Major Depressive DisorderPhase 2NCT06746441

Effect of Psilocybin Only and Psilocybin Assisted Cognitive Behavioral Therapy in the Management of Major Depressive Disorder and Associated Metabolic, Immune, Inflammatory, Neuroplasticity and Electrical Activity Markers

A Phase 2 study testing Psilocybin and Cognitive Behavioral Therapy (CBT) in people with Major Depressive Disorder, run by Khyber Medical University Peshawar at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Psilocybin and Cognitive Behavioral Therapy (CBT)
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 sitePakistan
Study dates: 1 Dec 2024to 30 Jul 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Individuals aged 18-70 years.
Diagnosed with Major Depressive Disorder (MDD) according to DSM-V criteria.
Active depressive symptoms as indicated by a score > 16 on the Hamilton Depression
Rating Scale (HAM-D) over the preceding two weeks.
Female participants of childbearing potential must be using a highly effective form of contraception and willing to maintain contraceptive use throughout the study period.
Participants must have been taking one SSRI antidepressant (e.g., citalopram, escitalopram, fluoxetine) for at least 6 weeks with at least 75% adherence.

Who cannot join

Resting blood pressure >140/90 (average of four separate measurements).
Risk of suicidal tendencies as indicated by a score of 3 or higher on item 3 of the HAM-D scale.
Use of multiple SSRIs or any antidepressant not specified in the inclusion criteria.
Presence of concurrent psychiatric disorders (e.g., bipolar disorder, schizophrenia).
Use of psychedelics or ketamine within the last 12 months.
Pregnancy, breastfeeding, or attempting to conceive.

Show all 10Show fewer

History of substance abuse or alcohol use in the last 6 months.
Cardiovascular conditions (e.g., hypertension, stroke history).
History of seizures or epilepsy.
Diabetes (especially insulin-dependent).

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Lady Reading Hospital, Pakistan
Peshawar, Khyber Pakhtunkhwa, 25000

Other trials in Pakistan

About this study

Official title: Effect of Psilocybin Only and Psilocybin Assisted Cognitive Behavioral Therapy in the Management of Major Depressive Disorder and Associated Metabolic, Immune, Inflammatory, Neuroplasticity and Electrical Activity Markers: a Randomized Controlled Trial

This randomized controlled clinical trial evaluates the effectiveness of psilocybin and psilocybin-assisted cognitive behavioral therapy (CBT) in the management of Major Depressive Disorder (MDD). The study aims to compare the effects of psilocybin-only therapy, CBT, and psilocybin-assisted CBT on depression symptoms, neurochemical markers, inflammatory markers, and neuroplasticity in individuals with MDD. Participants will continue their routine depression medications and will be assessed for changes in depression scores, biochemical markers, and brain activity patterns using validated tools and tests.

Read the detailed description

This single-masked randomized controlled trial investigates novel therapeutic interventions for Major Depressive Disorder (MDD). MDD is a leading cause of disability worldwide, with a significant proportion of patients being treatment-resistant or showing only partial response to conventional antidepressants. Emerging evidence suggests that psilocybin, a serotonergic psychedelic, has potential as a rapid-acting antidepressant.

The study will recruit 60 participants meeting DSM-V criteria for MDD, randomized into four groups:

Control group (Conventional therapy only), Psilocybin therapy group, Cognitive Behavioral Therapy (CBT) group, and Psilocybin-assisted CBT group. Participants will receive interventions over 10 weeks, with psilocybin administered in two heroic doses six weeks apart, and CBT delivered in 8-10 structured sessions. Biochemical and neurochemical markers such as CD4/CD8 ratio, TNF-α, IL-6, BDNF, and oxytocin will be measured, along with inflammatory markers (resistin and visfatin). Depression scores will be assessed using scales like HAM-D, MADRS, and BDI. EEG recordings will evaluate changes in brain activity pre- and post-intervention.

The primary objective is to assess improvements in depression symptoms, while secondary objectives include evaluating changes in immune, inflammatory, and neurochemical markers and EEG activity. Data will be analyzed using ANOVA with Tukey's post-hoc tests to determine statistical significance.

Conditions: Major Depressive Disorder
Being tested: Psilocybin, Cognitive Behavioral Therapy (CBT)
Keywords: Psilocybin, Cognitive Behavioral Therapy (CBT), Randomized Controlled Trial, Psychedelic Therapy, Inflammatory Markers
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PsilocybinDrug
Also called Psilocin (the active form of psilocybin metabolized in the body)
Psilocybin is a naturally occurring serotonergic psychedelic compound found in Psilocybe mushrooms. It is metabolized in the body into its active form, psilocin, which has a high affinity for serotonin 5-HT2A receptors. This enables psilocin to bypass the default serotonin pathway, producing antidepressant effects.
For this study:
Psilocybin will be administered orally in a dose of 5-6 grams per session. Each participant in the Psilocybin and Psilocybin-assisted CBT arms will receive two sessions spaced six weeks apart.
The therapy will be conducted in a controlled hospital setting with medical monitoring during the session to ensure safety until the hallucination phase subsides.
Psilocybin will be added to routine antidepressant medication.
Cognitive Behavioral Therapy (CBT)Behavioural
Cognitive Behavioral Therapy (CBT) is a structured, time-limited psychotherapy aimed at alleviating symptoms of depression. It involves addressing negative thoughts and behavioral patterns through the following steps:
Identifying troubling life situations. Recognizing thoughts, emotions, and beliefs about those situations. Identifying negative or inaccurate thinking patterns. Restructuring those thoughts into positive and realistic perspectives.
In this study:
CBT will consist of 8-10 structured sessions, each lasting approximately 90 minutes.
Participants will attend therapy sessions twice weekly over a six-week period. The intervention will be delivered by trained psychotherapists in a controlled hospital setting.
Routine antidepressant medications will be continued alongside CBT.

Study groups in NCT06746441
Study group	Role	What they receive
Psilocybin Therapy Group	Experimental	Participants will receive two oral doses of psilocybin (5-6 grams per dose), administered six weeks apart. Each session will occur in a controlled environment with medical monitoring until the hallucination phase subsides. Participants will continue their routine antidepressant medications during the study. Receives: Drug: Psilocybin
Control Group	No intervention	Participants will continue their routine antidepressant medications (e.g., SSRIs such as citalopram, escitalopram, or sertraline) without any additional intervention.
Cognitive Behavioral Therapy (CBT) Group	Active comparator	Participants will undergo 8-10 structured sessions of Cognitive Behavioral Therapy over six weeks. Each session will last approximately 90 minutes, focusing on restructuring negative thought patterns and addressing depression symptoms. Participants will continue their routine antidepressant medications during the study. Receives: Behavioral: Cognitive Behavioral Therapy (CBT)
Psilocybin-Assisted CBT Group	Active comparator	Participants will receive both psilocybin therapy and Cognitive Behavioral Therapy. Psilocybin will be administered in two oral doses (5-6 grams per dose), six weeks apart, with medical monitoring during sessions. In addition, participants will undergo 8-10 CBT sessions over six weeks. Routine antidepressant medications will be continued. Receives: Drug: Psilocybin; Behavioral: Cognitive Behavioral Therapy (CBT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Depression Scores (Hamilton Depression Rating)
Assessment of changes in depression scores using the Hamilton Depression Rating Scale (HAM-D), a clinician-administered tool for evaluating the severity of depression.
Unit of Measure: Points on the HAM-D scale. The HAM-D consists of 17 items, each assessing a specific depressive symptom. Each item is rated on a 0-4 or 0-2 scale, depending on the item. The total score ranges from 0 to 52. Higher scores indicate greater severity of depressive symptoms.
0-7: Normal 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression
- 23: Very severe depression
Measured: Baseline, Week 6 (end of the first psilocybin session), and Week 10 (end of intervention).
Change in Depression Scores (Montgomery-Åsberg Depression Rating Scale)
Assessment of changes in depression scores using the Montgomery-Åsberg Depression Rating Scale (MADRS), a clinician-administered scale for evaluating depressive symptom severity.
Unit of Measure: Points on the MADRS scale.
The MADRS consists of 10 items, each assessing a specific depressive symptom. Each item is rated on a 0-6 scale. The total score ranges from 0 to 60. Higher scores indicate greater severity of depressive symptoms.
0-12: Normal 13-19: Mild depression 20-34: Moderate depression
- 35: Severe depression
Measured: Baseline, Week 6 (end of the first psilocybin session), and Week 10 (end of intervention).
Change in Depression Scores (Beck Depression Inventory)
Assessment of changes in depression scores using the Beck Depression Inventory (BDI), a self-reported measure designed to evaluate the severity of depression symptoms.
Unit of Measure: Points on the BDI scale.
The BDI consists of 21 items, each assessing a specific depressive symptom. Each item is rated on a 4-point scale. The total score ranges from 0 to 63. Higher scores indicate greater severity of depressive symptoms.
0-13: Normal 14-19: Mild depression 20-28: Moderate depression 29-63: Severe depression
Measured: Baseline, Week 6 (end of the first psilocybin session), and Week 10 (end of intervention).
Change in Anxiety Scores (Beck Anxiety Inventory)
Assessment of changes in anxiety scores using the Beck Anxiety Inventory (BAI), a self-reported questionnaire for evaluating the severity of anxiety symptoms.
Unit of Measure: Points on the BAI scale.
The BAI consists of 21 items, each assessing a specific anxiety symptom. Each item is rated on a 0-3 scale. The total score ranges from 0 to 63. Higher scores indicate greater severity of anxiety symptoms.
0-7: Normal 8-15: Mild anxiety 16-25: Moderate anxiety 26-63: Severe anxiety
Measured: Baseline, Week 6 (end of the first psilocybin session), and Week 10 (end of intervention).

Secondary outcomes (5)

Change in Brain-Derived Neurotrophic Factor (BDNF) Levels
Assessment of changes in serum BDNF levels from baseline to the end of the intervention.
Unit of Measure: ng/mL.
Measured: Baseline, Week 6, and Week 10
Change in Oxytocin Levels
Assessment of changes in serum oxytocin levels from baseline to the end of the intervention.
Unit of Measure: pg/mL.
Measured: Baseline, Week 6, and Week 10
Change in Inflammatory Markers
Evaluation of changes in serum levels of TNF-α, IL-6, resistin, and visfatin to monitor systemic inflammation.
Unit of Measure: pg/mL or ng/mL, depending on the specific biomarker.
Measured: Baseline, Week 6, and Week 10.
Deviation from Balanced Time Perspective (DBTP)
Measurement of deviation from a balanced time perspective using the Zimbardo Time Perspective Inventory (ZTPI).
Unit of Measure: ZTPI score.
Measured: Baseline, Week 6, and Week 10.
EEG Pattern Changes
Analysis of changes in EEG activity patterns before and after the intervention, focusing on frequency bands (e.g., Alpha, Beta, Theta, and Delta waves) and their relative power across these bandwidths.
Unit of Measure: Relative power (percentage or dB).
Measured: Baseline, Week 6, and Week 10.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202430 Jul 2025

First posted24 Dec 2024
Study start1 Dec 2024
Primary completion1 Jun 2025
Study completion30 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment (The study has four distinct intervention groups: Control, Psilocybin Therapy, CBT, and Psilocybin-assisted CBT.)
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06746441
Sponsor's protocol ID: KMU/DIR/CTU/2024/011
Status last verified: Aug 2025
First submitted: 9 Dec 2024
Last updated: 2 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The study will make individual participant data (IPD) available to other researchers after the conclusion of the study. The IPD shared will include anonymized data related to the primary and secondary outcome measures, including depression scores, biochemical markers (e.g., TNF-α, IL-6, BDNF), EEG data, and other relevant clinical and demographic data collected during the trial. The data will be de-identified to ensure participant confidentiality. The data will be shared through an approved data repository or by direct request to the study's primary investigators.

Publications

Lee YJ, Lee GW, Seo WS, Koo BH, Kim HG, Cheon EJ. Neurofeedback Treatment on Depressive Symptoms and Functional Recovery in Treatment-Resistant Patients with Major Depressive Disorder: an Open-Label Pilot Study. J Korean Med Sci. 2019 Nov 4;34(42):e287. doi: 10.3346/jkms.2019.34.e287.
PubMed 31674161
MacCallum CA, Lo LA, Pistawka CA, Deol JK. Therapeutic use of psilocybin: Practical considerations for dosing and administration. Front Psychiatry. 2022 Dec 1;13:1040217. doi: 10.3389/fpsyt.2022.1040217. eCollection 2022.
PubMed 36532184
Dodd S, Norman TR, Eyre HA, Stahl SM, Phillips A, Carvalho AF, Berk M. Psilocybin in neuropsychiatry: a review of its pharmacology, safety, and efficacy. CNS Spectr. 2023 Aug;28(4):416-426. doi: 10.1017/S1092852922000888. Epub 2022 Jul 11.
PubMed 35811423
Mertens LJ, Wall MB, Roseman L, Demetriou L, Nutt DJ, Carhart-Harris RL. Therapeutic mechanisms of psilocybin: Changes in amygdala and prefrontal functional connectivity during emotional processing after psilocybin for treatment-resistant depression. J Psychopharmacol. 2020 Feb;34(2):167-180. doi: 10.1177/0269881119895520. Epub 2020 Jan 16.
PubMed 31941394
Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443.
PubMed 36322843

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Psilocybin Only and Psilocybin Assisted Cognitive Behavioral Therapy in the Management of Major Depressive Disorder and Associated Metabolic, Immune, Inflammatory, Neuroplasticity and Electrical Activity Markers: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06746441
Acronym / sponsor ID: KMU/DIR/CTU/2024/011
Conditions: Major Depressive Disorder
Keywords: Psilocybin, Cognitive Behavioral Therapy (CBT), Randomized Controlled Trial, Psychedelic Therapy, Inflammatory Markers
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Khyber Medical University PeshawarUniversity, hospital or other
Study start: 1 Dec 2024 (actual)
Primary completion: 1 Jun 2025 (actual)
Study completion: 30 Jul 2025 (actual)
First posted: 24 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will recruit 60 participants meeting DSM-V criteria for MDD, randomized into four groups:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4
Model description: Parallel Assignment (The study has four distinct intervention groups: Control, Psilocybin Therapy, CBT, and Psilocybin-assisted CBT.)

Arm	Type	Receives
Psilocybin Therapy Group	Experimental	Drug: PsilocybinParticipants will receive two oral doses of psilocybin (5-6 grams per dose), administered six weeks apart. Each session will occur in a controlled environment with medical monitoring until the hallucination phase subsides. Participants will continue their routine antidepressant medications during the study.
Control Group	No intervention	–Participants will continue their routine antidepressant medications (e.g., SSRIs such as citalopram, escitalopram, or sertraline) without any additional intervention.
Cognitive Behavioral Therapy (CBT) Group	Active comparator	Behavioral: Cognitive Behavioral Therapy (CBT)Participants will undergo 8-10 structured sessions of Cognitive Behavioral Therapy over six weeks. Each session will last approximately 90 minutes, focusing on restructuring negative thought patterns and addressing depression symptoms. Participants will continue their routine antidepressant medications during the study.
Psilocybin-Assisted CBT Group	Active comparator	Drug: Psilocybin, Behavioral: Cognitive Behavioral Therapy (CBT)Participants will receive both psilocybin therapy and Cognitive Behavioral Therapy. Psilocybin will be administered in two oral doses (5-6 grams per dose), six weeks apart, with medical monitoring during sessions. In addition, participants will undergo 8-10 CBT sessions over six weeks. Routine antidepressant medications will be continued.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Individuals aged 18-70 years.
Diagnosed with Major Depressive Disorder (MDD) according to DSM-V criteria.
Active depressive symptoms as indicated by a score > 16 on the Hamilton Depression
Rating Scale (HAM-D) over the preceding two weeks.
Female participants of childbearing potential must be using a highly effective form of contraception and willing to maintain contraceptive use throughout the study period.

Key exclusion criteria (10 listed)

Resting blood pressure >140/90 (average of four separate measurements).
Risk of suicidal tendencies as indicated by a score of 3 or higher on item 3 of the HAM-D scale.
Use of multiple SSRIs or any antidepressant not specified in the inclusion criteria.
Presence of concurrent psychiatric disorders (e.g., bipolar disorder, schizophrenia).
Use of psychedelics or ketamine within the last 12 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PsilocybinAlso: Psilocin (the active form of psilocybin metabolized in the body)Psilocybin is a naturally occurring serotonergic psychedelic compound found in Psilocybe mushrooms. It is metabolized in the body into its active form, psilocin, which has a high affinity for serotonin 5-HT2A receptors. This enables psilocin to bypass the default serotonin pathway, producing antidepressant effects. For this study: Psilocybin will be administered orally in a dose of 5-6 grams per session. Each participant in the Psilocybin and Psilocybin-assisted CBT arms will receive two sessions spaced six weeks apart. The therapy will be conducted in a controlled hospital setting with medical monitoring during the session to ensure safety until the hallucination phase subsides. Psilocybin will be added to routine antidepressant medication.	Drug	Psilocybin Therapy Group, Psilocybin-Assisted CBT Group
Cognitive Behavioral Therapy (CBT)Cognitive Behavioral Therapy (CBT) is a structured, time-limited psychotherapy aimed at alleviating symptoms of depression. It involves addressing negative thoughts and behavioral patterns through the following steps: Identifying troubling life situations. Recognizing thoughts, emotions, and beliefs about those situations. Identifying negative or inaccurate thinking patterns. Restructuring those thoughts into positive and realistic perspectives. In this study: CBT will consist of 8-10 structured sessions, each lasting approximately 90 minutes. Participants will attend therapy sessions twice weekly over a six-week period. The intervention will be delivered by trained psychotherapists in a controlled hospital setting. Routine antidepressant medications will be continued alongside CBT.	Behavioural	Cognitive Behavioral Therapy (CBT) Group, Psilocybin-Assisted CBT Group

Primary outcome

Change in Depression Scores (Hamilton Depression Rating)
Time frame: Baseline, Week 6 (end of the first psilocybin session), and Week 10 (end of intervention).
Assessment of changes in depression scores using the Hamilton Depression Rating Scale (HAM-D), a clinician-administered tool for evaluating the severity of depression. Unit of Measure: Points on the HAM-D scale. The HAM-D consists of 17 items, each assessing a specific depressive symptom. Each item is rated on a 0-4 or 0-2 scale, depending on the item. The total score ranges from 0 to 52. Higher scores indicate greater severity of depressive symptoms. 0-7: Normal 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression * 23: Very severe depression
Change in Depression Scores (Montgomery-Åsberg Depression Rating Scale)
Time frame: Baseline, Week 6 (end of the first psilocybin session), and Week 10 (end of intervention).
Assessment of changes in depression scores using the Montgomery-Åsberg Depression Rating Scale (MADRS), a clinician-administered scale for evaluating depressive symptom severity. Unit of Measure: Points on the MADRS scale. The MADRS consists of 10 items, each assessing a specific depressive symptom. Each item is rated on a 0-6 scale. The total score ranges from 0 to 60. Higher scores indicate greater severity of depressive symptoms. 0-12: Normal 13-19: Mild depression 20-34: Moderate depression * 35: Severe depression
Change in Depression Scores (Beck Depression Inventory)
Time frame: Baseline, Week 6 (end of the first psilocybin session), and Week 10 (end of intervention).
Assessment of changes in depression scores using the Beck Depression Inventory (BDI), a self-reported measure designed to evaluate the severity of depression symptoms. Unit of Measure: Points on the BDI scale. The BDI consists of 21 items, each assessing a specific depressive symptom. Each item is rated on a 4-point scale. The total score ranges from 0 to 63. Higher scores indicate greater severity of depressive symptoms. 0-13: Normal 14-19: Mild depression 20-28: Moderate depression 29-63: Severe depression
Change in Anxiety Scores (Beck Anxiety Inventory)
Time frame: Baseline, Week 6 (end of the first psilocybin session), and Week 10 (end of intervention).
Assessment of changes in anxiety scores using the Beck Anxiety Inventory (BAI), a self-reported questionnaire for evaluating the severity of anxiety symptoms. Unit of Measure: Points on the BAI scale. The BAI consists of 21 items, each assessing a specific anxiety symptom. Each item is rated on a 0-3 scale. The total score ranges from 0 to 63. Higher scores indicate greater severity of anxiety symptoms. 0-7: Normal 8-15: Mild anxiety 16-25: Moderate anxiety 26-63: Severe anxiety

5 secondary outcomes

Change in Brain-Derived Neurotrophic Factor (BDNF) Levels
Time frame: Baseline, Week 6, and Week 10
Change in Oxytocin Levels
Time frame: Baseline, Week 6, and Week 10
Change in Inflammatory Markers
Time frame: Baseline, Week 6, and Week 10.
Deviation from Balanced Time Perspective (DBTP)
Time frame: Baseline, Week 6, and Week 10.
EEG Pattern Changes
Time frame: Baseline, Week 6, and Week 10.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
Background: PubMed 31674161Lee YJ, Lee GW, Seo WS, Koo BH, Kim HG, Cheon EJ. Neurofeedback Treatment on Depressive Symptoms and Functional Recovery in Treatment-Resistant Patients with Major Depressive Disorder: an Open-Label Pilot Study. J Korean Med Sci. 2019 Nov 4;34(42):e287. doi: 10.3346/jkms.2019.34.e287.
Background: PubMed 36532184MacCallum CA, Lo LA, Pistawka CA, Deol JK. Therapeutic use of psilocybin: Practical considerations for dosing and administration. Front Psychiatry. 2022 Dec 1;13:1040217. doi: 10.3389/fpsyt.2022.1040217. eCollection 2022.
Background: PubMed 35811423Dodd S, Norman TR, Eyre HA, Stahl SM, Phillips A, Carvalho AF, Berk M. Psilocybin in neuropsychiatry: a review of its pharmacology, safety, and efficacy. CNS Spectr. 2023 Aug;28(4):416-426. doi: 10.1017/S1092852922000888. Epub 2022 Jul 11.
Background: PubMed 31941394Mertens LJ, Wall MB, Roseman L, Demetriou L, Nutt DJ, Carhart-Harris RL. Therapeutic mechanisms of psilocybin: Changes in amygdala and prefrontal functional connectivity during emotional processing after psilocybin for treatment-resistant depression. J Psychopharmacol. 2020 Feb;34(2):167-180. doi: 10.1177/0269881119895520. Epub 2020 Jan 16.
Background: PubMed 36322843Goodwin GM, Aaronson ST, Alvarez O, Arden PC, Baker A, Bennett JC, Bird C, Blom RE, Brennan C, Brusch D, Burke L, Campbell-Coker K, Carhart-Harris R, Cattell J, Daniel A, DeBattista C, Dunlop BW, Eisen K, Feifel D, Forbes M, Haumann HM, Hellerstein DJ, Hoppe AI, Husain MI, Jelen LA, Kamphuis J, Kawasaki J, Kelly JR, Key RE, Kishon R, Knatz Peck S, Knight G, Koolen MHB, Lean M, Licht RW, Maples-Keller JL, Mars J, Marwood L, McElhiney MC, Miller TL, Mirow A, Mistry S, Mletzko-Crowe T, Modlin LN, Nielsen RE, Nielson EM, Offerhaus SR, O'Keane V, Palenicek T, Printz D, Rademaker MC, van Reemst A, Reinholdt F, Repantis D, Rucker J, Rudow S, Ruffell S, Rush AJ, Schoevers RA, Seynaeve M, Shao S, Soares JC, Somers M, Stansfield SC, Sterling D, Strockis A, Tsai J, Visser L, Wahba M, Williams S, Young AH, Ywema P, Zisook S, Malievskaia E. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. N Engl J Med. 2022 Nov 3;387(18):1637-1648. doi: 10.1056/NEJMoa2206443.
Individual participant dataSharing planned: Yes. The study will make individual participant data (IPD) available to other researchers after the conclusion of the study. The IPD shared will include anonymized data related to the primary and secondary outcome measures, including depression scores, biochemical markers (e.g., TNF-α, IL-6, BDNF), EEG data, and other relevant clinical and demographic data collected during the trial. The data will be de-identified to ensure participant confidentiality. The data will be shared through an approved data repository or by direct request to the study's primary investigators.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr Mahvash Khan principal investigator

Hayat Abad Medical Complex, Peshawar

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin and Cognitive Behavioral Therapy (CBT) in people with Major Depressive Disorder, run by Khyber Medical University Peshawar at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Depression Scores (Hamilton Depression Rating) (time frame: Baseline, Week 6 (end of the first psilocybin session), and Week 10 (end of intervention).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06746441, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.