Seroquel Research Study - Screening Visit

I had my evaluation appointment for the Seroquel study on August 30th. First I had to read and sign a 15-page "informed consent" paper that included a detailed explanation of how the study works. Highlights:

You have been asked to take part in this research study because you are experiencing a depressive episode of your bipolar disorder. This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating your depression. This treatment will be compared with placebo (a tablet that looks like a quetiapine tablet, but has no medicine in it), and paroxetine (known as Paxil ...), a very commonly prescribed medication for depression. Approximately 700 other patients like you will take part in about 8 countries.

The study consists of three parts. [I was at the end of the screening phase, which was for discontinuing prior medications and getting some laboratory tests run.]

[T]he acute phase is to try to clear up your depressive symptoms. You will be treated with quetiapine, placebo, or paroxetine for 8 weeks.

[T]he continuation phase is to see if we can prevent the return of your symptoms. If you gained some benefit from the study treatment, you may continue in the study for a further 26 to 52 weeks. You will be treated with quetiapine or placebo in this phase.

You have a 2 in 6 chance of receiving quetiapine 300mg, 1 2 in 6 chance of receiving quetiapine 600mg, a 1 in 6 chance of receiving placebo, and a 1 in 6 chance of receiving paroxetine. Neither you nor your Study Doctor or research nurse will know which treatment you are taking.

The paper also listed how often I would visit the doctor, what would be done at the visits, the common and uncommon side effects of Seroquel and Paxil, how often lab tests would be done, and a barrage of legal language regarding confidentiality, sharing of medical information, what would be paid for if I had medical or psychiatric problems, and how to withdraw from the study. A second form asked for permission to draw some blood for the bipolar genome project. I didn't think twice about that - an opportunity to contribute to understanding the genetics of manic depression? You bet!

Once I had signed, there were several pages of questionnaires to be filled out. For example, I had to rate my satisfaction with things like living conditions, social life, sex life, physical health, ability to work, etc.

After I finished the questionnaires, Eric, the investigator, took me through a lengthy list of questions. As I was so excited about participating, I'll wager my manner and behavior were an odd contrast to some of the answers I gave to questions. "When was your last depressive episode?" Well, heck - it seems like I've been in one forever. I don't recall when it started. I'd have to go back and read all my previous articles to figure it out. "How many manic or hypomanic episodes have you had?" Um. Three? 1980, 1994 (Prozac-induced) and 1997. "Surgeries?" Three, 1970, 1987 and 2003. "Ever suicidal?" No, "and if I ever say yes, lock me up, because it will be really unusual."

The last thing I had to do was drive to a nearby lab to give four vials of blood and a urine specimen, and have an EKG. Eric told me they might have the results in time to give me meds on Friday, but more likely I'd have to wait until the following Tuesday - Monday being Labor Day.

My notes for the next several days are sketchy; highlights are:

• Tuesday: night not too bad.
• Wednesday: bad night.
• Thursday: up at 3:00 am for an ice pack and ibuprofen due to neck pain.
• Friday: call from pdoc's office - I'm approved for the study, pick up meds Tuesday morning. *sigh*
• Saturday: up 7:45, down 10:15, up 11:45. Had manicure and pedicure. Down again 3:15, up 6:15. That's a lot of sleep! To bed, 12:15 a.m.
• Sunday: awake 1:10 and 3:30 a.m. Up to bathroom 5:30, awake 8:30, up 9:30. Bad teeth grinding. Actually worked on cleaning up the deck for 50 minutes - bad costochondritis pain at first, but I kept going and it eased. Discouraged that 50 minutes hard work didn't make any visible improvement in the chaos on the deck.
• Monday (Labor Day): mentally agile, physically blah.

At this point I had been off all my psychiatric meds for 12 days. The severe pain I had experienced during withdrawal from Ativan had let up, though muscle tension and stiffness remained. Some nights I slept better than others, but at no time was my sleep high quality. Through this period I continued to need chiropractic adjustments every other day. My work day continued to be approximately 10:30 a.m. to 5:00 pm ... getting up and getting moving in the morning remained very difficult. I spent a lot of time glued to coverage of Hurricane Katrina, donating money to animal rescue efforts. By the morning of Tuesday, September 6th, I was as "normal" (for me) as I had been in a long time, and I was eager to start the study!