, a statistically significant difference but not meaningful for people in clinical settings, says university of Connecticut psychologist Irvin Kirsch. He and co-author Thomas Moore will release their findings July 15 in Prevention and Treatment, an e-journal of the American Psychological Association. More than half of the 47 studies found that patients on antidepressants improved no more than those on placebos, kirsch says.“ (Included in the study were all of the above listed 6 most popular antidepressants.) 

The Harvard Health Letter of December 1^st 2005 states: “Which antidepressant was shown in recent tests to be no more effective than a placebo. (Surprise – it was Zoloft).” 

What does this all mean? It means an overall fraud against the public on a grand scale. It also suggests that there is no real benefit to the person with Alzheimer’s or other dementia when they do not possess the mental capacity to receive placebo benefits.  The Alzheimer’s or other dementia victims have lost the ability to remember, rationalize, reason or think.  The placebo effect is all psychological. 

I recall a lecturer at an Alzheimer's conference, who indicated in the question and answer session that the negative studies usually are never a matter of publication. He indicated that the readers are not interested in the negative studies. They are interested only in the positive studies.

       Note:   The lack of publication of negative studies is verified in an article appearing in the Wall Street Journal on 12 December 2008 by Robert Lee Hotz. The article sub title reads: "Untold numbers of Clincal Trial Results Go Unpublished; Those that are made Public can't Always be Believed." "Among 90 FDA approved drugs betweeen 1998 and 2000 included in a statistical analysis there were: 909 clinical trials - 394 Published in peer-reviewed medical journals. - 515 unpublished." "researchers who reviewed the FDA's regulatory paperwork for dozens of recently approved drugs found that in some clinical trials submitted for publication, conclusions had been changed, statistics revised, and outcomes altered to make treatments look more effective. Among 43 outcomes reported in the FDA filings that did not favor a drug, 20 were never published. In four out of five instances in which the statistical significance of findings was changed from the FDA filing, the published version was more favorable."

The Alzheimer’s Association on their website has a page on Standard Treatments in which they list “Medications for behavioral symptoms.” “Examples of medication commonly used to treat behavioral and psychiatric symptoms of Alzheimer’s disease, listed in alphabetical order, include the following": 

Antidepressant medications for low mood and irritability:  

Citalopram (Celexa) 

Fluoxetine (Prozac) 

Paroxetine (Paxil) 

Sertraline (Zoloft) 

Trazodone (Desyrel) 

The first four on the list are included in the above studies as having little or no value beyond that of a placebo. The first four on this list are also on the list of the most popular drugs on the market.

Article in the Minneapolis Star-Tribune (Ira Rosofsky - Psychologist) 27 March 2009 entitled: "Enough With The Drugging of Old People." Sub title reads: "We spend billions on this practice. Does it make living with dementia any easier? for us, maybe, Not for them." "A survey released in 2002  by the Kaiser Foundation found that the staffs in a typical nursing home spend about two hours and 20 minutes a day with each resident. For the remaining 21 hours and 40 minutes, residents are left to their own (mostly medicated) devices. Where is the comfort in that? Dementia sufferers in nursing homes are not only taking donepezil and memantine but other similarly questionable drugs for depression, anxiety, psychosis or simply being ornery. It is easier to medicate than to engage. And when the chemical restraints don't work, nursing homes use physical restraints...why not admit the failure of medication and instead spend some of that money on more staff to hold the hands of both patients and their families?" Beyond nurturance, the savings could be deiverted to research that might yield not only statistically significant but meaninful and large improvements. Or maybe even a cure."

June’s Experience with Lexapro, Zoloft, Remeron and Paxil: 

In January 2005, before June went into an Alzheimer's facility, Lexapro was prescribed for her when she was experiencing hallucinations and related symptoms. June was removed from the Lexapro after less then 30 days as her symptoms appeared to be aggravated by the drug.  

June was experiencing crying, sadness and other depression type symptoms in the early months of 2005. In June of 2005, June was placed on 50 mgs of Zoloft on the recommendations of the RN who was the Health Care Coordinator ar the Wellstead of Rogers.(an Alzheimer's care facility) This RN assured me that the Zoloft would soon change June's crying and depression like symptoms. This was the same person who days earlier had asked me "Why is June Crying?" My reply was: "because June has Alzheimer's". I had more that I wanted to add to this reply, but did not do so. 

After a few months no appreciable improvement noted. My email to our children on 10/25/2005 reads: “It was an overall bad day for Mom. She cried during most of the noon lunch. She also got angry with me for keeping her from pouring her milk over her food. She said she was going home. She ate only a part of her lunch. After lunch she was taken to the toilet and was upset when she came back. She cried and sat with her head on my shoulder.” 

On 10/28/2005 the Zoloft was increased to 75mgs This increase in dosage resulted in my email of 12/1/2005 to the Director of Operations at the Wellstead:

“June has developed severe tremors in her hands. Yesterday noon she could hardly get a spoon to her mouth. She would not let me help her and became angry with me. For an hour following this episode, June did not know me. She said she had no husband and that we were not married.”  

(Photo on right is June at the Wellstead November 6, 2005)

In an email to my children dated 12/7/2005 I described June’s symptoms: “Mom has always had sad moods, usually on a daily basis - once or multiple times. In the 9 months that Mom has been at the Wellstead, it has been a rare event for me to see her go all day without a sad period....Now her sad moods are longer with less good time between. What alarms me most is that she now also exhibits anger during the moods. I have never felt that the Zoloft was helping her. After 7 months Mom has shown no signs of improvement and seems to be getting worse.”  

When the Zoloft appeared to be having adverse effects on June’s symptoms, she was switched to 15 mgs of Mirtazapine (Remeron) for a few days beginning on 8 December 2005. This decision appeared disasterous. While it removed the tremors from her hands, June had difficulty walking.  My daily log for December 11th, 2005 noted that June "seemed to have difficulty walking and her balance was not good." In an email to our children on 12 December 2005 I wrote: "Yesterday I noted that her walking had become more difficult from what I was used to seeing. Today it was so difficult that simply walking her from the dining area to the T Hall (room) seemed to exhaust her and she went for the closest chair. Wally mentioned (another husband caregiver) noting the same last night. I talked with the doctor and the NP will see Mom on Wednesday. However for the time being they are backing off of the use of the new drug Mirtazapine (Remeron)." Almost immediately the walking difficulty disappeared. On December 21st, 2005 June was started on10 mgs of Paxil. No walking difficulties were noted. However over the year 2006 the Paxil also appeared to have no observable affect on the sadness, June was gradually removed from the Paxil and all antidepressants after April 2007.June had then traveled further into the late stages of Alzheimer’s, her responsiveness had decreased and most of the depression type symptoms had also disappeared.

     Note: After battling Alzheimer's for almost 11 years, an exhausted June was finally called home by God on October 23rd, 2008. Her funeral notice as published in the Minneapolis Star in October 2008 can be seen on this website under the "In Memoriam" label - or just click on:

"June K. (Rolstad) Berg - In Memoriam".

For the story of June’s favorite home at 6025 Gardena Lane and the poem I wrote about this home during a day of deep sadness, click on the below link: (This was June’s home for almost 40 years. It was constructed shortly after the previous home was severely damaged in a tornado. 6025 Gardena Lane was the first home the June participated in the selection and purchase of a lot on a small hill, helped with the design of the home and watched it being constructed. 6025 Gardena Lane had a special place in her heart.)

 “6025 Gardena Lane – June’s Favorite Home”