Tag: Treatment

STARD – Treatment used in the Study

NIMH Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study — All Medication Levels

The NIMH-funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study was conducted to determine the effectiveness of different treatments for people with major depression who have not responded to initial treatment with an antidepressant. This is the largest and longest study ever conducted to evaluate depression treatment. This page provides information about the study.

What were the treatments used in the study?

In level 1, participants were given the antidepressant citalopram (Celexa) for 12 to 14 weeks. Those who became symptom-free during this time could move on to a 12-month follow-up period during which the citalopram was continued, and patients were monitored. Those who experienced intolerable side effects or did not become symptom-free during this level could go on to level 2.

Citalopram is representative of the class of antidepressant medications known as selective serotonin reuptake inhibitors (SSRIs). It was chosen as the first treatment because it generally is not associated with troublesome withdrawal symptoms when it is stopped, is easy to administer (once a day), and has been shown to be safe for older adults and medically fragile patients. It does not appear to interact unfavorably with other medications that some participants may have been taking for other medical problems.

Level 2 was designed to help determine an appropriate next treatment step if the first step did not work. Thus, in level 2, participants had the option of switching to a different medication or adding on to their existing citalopram.

Those who joined the “switch” group were randomly assigned to either sertraline (Zoloft), bupropion-SR (Wellbutrin), or venlafaxine-XR (Effexor). These medications were chosen for comparison because they represent three different types of medications. Sertraline is an SSRI, the same class as the citalopram used in level 1. Bupropion belongs to another class of antidepressant medications that work on different neurotransmitters than SSRIs. Venlafaxine is a “dual-action” medication that works on two neurotransmitters at the same time.

Those who joined the “add-on” group were prescribed either the non-SSRI antidepressant bupropion-SR (Wellbutrin), or buspirone (BuSpar), which is not an antidepressant but enhances the action of an antidepressant medication. Participants could also switch to, or add on, cognitive psychotherapy.

As in level 1, those who became symptom-free with their level 2 treatment could continue with that treatment and entered the follow-up period. Those who did not become symptom-free, or who experienced intolerable side effects, could continue on to level 3.

In level 3, which like level 2 was designed to compare medications that are thought to work differently in the brain and produce different results, participants again had the option of either switching to a different medication or adding on to their existing medication. Those who chose to switch their medication were randomly assigned to either mirtazapine (Remeron) — a different type of antidepressant — or to nortriptyline (Aventyl or Pamelor) — a tricyclic antidepressant — for up to 14 weeks. Both work differently in the brain than the SSRIs and other medications used in levels 1 and 2.

In the level 3 add-on group, participants were randomly prescribed either lithium — a mood stabilizer commonly used to treat bipolar disorder — or triiodothyronine (T3) — a medication commonly used to treat thyroid conditions — to add to the medication they were already taking. These medications were chosen because they have been shown to boost the effectiveness of antidepressant medications.

In level 4, participants who had not become symptom-free in any of the previous levels (and therefore considered to have highly treatment-resistant depression) were taken off all other medications and randomly switched to one of two treatments — the monoamine oxidase inhibitor (MAOI) tranylcypromine (Parnate) or the combination of venlafaxine extended release (Effexor XR) with mirtazapine (Remeron). These treatments were chosen for comparison because previous research had suggested that they may be particularly effective in people who had not received sufficient benefit from other medications.

How were participant’s doses decided and how was their progress measured?

To ensure that every participant had the best chance of recovery with each treatment strategy, a systematic approach called measurement-based care was used. This method requires routine, consistent measurement of symptoms and side effects at each treatment visit with easy-to-use measurement tools. It also involves the use of a treatment manual that describes when and how to modify medication doses and dose adjustments to best tailor them for individual participants so as to minimize side effects, maximize safety, and provide the best chance of therapeutic benefit. This enabled STAR*D practitioners to provide consistent, high-quality care.

STAR*D employed easy-to-use rating tools of symptoms and side effects in a systematic and consistent way. These tools can readily be incorporated into real-world medical and psychiatric settings. Use of this measurement-based care may have caused greater than expected remission rates.

Patients were asked to self-rate their symptoms. The study demonstrated that most depressed patients can quickly and easily self-rate their symptoms and estimate their side effect burden in a very short time. Their doctors can rely on these self-rated tools for accurate and useful information to make informed judgments about treatment. The patients can also use these tools to help manage their illness at home in much the same way that hypertensive patients can measure their own blood pressure.

STARD – Results of the Study on Depression Other Treatments

NIMH Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study — All Medication Levels

The NIMH-funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study was conducted to determine the effectiveness of different treatments for people with major depression who have not responded to initial treatment with an antidepressant. This is the largest and longest study ever conducted to evaluate depression treatment.

What were the results?

In most clinical trials of treatment for depression, the measure of success (outcome) is called “response” to treatment, which means that the person’s symptoms have decreased to at least half of what they were at the start of the trial. In STAR*D, the outcome measure was a “remission” of depressive symptoms—becoming symptom-free. This outcome was selected because people who reach this goal generally function better socially and at work, and have a better chance of staying well than do people who only achieve a response but not a remission.

In level 1, about one-third of the participants reached remission and about 10-15 percent more responded, but did not reach remission. Still, these are considered good results because study participants had high rates of chronic or recurrent depression and other psychiatric medical problems.

It took an average of six weeks of treatment for participants to improve enough to reach a response and nearly seven weeks of treatment for them to achieve a remission of depressive symptoms. In addition, participants visited their care providers an average of five to six times. Participants who achieved remission stayed on the treatment for an average of 12 weeks before going on to a 12-month follow-up period.

In the level 2 switch group, about 25 percent of participants became symptom-free. All three of the switch medications performed about the same and were equally safe and well-tolerated. In the add-on group, about one-third of participants became symptom-free. Those who added bupropion experienced less troublesome side effects and slightly more reduction of symptoms than those who added buspirone.

In levels 2 and 3 where participants were allowed to either add-on or switch medications, most participants found only one or the other treatment strategies acceptable. Because most participants did not agree to be randomly assigned to one or the other treatment strategy, the findings of the add-on and switch approaches cannot be compared. It is likely, however, that people being treated in the real world also tend to limit their treatment preferences to switching or adding on medications. In addition, the people in the switch and add-on groups were a little different. The group who chose and were assigned to a switch medication had more problematic side effects while taking the preceding medication (citalopram) than the group who chose and were assigned to an add-on medication.

Level 2 also included cognitive psychotherapy as a switch or add-on treatment. Results for the psychotherapy treatment are not yet available.

In the level 3 switch group, 12 to 20 percent of participants became symptom-free, and the two medications used fared about equally well, suggesting no clear advantage for either medication in terms of remission rates or side effects. In the add-on group, about 20 percent of participants became symptom-free, with little difference between the two treatments. However, the T3 treatment was associated with fewer troublesome side effects than lithium.

In level 4, seven to 10 percent of participants became symptom-free, with no statistically significant differences between the medications in terms of remission, response rates or side effect burden. However, those taking the venlafaxine-XR/mirtazapine combination experienced more of a reduction in depressive symptoms than those taking the tranylcypromine. Also, those who were treated with tranylcypromine were more likely to discontinue the treatment citing side effects as the reason. It is also possible that the dietary restrictions associated with taking an MAOI could have limited its acceptability as a treatment.

In conclusion, about half of participants in the STAR*D study became symptom-free after two treatment levels. Over the course of all four treatment levels, almost 70 percent of those who did not withdraw from the study became symptom-free. However, the rate at which participants withdrew from the trial was meaningful and rose with each level—21 percent withdrew after level 1, 30 percent withdrew after level 2 and 42 percent withdrew after level 3.

What lessons are learned from the results?

For the first time, doctors and people with depression now have extensive data on antidepressant treatments from a federally funded, large-scale, long-term study directly comparing treatment strategies.

Results from level 2 indicate that if a first treatment with one SSRI fails, about one in four people who choose to switch to another medication will get better, regardless of whether the second medication is another SSRI or a medication of a different class. And if patients choose to add a new medication to the existing SSRI, about one in three people will get better. It appears to make some—but not much—difference if the second medication is an antidepressant from a different class(e.g. bupropion) or if it is a medication that is meant to enhance the SSRI (e.g. buspirone). Because the switch group and the add-on group cannot be directly compared to each other, it is not known whether patients are more likely to get better by switching medications or by adding another medication.

Results from level 3 apply to those who do not get better after two medication treatment steps. By switching to a different antidepressant medication, about one in seven people will get better. By adding a new medication to the existing one, about one in five people will get better. Level 3 results also tell us that adding T3 may have some advantages over adding lithium for patients who have tried two other treatments without success.

Finally, for patients with the most treatment-resistant depression, level 4 results suggest that tranylcypromine is limited in its tolerability and that up to 10 percent may benefit from the combination of venlafaxine-XR/mirtazapine.

An overall analysis of the STAR*D results indicates that patients with difficult-to-treat depression can get well after trying several treatment strategies, but the odds of beating the depression diminish with every additional treatment strategy needed. In addition, those who become symptom-free have a better chance of remaining well than those who experience only symptom improvement. And those who need to undergo several treatment steps before they become symptom-free are more likely to relapse during the follow-up period. Those who required more treatment levels tended to have more severe depressive symptoms and more co-existing psychiatric and general medical problems at the beginning of the study than those who became well after just one treatment level.

These results underscore both the need for a better understanding of how different people respond to different depression treatments, and the challenges in finding broadly effective, short- and long-term depression treatments. Future research may help identify which treatments work for which patients.

What do the STAR*D results mean to people with MDD and their doctors?

The results reiterate the need for high-quality care and attention to the individual needs of patients. Doctors should provide medication at optimal doses, be aware of and offer treatment choices, and maintain diligent monitoring of patients both during treatment and after they become symptom-free so as to avoid relapse.

Like other medical illnesses, depression affects different people in different ways, but a wide range of effective treatments exist. People with depression should not give up if their initial treatment attempts do not result in full benefits. They should continue to work with their doctors to find the best treatment strategy.

In addition, patience is required. While some people may experience benefits in the first six weeks of a treatment strategy, full benefits may not be realized until 10 or 12 weeks have passed. During this time, doctors should work with their patients to adjust dosages so as to find an optimal level, and avoid stopping a treatment prematurely.

STARD Study – What were the goals of trial?

NIMH Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study — All Medication Levels

The NIMH-funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study was conducted to determine the effectiveness of different treatments for people with major depression who have not responded to initial treatment with an antidepressant. This is the largest and longest study ever conducted to evaluate depression treatment. This page provides information about the study.

What were the goals of the STAR*D trial?

The overall goal of the STAR*D trial was to assess the effectiveness of depression treatments in patients diagnosed with major depressive disorder, in both primary and specialty care settings. It is the largest and longest study ever conducted to evaluate depression treatment.

Each of the four levels of the study tested a different medication or medication combination. The primary goal of each level was to determine if the treatment used during that level could adequately treat participants’ major depressive disorder (MDD). Those who did not become symptom-free could proceed to the next level of treatment.

The design of the STAR*D study reflects what is done in clinical practice because it allowed study participants to choose certain treatment strategies most acceptable to them and limited the randomization of each participant only to his/her range of acceptable treatment strategies. No prior studies have evaluated the different treatment strategies in broadly defined participant groups treated in diverse care settings.

Who participated in the study?

Over a seven-year period, the study enrolled 4,041 outpatients, ages 18-75 years, from 41 clinical sites around the country, which included both specialty care settings and primary medical care settings. Participants represented a broad range of ethnic and socioeconomic groups. All participants were diagnosed with MDD and were already seeking care at one of these sites. No media advertisements were used to recruit participants. Instead, they were referred to the trial by their doctors.

So that results could be generalized to a broad group of real-world patients, most adults with MDD were eligible. People were not eligible for the study if they had not tolerated or did not get well with one or more of the treatments that were part of the first two STAR*D treatment steps, or if a STAR*D treatment could not be safely used because of another medical condition or because they were taking certain other medications. In addition, people with substance abuse disorders that required detoxification, anorexia or bulimia, or obsessive compulsive disorder were not eligible for the study because they required treatments that were not part of STAR*D.

Of the initial 4,041 participants, 1,165 were excluded because they either did not meet the study requirements of having “at least moderate” depression (based on a rating scale used in the study) or they chose not to participate. Thus, 2,876 “evaluable” people were included in level 1 results. Level 2 results include 1,439 people who did not become symptom-free in level 1 and chose to continue. Level 3 results include 377 people, and Level 4 results include 142 people.

7 Strengths for 7 Stressors of Today

The modern world today has been the worst all across human history for the stress effects on our daily life. There are many people who are feeling the psychological burden. Lot of us are feeling very tired and withdrawn from everyday routine and daily activities. The constant exposure to media is aggravating the situation towards the downward spiral because of the environmental and social events happening all around us and in the world we live.

Here are some of the top stressors in the current times and how we can overcome them to live a simple yet fulfilling life. Following the tips will mobilize your strengths towards achieving greater resilience and buoyancy in daily life.

1. The world is going through tough times and going to a shallow bottom – there are many horrific events like fires, earthquakes, hurricanes, and flooding. The political environment all around is also not giving any sense of stability either.

To cope up, remember that in all the times of despair and calamity, we see many resources being mobilized by people to care for others whom they do not know or never met. This is the human nature which has made us coexist since so long. The feeling of altruism, sympathy, and empathy are still in all of us fundamentally. Be helpful and provide hope for yourself and others.

2. Are we destroying our planet and making it inhabitable – The population of the world has been growing ad currently it is over populated, due to which we are consuming more and more resources. This causes Earth to suffer due to waste, deterioration of resources, oil reserves, etc.

Well, think that the basic step starts from you. We must do all that we can individually and collectively to make our planet better.

3. Feeling Lonely – We are living in a mobile world where people are moving constantly for school, work, leisure, etc. Therefore, we are often lonely with extended family living at distance, whether hundred miles or thousands of miles. Disintegration of community and relatives is making us get lesser and lesser emotional support.

To cope up with feeling of loneliness, we do need to be with others and feel part of a group. Invite friends over for dinner or extended an invitation to someone for coffee. Be inspired and extend yourself to an activity or an invitation and savor some connection.

4. There is so much anger around us with people upset naturally always. – The frustrations of life comes out in any form at any time with minimal or no provocation at all. Well, you might have heard it million times before, but the coping mechanisms remain same – exercise, meditation, friends and family, vacation time, etc are all the ways to reduce the daily life frustration. Do what you enjoyed once and stopped doing it due to time and its relevance.

5. How can I help or how can I get help – Healthy stepping back from your own world can take you to the longer road of good and destressed life. Keep in mind that grief and loss are part of life. What does loss or grief mean to you? How have you managed your own loss or grief in life? What helped, what didn’t? How can you cultivate them? Time to introspect and help others introspect.

6. Accept that stress is part of life – When stressful situations arise, remind yourself that they are part of life and will come and go. Nothing in this life is permanant – neither does your stress. So take a relaxed approch towards stress in life.

7. Have a realistic outlook about everything in your life. Do not see the world through rose-coloured glasses rather have your own outlook which is realistic. You also need to check the silver lining in the tough circumstances. Stressful circumstances are there to make you become stronger and better.

Stopping Meds Leads To Relapse

Caution for Stopping Psychiatric Medication Abruptly – All you need to know about Relapse

Why people decide to stop taking medicines? Do they know it can cause more harm than benefit?

Well the answer according to the study conducted by Dr. Banov, lies in the thought of people that they might feel better by stopping medicines and thinks they don’t need them anymore. Their family might be pressuring them to stop when they read some nasty feedback or side effect of the medicine.  Many a times, people stop taking medicines when they are experiencing a major change in life like change of job, divorce, changing house, etc. According to psychologists, this is the worst time to stop taking medicines.

There are many other mental health conditions which need the medicines to be taken perpetually. There would be a disaster if they are stopped in between.

Depending on the type of medicine, stopping them suddenly can create many reactions which can range from mild to moderate during early days of discontinuation to even life threatening seizures in some cases in the later phases when the disease relapses with much more severity.

Remember – You should always consult your doctor before stopping any medicine. Do not ever attempt to do it you’re your own thoughts and decision.

Stopping medication is not a quick process

Safe and slow process of drug discontinuation lasts for more than many weeks or months rather than many days. Drugs like antidepressants, takes weeks to show their results; similarly their withdrawal is also spread over several weeks.

Causes and Trigger of Relapses

The environmental cues like people, places, sights and sounds experienced by an addict are among the primary triggers of any kind of relapses which happens to a person.

First we need to understand the triggers. These can be a person, a place, events, or unresolved psychiatric issues, such as depression. While undergoing a treatment for drug addiction, doctors tell the patients to stay away from triggers such as old friends who are still on drugs, stressful situations, etc.

Does relapse to drug abuse mean treatment has failed?

Relapse rates for people with addiction and other substance abuse disorders are similar to rates for other medical illnesses such as diabetes, hypertension, etc. Treatment of these chronic diseases has many changes in behavior and personality. When relapse occurs, it cannot be concluded that the treatment has failed. It just suggests that the treatment needs to be reinstated or adjusted, rather than suggesting the failure of treatment.

Video Games Relieve Depression

Can Video Games Help Relieve the Symptoms of Depression?

According to research and multiple studies conducted across the western world, there is promising results shown in the treatment of depression with a video game interface which fights with underlying cognitive issues associated with depression. They just do not manage the symptoms only.

Different studies on Depression and Video Games

There were many studies conducted on the implications of video games on depression. The first study enrolled older adults diagnosed with late-life depression into a treatment trial where they were randomized to receive either a mobile, tablet-based treatment technology developed by Akili Interactive Labs called Project: EVO or an in-person therapy technique known as problem-solving therapy (PST).

Project: EVO was an app running on tablets or mobile phone and was designed to improve focus and attention at a basic neurological level. The people who were using the app from Project: EVO demonstrated specific cognitive benefits compared to the behavioral therapy, and saw similar improvements in mood and self-reported function.

Joaquin A. Anguera, from University of California, San Francisco (UCSF), who is a researcher in neurology and psychiatry, performed this study and intervention manufactured by Akili Interactive Labs, Boston was used.  The study is funded by National Institute of Mental Health.

As per another research study going on at the University of California, Davis – using video games and brain training applications can help treat depression. The study found that not only can video games potentially treat depression, but when participants are reminded to play games, they are more likely to play more often and increase time playing.

An App, a Video Game, and a Placebo for Depression

A larger trial was conducted with more than 600 participants having mild or moderate depression. These participants assessed the value of different video games in the treatment of depression. One group played Project: EVO, second used an app called iPST, while the third used placebo control who used an app called Health Tips, suggesting health suggestions.

For mild depression, all three groups’ experienced similar improvements, while people who had more than mild depression saw greater improvements with iPST and Project: EVO than with the placebo app.

Video game has nothing to do with mental health, but it can help fixing brain function in people who suffer from this particular flavor of depression.

Video Games Relieve Depression

Video Games has the power to relieve depression

Researchers have found promising results for treating depression with a video game interface that targets underlying cognitive issues associated with depression rather than just managing the symptoms.

According to Dr. Patricia Areán, a UW Medicine researcher in psychiatry and behavioral sciences, the findings are both intriguing and promising.  The first study enrolled older adults diagnosed with late-life depression into a treatment trial where they were randomized to receive either a mobile, tablet-based treatment technology developed by Akili Interactive Labs called Project: EVO or an in-person therapy technique known as problem-solving therapy (PST).

Project:EVO

The Project: EVO runs on phones and tablets and is designed to improve focus and attention at a basic neurological level. The results showed that the group using Project: EVO demonstrated specific cognitive benefits (such as attention) compared to the behavioral therapy, and saw similar improvements in mood and self-reported function. The studies were funded by the National Institute of Mental Health.

Another research on Video Games effects on Depression

Researchers at the University of California Davis are using video games and brain training applications to treat depression. The study found that not only can video games potentially treat depression, but when participants are reminded to play games, they are more likely to play more often and increase time playing, which may help patients gain further benefit from the treatment, though the researchers did not measure that.

The study used six, three-minute specifically designed video games played by 160 student participants with an average age of 21. The study showed in most cases playing a game helped participants feel they had some control over their depression. The games were an adaptation of neurophysiological training tasks shown to improve cognitive control in people with depression.

The messages used to remind participants to play the video games targeted depression as either internal from a chemical imbalance or hereditary, or external from environmental and lifestyle factors. The reminder messages had differences in approach but all concluded with inspirational notes to encourage participants to play the game.