Selective serotonin reuptake inhibitor: Difference between revisions

Latest revision as of 03:25, 20 March 2025

Class of antidepressants

Selective serotonin reuptake inhibitors (SSRIs) are a class of pharmacological agents primarily used to treat depression, anxiety disorders, and other psychological conditions. SSRIs work by increasing serotonin levels in the brain by inhibiting its reuptake, thereby improving mood and emotional stability.

SSRIs are among the most commonly prescribed antidepressants worldwide due to their efficacy, tolerability, and relatively mild side-effect profile. Popular SSRIs include:

Fluoxetine (Prozac)
Sertraline (Zoloft)
Paroxetine (Paxil)
Citalopram (Celexa)
Escitalopram (Lexapro)
Fluvoxamine (Luvox)

Mechanism of Action[edit]

SSRIs function by blocking the serotonin transporter (SERT), which prevents serotonin reuptake at synapses. This increases serotonin availability in the synaptic cleft, thereby enhancing neurotransmission in the serotonergic system, which is crucial for mood regulation, emotion, and cognition.

Unlike tricyclic antidepressants (TCAs) or monoamine oxidase inhibitors (MAOIs), SSRIs specifically target serotonin without significantly affecting norepinephrine or dopamine, which contributes to their lower side effect profile.

Therapeutic Uses[edit]

SSRIs are prescribed for several psychiatric and psychological conditions, including:

1. Major Depressive Disorder (MDD)[edit]

SSRIs are the first-line pharmacological treatment for moderate to severe depression. They are recommended when psychotherapy alone is insufficient. Studies indicate that SSRIs can significantly reduce depressive symptoms and prevent relapse.

2. Anxiety Disorders[edit]

SSRIs are widely used for treating generalized anxiety disorder (GAD), social anxiety disorder (SAD), and panic disorder (PD). Their efficacy in reducing excessive worry and fear makes them a primary treatment option.

3. Obsessive-Compulsive Disorder (OCD)[edit]

SSRIs, particularly fluvoxamine, fluoxetine, and sertraline, are FDA-approved for OCD treatment. Higher doses may be required for obsessive-compulsive symptoms, and combination with cognitive behavioral therapy (CBT) improves outcomes.

4. Post-Traumatic Stress Disorder (PTSD)[edit]

Fluoxetine and paroxetine are the only FDA-approved SSRIs for PTSD. They are used to reduce intrusive thoughts, nightmares, and hyperarousal symptoms.

5. Eating Disorders[edit]

SSRIs, particularly fluoxetine, are prescribed for bulimia nervosa and binge eating disorder. They help reduce compulsive eating behaviors and improve impulse control.

6. Premenstrual Dysphoric Disorder (PMDD)[edit]

Sertraline and fluoxetine are commonly prescribed for PMDD, a severe form of premenstrual syndrome (PMS) characterized by mood swings, irritability, and depression.

Side Effects[edit]

While SSRIs are generally well-tolerated, they can cause side effects, particularly in the first few weeks of treatment. Common side effects include:

Gastrointestinal issues – nausea, diarrhea, dry mouth
Neurological symptoms – headache, dizziness, insomnia, drowsiness
Sexual dysfunction – reduced libido, anorgasmia, erectile dysfunction
Weight changes – slight weight gain or loss
Emotional blunting – reduced emotional responsiveness

Most side effects subside over time, but persistent or severe reactions should be reported to a healthcare provider.

Discontinuation Syndrome[edit]

Stopping SSRIs abruptly can lead to withdrawal-like symptoms known as SSRI Discontinuation Syndrome. Symptoms include:

Flu-like symptoms
Dizziness, nausea
Sensory disturbances ("brain zaps")
Anxiety, irritability
Insomnia

To prevent withdrawal effects, SSRIs should be tapered gradually under medical supervision.

Drug Interactions[edit]

SSRIs interact with multiple medications, increasing the risk of serotonin syndrome, a potentially life-threatening condition. Patients should avoid:

Other antidepressants:
Monoamine oxidase inhibitors (MAOIs)
Tricyclic antidepressants (TCAs)
Serotonin-norepinephrine reuptake inhibitors (SNRIs)
Pain medications:
Tramadol
Meperidine (Demerol)
Other interactions:
St. John's Wort – Increases serotonin levels, leading to serotonin syndrome
MDMA (Ecstasy) – Can cause dangerous serotonin spikes
Dextromethorphan – Found in cough medicines, may trigger interactions

Special Considerations[edit]

Pregnancy and Breastfeeding[edit]

Some SSRIs, such as fluoxetine and sertraline, are considered relatively safe during pregnancy.
However, paroxetine has been associated with congenital heart defects.
SSRIs can pass into breast milk, but are generally considered safe for breastfeeding mothers.

Suicide Risk[edit]

In young adults (under 25), SSRIs may increase suicidal thoughts during the first few weeks of treatment.
Close monitoring is recommended during initial treatment and dosage adjustments.

Comparison with Other Antidepressants[edit]

Comparison of SSRIs with Other Antidepressants
Class	Example Drugs	Mechanism of Action	Side Effect Profile	Special Considerations
SSRIs	Fluoxetine, Sertraline	Selective serotonin reuptake inhibition	Mild, well-tolerated	First-line for depression and anxiety
SNRIs	Venlafaxine, Duloxetine	Inhibits serotonin & norepinephrine reuptake	Increased blood pressure	Used in depression & chronic pain
TCAs	Amitriptyline, Nortriptyline	Blocks serotonin & norepinephrine reuptake	More sedation, weight gain	Effective but more side effects
MAOIs	Phenelzine, Selegiline	Blocks monoamine oxidase (MAO)	Dietary restrictions (tyramine)	Used for treatment-resistant depression

External Links[edit]

The following are antidepressant subclasses and drugs

MAO Inhibitors Isocarboxazid, Phenelzine, Tranylcypromine

SNRIs Duloxetine, Levomilnacipran, Venlafaxine

SSRIs Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Vilazodone, Vortioxetine

Tricyclics Amitriptyline, Amoxapine, Clomipramine, Desipramine, Doxepin, Imipramine, Nortriptyline, Protriptyline, Trimipramine

Miscellaneous Bupropion, Flibanserin, Mirtazapine, Nefazodone, Trazodone

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@@ Line 1: / Line 1: @@
-[[File:Vincent Willem van Gogh 002.jpg|thumb|SSRIs can help people who are [[depression (mental illness)|depressed]], like this "[[sadness|sorrowing]] old man" painted by [[Vincent van Gogh]]]]
+{{Short description|Class of antidepressants}}
-'''Selective serotonin reuptake inhibitors''' ('''SSRIs''') are a class of [[pharmacological]] agents primarily used in the treatment of [[depression]], [[anxiety disorders]], and several other psychological conditions.
+{{Use dmy dates|date=March 2025}}
+{{Infobox drug class
+| name = Selective serotonin reuptake inhibitors (SSRIs)
+| image = Vincent Willem van Gogh 002.jpg
+| caption = SSRIs can help people who are [[depression (mental illness)|depressed]], like this "[[sadness|sorrowing]] old man" painted by [[Vincent van Gogh]]
+| width = 250px
+| class = [[Antidepressants]]
+| atc_prefix = N06AB
+| mode_of_action = [[Serotonin reuptake inhibitor]]
+| biological_target = [[Serotonin transporter]] (SERT)
+| used_for = [[Major depressive disorder]], [[anxiety disorders]], [[obsessive-compulsive disorder]], [[PTSD]], [[eating disorders]]
+| risks = [[Serotonin syndrome]], [[sexual dysfunction]], [[withdrawal symptoms]]
+| legal_status = Prescription-only in most countries
+| related_drugs = [[Serotonin-norepinephrine reuptake inhibitors]] (SNRIs), [[Tricyclic antidepressants]] (TCAs), [[Monoamine oxidase inhibitors]] (MAOIs)
+}}
-SSRIs are among the most frequently prescribed [[antidepressants]] across the globe due to their efficacy and tolerability<ref name="PRESCORN2004">{{Cite book|authors=Preskorn, Sheldon H.; Ross, Ruth; Stanga, Christine Y. |chapter=Selective Serotonin Reuptake Inhibitors |editors=Sheldon H. Preskorn, Hohn P. Feighner, Christina Y. Stanga and Ruth Ross|title=Antidepressants: Past, Present and Future |publisher=Springer |location=Berlin |year=2004 |pages=241–62 |isbn=978-3-540-43054-4}}</ref>. Widely used SSRIs include [[fluoxetine]] (Prozac), [[paroxetine]] (Paxil), [[citalopram]] (Celexa), and [[escitalopram]] (Lexapro).
+'''Selective serotonin reuptake inhibitors''' ('''SSRIs''') are a class of [[pharmacological]] agents primarily used to treat depression, anxiety disorders, and other psychological conditions. SSRIs work by increasing serotonin levels in the brain by inhibiting its reuptake, thereby improving mood and emotional stability.
-== Therapeutic Indications ==
+SSRIs are among the most commonly prescribed antidepressants worldwide due to their efficacy, tolerability, and relatively mild side-effect profile. Popular SSRIs include:
-SSRIs are utilized in the management of a variety of mental health disorders, including<ref name="PRESCORN2004"/>:
+* [[Fluoxetine]] (Prozac)
+* [[Sertraline]] (Zoloft)
+* [[Paroxetine]] (Paxil)
+* [[Citalopram]] (Celexa)
+* [[Escitalopram]] (Lexapro)
+* [[Fluvoxamine]] (Luvox)
-* [[Major depressive disorder]]
+== Mechanism of Action ==
-* Various [[anxiety disorders]] such as [[obsessive-compulsive disorder]] (OCD), [[panic disorder]], and [[generalized anxiety disorder]] (GAD)
+SSRIs function by blocking the serotonin transporter (SERT), which prevents serotonin reuptake at synapses. This increases serotonin availability in the synaptic cleft, thereby enhancing neurotransmission in the serotonergic system, which is crucial for mood regulation, emotion, and cognition.
-* [[Post-traumatic stress disorder]] (PTSD)
-* [[Eating disorder]]s
-* Certain types of [[chronic pain]]
-== Depression ==
+Unlike tricyclic antidepressants (TCAs) or monoamine oxidase inhibitors (MAOIs), SSRIs specifically target serotonin without significantly affecting norepinephrine or dopamine, which contributes to their lower side effect profile.
-In the treatment of severe depression, SSRIs are often the first-line pharmacological intervention. For patients with moderate depression that is unresponsive to [[psychotherapy]], SSRIs can provide symptom relief<ref name=nicedpsn/>. The effectiveness of SSRIs in the treatment of mild, transient depression remains a topic of ongoing research and debate<ref name=nicedpsn>{{cite web |author=<!-- None listed - staff writers --> |title=Depression in Adults: Recognition and Management |website=National Institute for Health and Care Excellence |publisher=RCPsych Publications |location= |year=2009 |pages= |isbn= |url=http://www.nice.org.uk/guidance/cg90}}</ref>.
-== Anxiety Disorders ==
+== Therapeutic Uses ==
-For individuals diagnosed with GAD, SSRIs have demonstrated effectiveness in reducing [[anxiety]], thereby facilitating participation in therapeutic interventions such as cognitive behavioral therapy<ref name = Kapczinski>{{cite journal | author = Kapczinski F; Lima MS; et al. 2003 | title = Antidepressants for generalized anxiety disorder | journal = The Cochrane Database of Systematic Reviews | volume =  | issue = 2 | pages = CD003592 | pmid = 12804478 | doi = 10.1002/14651858.CD003592 | url =  | editor1-last = Kapczinski | editor1-first = Flavio FK }}</ref>. SSRIs are also considered a first-line treatment for severe OCD. While not curative, the use of SSRIs in conjunction with psychotherapy improves treatment outcomes<ref>{{cite journal | author = Arroll B; Elley CR; et al. 2009 | title = Antidepressants versus placebo for depression in primary care | journal = The Cochrane Database of Systematic Reviews | volume =  | issue = 3 | pages = CD007954 | pmid = 19588448 | doi = 10.1002/14651858.CD007954 | url =  | editor1-last = Arroll | editor1-first = Bruce }}</ref><ref name=ocd>{{cite web |url= http://www.medscape.com/viewarticle/570825  |title=Review Finds SSRIs Modestly Effective in Short-Term Treatment of OCD |last1=Busko |first1=Marlene |last2= |first2= |date=February 28, 2008 |website=Medscape |publisher= |accessdate=February 26, 2016 |archiveurl= https://web.archive.org/web/20130413110435/http://www.medscape.com:80/viewarticle/570825 |archivedate=April 13, 2013 |quote=}}</ref>.
+SSRIs are prescribed for several psychiatric and psychological conditions, including:
-== PTSD ==
-The United States [[Food and Drug Administration]] has granted approval for the use of fluoxetine (Prozac) and paroxetine (Paxil) in the treatment of PTSD. However, SSRIs are not considered a standalone cure for PTSD and are typically used in combination with psychotherapeutic interventions<ref name=ptsd>{{cite journal|author=Hetrick SE; Purcell R et al. 2010 |title=Combined pharmacotherapy and psychological therapies for post traumatic stress disorder (PTSD)|journal=The Cochrane Database of Systematic Reviews|date=July 7, 2010 |issue=7|pages=CD007316|pmid=20614457|doi=10.1002/14651858.CD007316.pub2}}</ref><ref name=":3">{{Cite journal|title = Pharmacologic alternatives to antidepressants in posttraumatic stress disorder: A systematic review|url = https://www.ncbi.nlm.nih.gov/pubmed/19141307|journal = Progress in Neuro-Psychopharmacology & Biological Psychiatry|issn = 0278-5846|pmc = 2720612|pmid = 19141307|pages = 169–180|volume = 33|issue = 2|doi = 10.1016/j.pnpbp.2008.12.004|author=Berger W; Mendlowicz MV et al. 2009}}</ref><ref name=":4">{{Cite journal|title = World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the pharmacological treatment of anxiety, obsessive-compulsive and post-traumatic stress disorders - first revision|url = https://www.ncbi.nlm.nih.gov/pubmed/18949648|journal = The World Journal of Biological Psychiatry: The Official Journal of the World Federation of Societies of Biological Psychiatry|issn = 1562-2975|pmid = 18949648|pages = 248–312|volume = 9|issue = 4|doi = 10.1080/15622970802465807|authors=Bandelow B; Zohar J et al. 2008}}</ref>. Notably, apart from Prozac and Paxil, most other SSRIs do not appear to significantly improve PTSD symptoms<ref name=Hos2015>{{Cite journal | author = Hoskins M; Pearce J et al. 2015 | title = Pharmacotherapy for post-traumatic stress disorder: systematic review and meta-analysis. | journal = British Journal of Psychiatry | volume = 206 | issue = 2 | pages = 93–100 | doi = 10.1192/bjp.bp.114.148551 | PMID = 25644881 |quote =}}</ref>.
-== Side Effects and Precautions ==
+=== 1. Major Depressive Disorder (MDD) ===
+SSRIs are the first-line pharmacological treatment for moderate to severe depression. They are recommended when psychotherapy alone is insufficient. Studies indicate that SSRIs can significantly reduce depressive symptoms and prevent relapse.
-Like all medications, SSRIs can have side effects. These may include, but are not limited to:
+=== 2. Anxiety Disorders ===
+SSRIs are widely used for treating generalized anxiety disorder (GAD), social anxiety disorder (SAD), and panic disorder (PD). Their efficacy in reducing excessive worry and fear makes them a primary treatment option.
-* Nausea
+=== 3. Obsessive-Compulsive Disorder (OCD) ===
-* Diarrhea
+SSRIs, particularly fluvoxamine, fluoxetine, and sertraline, are FDA-approved for OCD treatment. Higher doses may be required for obsessive-compulsive symptoms, and combination with cognitive behavioral therapy (CBT) improves outcomes.
-* Dry mouth
+=== 4. Post-Traumatic Stress Disorder (PTSD) ===
+Fluoxetine and paroxetine are the only FDA-approved SSRIs for PTSD. They are used to reduce intrusive thoughts, nightmares, and hyperarousal symptoms.
+=== 5. Eating Disorders ===
+SSRIs, particularly fluoxetine, are prescribed for bulimia nervosa and binge eating disorder. They help reduce compulsive eating behaviors and improve impulse control.
+=== 6. Premenstrual Dysphoric Disorder (PMDD) ===
+Sertraline and fluoxetine are commonly prescribed for PMDD, a severe form of premenstrual syndrome (PMS) characterized by mood swings, irritability, and depression.
+== Side Effects ==
+While SSRIs are generally well-tolerated, they can cause side effects, particularly in the first few weeks of treatment. Common side effects include:
+* Gastrointestinal issues – nausea, diarrhea, dry mouth
+* Neurological symptoms – headache, dizziness, insomnia, drowsiness
+* Sexual dysfunction – reduced libido, anorgasmia, erectile dysfunction
+* Weight changes – slight weight gain or loss
+* Emotional blunting – reduced emotional responsiveness
+Most side effects subside over time, but persistent or severe reactions should be reported to a healthcare provider.
+== Discontinuation Syndrome ==
+Stopping SSRIs abruptly can lead to withdrawal-like symptoms known as SSRI Discontinuation Syndrome. Symptoms include:
+* Flu-like symptoms
+* Dizziness, nausea
+* Sensory disturbances ("brain zaps")
+* Anxiety, irritability
 * Insomnia
-* Drowsiness
-* Dizziness
-* Sweating
-These side effects often improve over time or with a dosage adjustment. However, it's important for patients to report any side effects to their healthcare provider.
+To prevent withdrawal effects, SSRIs should be tapered gradually under medical supervision.
+== Drug Interactions ==
+SSRIs interact with multiple medications, increasing the risk of serotonin syndrome, a potentially life-threatening condition. Patients should avoid:
-== Discontinuation Syndrome ==
+* Other antidepressants:
-Abrupt discontinuation of SSRIs can lead to a withdrawal-like condition known as [[SSRI discontinuation syndrome]]. Symptoms can include flu-like symptoms, insomnia, nausea, imbalance, sensory disturbances, and hyperarousal. Gradual dose reduction is typically recommended to minimize these effects<ref>{{Cite journal | author = Warner CH; Bobo W; Warner C; Reid S; Rachal J | title = Antidepressant discontinuation syndrome | journal = American Family Physician | volume = 74 | issue = 3 | pages = 449–56 | pmid = 16913164 |year=2006}}</ref>.
+* [[Monoamine oxidase inhibitors]] (MAOIs)
+* [[Tricyclic antidepressants]] (TCAs)
+* [[Serotonin-norepinephrine reuptake inhibitors]] (SNRIs)
+* Pain medications:
+* [[Tramadol]]
+* [[Meperidine]] (Demerol)
+* Other interactions:
+* [[St. John's Wort]] – Increases serotonin levels, leading to serotonin syndrome
+* [[MDMA]] (Ecstasy) – Can cause dangerous serotonin spikes
+* [[Dextromethorphan]] – Found in cough medicines, may trigger interactions
+== Special Considerations ==
+=== Pregnancy and Breastfeeding ===
+* Some SSRIs, such as fluoxetine and sertraline, are considered relatively safe during pregnancy.
+* However, paroxetine has been associated with congenital heart defects.
+* SSRIs can pass into breast milk, but are generally considered safe for breastfeeding mothers.
-== Interactions ==
+=== Suicide Risk ===
-SSRIs can interact with a variety of other medications, including other antidepressants, certain pain or headache medications, and the herbal supplement St. John's Wort. These interactions can increase the risk of [[Serotonin syndrome]], a potentially life-threatening condition<ref>{{Cite journal | author = Boyer EW; Shannon M | title = The serotonin syndrome | journal = The New England Journal of Medicine | volume = 352 | issue = 11 | pages = 1112–20 | pmid = 15784664 | doi = 10.1056/NEJMra041867 |year=2005}}</ref>. Always discuss any other medications you are taking with your healthcare provider.
+* In young adults (under 25), SSRIs may increase suicidal thoughts during the first few weeks of treatment.
+* Close monitoring is recommended during initial treatment and dosage adjustments.
-* Some other medicines for depression and anxiety:
+== Comparison with Other Antidepressants ==
-** [[MAOI|Monoamine oxidase inhibitors]] (MAOIs)
+{| class="wikitable"
-** Tricyclic antidepressants
+|+ Comparison of SSRIs with Other Antidepressants
-** [[Serotonin-norepinephrine reuptake inhibitors]] (SNRIs)
+! Class !! Example Drugs !! Mechanism of Action !! Side Effect Profile !! Special Considerations
-** [[Lithium carbonate|Lithium]]
+|-
-** [[Buspirone]] (Buspar)
+| SSRIs || Fluoxetine, Sertraline || Selective serotonin reuptake inhibition || Mild, well-tolerated || First-line for depression and anxiety
-** [[Mirtazapine]] (Remeron)
+|-
-* Some [[Opiate|pain medications]]
+| SNRIs || Venlafaxine, Duloxetine || Inhibits serotonin & norepinephrine reuptake || Increased blood pressure || Used in depression & chronic pain
-** [[Pethidine|Pethidine/meperidine]] (Demerol)
+|-
-** [[Tramadol]] (Ultram)
+| TCAs || Amitriptyline, Nortriptyline || Blocks serotonin & norepinephrine reuptake || More sedation, weight gain || Effective but more side effects
-* Other things
+|-
-** [[Dextromethorphan]], an [[over-the-counter drug|over-the-counter]] [[cough]] medicine
+| MAOIs || Phenelzine, Selegiline || Blocks monoamine oxidase (MAO) || Dietary restrictions (tyramine) || Used for treatment-resistant depression
-** [[St. John's Wort]], an [[herb]] that some people use to treat depression
+|}
-** [[MDMA|MDMA (Ecstasy)]], an [[illegal drug]]
-==Related pages==
+== See Also ==
 * [[Serotonin]]
-* [[Depression (mental illness)|Depression]]
+* [[Depression (mental illness)]]
-* [[Anxiety disorder]]s
+* [[Anxiety disorder]]
+* [[Antidepressant]]
-==References==
+== External Links ==
-{{reflist}}
+{{Medical resources
-{{stub}}
+| DiseasesDB =
+| ICD10 = {{ICD10|N|06|A|b|11}}
+| MedlinePlus =
+| eMedicineSubj = psych
+| eMedicineTopic = selective-serotonin-reuptake-inhibitor
+| MeshID = D017367
+}}
 {{Antidepressants}}
@@ Line 69: / Line 133: @@
 {{OCD pharmacotherapies}}
 {{Monoamine reuptake inhibitors}}
-{{Sigma receptor modulators}}
+{{Sigma receptor modulators}} {{stub}}
-{{DEFAULTSORT:Selective Serotonin Reuptake Inhibitor}}
+[[Category:Selective serotonin reuptake inhibitors]]
-[[Category:Selective serotonin reuptake inhibitors| ]]
 [[Category:Sigma receptor ligands]]
 [[Category:Treatment of obsessive–compulsive disorder]]
 [[Category:Treatment of depression]]

v t e Anxiolytics (N05B)
5-HT_1AR agonists	Buspirone Gepirone Tandospirone
GABA_AR PAMs	Benzodiazepines: Adinazolam Alprazolam Bromazepam Camazepam Chlordiazepoxide Clobazam Clonazepam Clorazepate Clotiazepam Cloxazolam Diazepam^# Ethyl loflazepate Etizolam Fludiazepam Halazepam Ketazolam Lorazepam^# Medazepam Nordazepam Oxazepam Pinazepam Prazepam; Others: Alpidem^‡ Barbiturates (e.g., phenobarbital) Carbamates (e.g., meprobamate) Carisoprodol Chlormezanone^‡ Ethanol (alcohol) Etifoxine
Hypnotics	Zopiclone
Gabapentinoids (α₂δ VDCC blockers)	Gabapentin Gabapentin enacarbil Phenibut Pregabalin
Antidepressants	SSRIs (e.g., escitalopram) SNRIs (e.g., duloxetine) SARIs (e.g., trazodone) TCAs (e.g., clomipramine^#) TeCAs (e.g., mirtazapine) MAOIs (e.g., phenelzine); Others: Agomelatine Bupropion Tianeptine Vilazodone Vortioxetine
Antipsychotics	Quetiapine Flupentixol
Sympatholytics (Antiadrenergics)	Alpha-1 blockers (e.g., prazosin) Alpha-2 agonists (e.g., clonidine, dexmedetomidine, guanfacine) Beta blockers (e.g., propranolol)
Others	Benzoctamine Cycloserine Fabomotizole Hydroxyzine Lorpiprazole Mebicar Mepiprazole Nicotine Opipramol Oxaflozane^‡ Phenaglycodol Phenibut Picamilon Selank Tiagabine Tofisopam Validolum
^#WHO-EM ^‡Withdrawn from market Clinical trials: ^†Phase III ^§Never to phase III